5-HT1A receptor agonists(Serotonin 1a (5-HT1a) receptor agonists), 5-HT1B receptor agonists(Serotonin 1b (5-HT1b) receptor agonists), 5-HT1D receptor antagonists(Serotonin 1d (5-HT1d) receptor antagonists)

Therapeutic Areas

Other Diseases

Active Indication

Depressive DisorderDepressive Disorder, Major

Inactive Indication

Anxiety DisordersAttention Deficit Disorder With HyperactivityBinge-Eating Disorder+ [9]

Originator Organization

H. Lundbeck A/S

Active Organization

H. Lundbeck A/S

Visum Prius Ltd.

Sun Pharmaceutical Industries Ltd.

+ [3]

Inactive Organization-

Drug Highest PhaseApproved

First Approval Date

US (30 Sep 2013),

Depressive Disorder, Major

RegulationPriority Review (CN)

Structure

Molecular FormulaC18H23BrN2S

InChIKeyVNGRUFUIHGGOOM-UHFFFAOYSA-N

CAS Registry960203-27-4

203

Clinical Trials associated with Vortioxetine Hydrobromide

TCTR20240809003 / Not yet recruitingPhase 1

A Single Dose, Randomized, Open-label, Two-way Crossover Bioequivalence Study of Generic Vortioxetine 20 mg Film-coated Tablets and Reference Product (Brintellix 20 mg film-coated tablets) in Healthy Thai Volunteers under Fasting Conditions

Start Date13 Nov 2024

Sponsor / Collaborator-

NCT06561438 / RecruitingPhase 3IIT

Postoperative Pain Management Following Laparoscopic Cholecystectomy- Vortioxetine

Postoperative pain management is essential and the inability to treat acute pain appropriately in the first 48 postoperative hours represents a risk factor for developing chronic pain. No. study has investigated Vortioxetine as an adjuvant to standard care for postoperative pain management in patients undergoing LC

Start Date21 Aug 2024

Sponsor / Collaborator

Future University in Egypt

CTIS2023-509422-21-00 / Not yet recruiting

- CFA-1034-2-23

Start Date17 Jul 2024

Sponsor / Collaborator-

100 Clinical Results associated with Vortioxetine Hydrobromide

100 Translational Medicine associated with Vortioxetine Hydrobromide

100 Patents (Medical) associated with Vortioxetine Hydrobromide

664

Literatures (Medical) associated with Vortioxetine Hydrobromide

01 Mar 2024·International journal of psychiatry in medicine

The effect of vortioxetine on anhedonia in patients with schizophrenia

Article

Author: Dickov, Aleksandra ; Greš, Alen ; Šagud, Marina

Objective:

Anhedonia is a common symptom of depression, but is also a negative symptom of schizophrenia. The purpose of this study was to examine the effects of vortioxetine on anhedonia in patients with schizophrenia.

Methods:

A total of 120 patients with schizophrenia in remission who met inclusion criteria were randomized 1:1 by the envelope method into intervention and control groups. All participants in both groups were divided into three subgroups based on the antipsychotic therapy they were receiving (olanzapine, risperidone, or aripiprazole). Vortioxetine was administered to those in the intervention group at a fixed dose of 10 mg per day. The Positive and Negative Syndrome Scale (PANSS), Calgary Depression Scale for Schizophrenia (CDSS), and Chapman Scale for Social and Physical Anhedonia (CSPA) were administered. The study lasted 12 weeks. Participants were assessed twice: At baseline and at the end of the study. Six participants dropped out, with 114 completing the trial.

Findings:

Vortioxetine treatment had a significant effect on level of physical anhedonia. The treatment interaction was also statistically significant, but with a relatively small effect (F = 3.17, P < .05; η2 = .061). Vortioxetine treatment had a particularly strong effect on the level of social anhedonia. The interaction between the treatment and the type of antipsychotics was also statistically significant with a small effect (F = 5.04, P < 0. 01; η2 = .091).

Conclusion:

The combination of olanzapine and vortioxetine was found to be the best option to reduce symptoms of social and physical anhedonia in these patients with remitted schizophrenia.

01 Mar 2024·Exploratory research in clinical and social pharmacy

US Medicaid program: An analysis of the spending and utilization patterns for antidepressants from 2017 to 2021

Article

Author: Fuehrlein, Brian ; Elmarasi, Mohamed

Background:

Major depressive disorder (MDD) is a serious mental health condition that contributes to health complications, financial burden and death. In 2020, about one in five US adults had a lifetime diagnosis of MDD. With Major Depressive Disorder (MDD) being a common mental health concern, it is important to understand treatment patterns within public health systems like Medicaid, as they play a crucial role in providing care to diverse populations.

Objective:

The study investigated antidepressant usage and market distribution in the Medicaid Program. By doing so, the study aimed to provide insights into how these trends reflect broader changes in mental health treatment practices and policy implications within the Medicaid system during the study period.

Methods:

Public Medicaid data from 2017 to 2021 were analyzed, focusing on 30 FDA-approved antidepressants. Spending and prescription data were aggregated using Excel and Python.

Results:

The total US Medicaid expenditure on antidepressants increased from about $1 billion dollars in 2017 to $1.12 billion dollars in 2021, an increase of about 10%. Consistently, SSRIs were the class of antidepressants that Medicaid spent the most on. The highest Medicaid spending on a single antidepressant in 2017 and 2018 was bupropion. During the remaining years of the study (2019, 2020, 2021) Medicaid appropriated most funds toward Vortioxetine. The total number of antidepressant prescriptions increased from 52 million scripts to 59 million scripts (an increase of about 14%).

Conclusions:

The increase in Medicaid spending on antidepressants during the study period can be explained by an increase in utilization (a 14% increase in antidepressant prescriptions from 2017 to 2021), and a shift toward prescribing newer more costly antidepressants (like SSRIs and others) and away from prescribing older, less costly antidepressants like monoamine oxidase inhibitors (MAOIs) and tricyclic antidepressants (TCAs)."

01 Mar 2024·CNS & neurological disorders drug targets

Effects of Vortioxetine on Cognition and Fatigue in Patients with Multiple Sclerosis and Depression: A Case Series Study

Article

Author: Solana, Maria ; Brieva, Luis ; Nogueras, Lara ; Canudes, Marc ; Hervás, José Vicente ; Valcheva, Petya ; González-Mingot, Cristina ; Peralta, Silvia ; Gil-Sanchez, Anna

Introduction::

Vortioxetine is a multimodal antidepressant drug that has been reported to have a positive impact on cognition, social function, and fatigue. Nevertheless, it has not been widely studied. Our objective was to explore the effects of vortioxetine on these and other parameters in patients with multiple sclerosis (MS) and depression.

Patients and Methodology::

This observational case series study included patients with MS and depression who received treatment with vortioxetine for at least 6 months. The patient history of depression and depressive symptoms was assessed. A neuropsychiatric evaluation was carried out using different scales, both before and after treatment.

Results::

Of the 25 patients who enrolled in the study, 17 completed the treatment. Significant improvements were observed in health status (EQ-5D; p = 0.002), mood (Beck’s Depression Inventory, BDI-II; p = 0.006), anxiety (State-Trait Anxiety Inventory, STAI-State; p = 0.021, and STAI-Trait; p = 0.011), and in the general health test (Short Form Health Survey, SF-36) for the vitality (p = 0.028) and mental health (p = 0.025) domains of the patients who completed the treatment. However, no statistically significant differences were observed in the cognitive tests related to attention, information processing speed, or fatigue.

Conclusion::

In this population, vortioxetine treatment was effective in reducing the symptoms of depression and improving anxiety, vitality, and mental health. In contrast, it did not produce any improvement in cognition or fatigue but an increase in sample size would be necessary to confirm these results.

News (Medical) associated with Vortioxetine Hydrobromide

02 Aug 2024

·www.fiercepharma.com

Fierce Pharma Asia—Merck's surprise hiccup in China; Leqembi's slow ramp; Lawmakers' new biosecurity target

Merck's surprise Gardasil decline in China, Leqembi's regulatory setback in Europe, and several U.S. lawmakers' plan to target certain Chinese clinical trial sites made our news this week. Merck is trying to determine the reasons behind the surprise decline of Gardasil in China. Eisai and Biogen's Leqembi was rejected by European authorities amid a continued slow sales ramp. Lawmakers behind the BIOSECURE Act are trying to block drugmakers from working with certain Chinese clinical trial sites. And more.1. Merck mystified by sudden 'step down' in Gardasil sales in ChinaMerck’s Gardasil suddenly slowed down in China. The HPV vaccine franchise has been a big growth driver for Merck’s overall business, having recently helped the company surpass AstraZeneca to become the biggest global pharma in China by sales. And the company’s 9% stock price declined after the news spoke to the vaccine’s importance. Merck is working with its local partner Zhifei Biological Products to understand the situation, and it already has a few theories.2. Eisai, Biogen's Alzheimer's med Leqembi turned down in Europe—but analyst says it's merely a 'delay'Biogen retains biosimilars as Eisai-partnered Leqembi plows ahead amid business pivotEisai, Biogen show Leqembi provides added benefits over time as Alzheimer's showdown with Lilly heats upEisai and Biogen’s Leqembi continued its slow ramp, with second-quarter sales reaching $40 million, including $30 million from the U.S. The drug’s expansion efforts hit a snag as regulators at the European Medicines Agency declined to recommend the anti-amyloid drug, citing a “small” benefit and ARIA as a safety concern. Meanwhile, an extended study showed Leqembi’s benefit in cutting average cognitive declines appeared to widen to 31% over three years, compared with 27% in the original 18-month study.3. Congress targeting trials at Chinese military hospitals and in Xinjiang Uyghur Autonomous Region (Biocentury)The House Select Committee on the Chinese Communist Party, the driving force behind the draft BIOSECURE Act, has set its eyes on the next target in its crackdown against China. Lawmakers are looking for ways to block drugs seeking U.S. approvals from being tested at facilities associated with the Chinese army, including those that serve civilian patients, Biocentury reports, citing people familiar with the matter.4. With BIOSECURE Act looming, WuXi AppTec shows declining revenueAs the draft BIOSECURE Act threatens to push WuXi AppTec out of the U.S. market, the CRO giant’s business has so far remained relatively stable. The company’s U.S. sales, which accounted for 62% of the firm’s total, only fell by 1% in the first half of 2024. As the bill moves forward, WuXi spent $360,000 on lobbying efforts in the second quarter, more than tripling the $100,000 it spent in the fourth quarter of 2023.5. Takeda's Entyvio holds onto IBD market share despite threat from AbbVie's SkyriziTakeda takes $140M charge on failed epilepsy drug, while touting continued FDA potentialLundbeck leaves Trintellix to partner Takeda in the US, opting for royalties as it focuses efforts on RexultiDespite the entry of newer inflammatory bowel disease therapies such as AbbVie’s Skyrizi, Takeda’s Entyvio still grew sales by 7.6% during the three months ended in June, reaching $1.5 billion. The company took an impairment charge of about $143 million tied to the Ovid Therapeutics-partnered epilepsy med soticlestat’s recent phase 3 flop. Meanwhile, the Japanese pharma will take full U.S. control of depression drug Trintellix as its long-time partner Lundbeck wants to reallocate resources. The drug will lose U.S. patent protection at the end of 2026.6. Otsuka pays $800M for Jnana Therapeutics and its clinical-stage PKU drugThe dealmaking streak among Japanese pharmas continues. Otsuka is acquiring Jnana Therapeutics for $800 million, plus up to $325 million in milestones, to obtain a clinical-stage oral phenylketonuria (PKU) drug coded JNT-517, an allosteric small-molecule inhibitor of SLC6A19. A registrational study for the med is planned for next year.7. Kyowa Kirin looks to cut small molecule research and manufacturing jobs, slims down in AsiaKyowa Kirin is making some major adjustments to its business. The Japanese pharma is planning “a significant reduction” in small molecule research activities as it focuses on biologics. It’s also looking to trim some manufacturing jobs. In two separate deals, Kyowa will divest its Chinese operations to WinHealth Pharma and transfer rights to seven established brands in certain Asian markets to DKSH Holding.8. Instil refills pipeline in $2B biobucks deal with China's ImmuneOnco for 2 cancer assetsAfter Akeso and Summit Therapeutics’ positive readout for their PD-1xVEGF bispecific ivonescimab against Merck’s Keytruda in a Chinese phase 3 trial, Instil Bio has agreed to pay Shanghai biotech ImmuneOnco Biopharmaceuticals $50 million in upfront and near-term payments, plus up to $2 billion in potential milestones, for two assets, including a PD-L1xVEGF bispecific.Other News of Note:9. After tense standoff, AstraZeneca and Daiichi's Enhertu turned away by NICE on pricing grounds10. Chasing Pfizer and Lilly, Sun Pharma wins FDA nod for alopecia areata med Leqselvi11. South Korea regulator hits GSK for problems with asthma, acne drugs: report12. Ideaya, eyeing drug combos, bags option on Biocytogen bispecific ADC in $400M deal13. In Eisai, Medidata finds its first big buyer for new clinical trial management platform

Phase 3AcquisitionVaccine

09 May 2024

·www.biospace.com

Alto Neuroscience Announces Data Presentations Highlighting Late-Stage Clinical Pipeline and Robust Platform at Upcoming Scientific Conferences

– Breadth of Alto’s pipeline and Precision Psychiatry Platform™ will be highlighted across twelve posters and presentations at the Society of Biological Psychiatry and American Society of Clinical Psychopharmacology Annual Meetings – – Presented comprehensive identification and prospective replication of neurobiological markers linked to cognitive impairment associated with schizophrenia; Results inform design of planned ALTO-101 proof-of-concept study in CIAS – – Importance of developing ALTO-100 in depression characterized by poor cognition highlighted through new analyses demonstrating baseline cognition does not moderate response for vortioxetine and poor cognition in turn drives functional impairment in depression – LOS ALTOS, Calif.--(BUSINESS WIRE)-- Alto Neuroscience, Inc. (“Alto”) (NYSE: ANRO) today announced upcoming data presentations that highlight the company’s precision psychiatry pipeline and biomarker-based analyses at the Society of Biological Psychiatry (SOBP) and American Society of Clinical Psychopharmacology (ASCP) Annual Meetings, to take place May 9-11 in Austin, TX, and May 28-31 in Miami Beach, FL, respectively. “The vast amount of clinical and biomarker data we’ve generated to date enables our team to make important contributions to the scientific community and develop novel compounds for patients in need, in both depression and schizophrenia,” said Amit Etkin, M.D., Ph.D., founder and chief executive officer of Alto Neuroscience. “Alto’s precision psychiatry platform continues to get stronger with each new dataset we analyze. Importantly, we have systematically identified and prospectively replicated neurobiological markers linked to cognitive impairment associated with schizophrenia in a comprehensive analysis inclusive of all major candidate biomarkers. Our rigorous data science approach derives its impact from prospectively validating important discoveries. In this case, doing so enables us to identify the most pertinent and consistent signals to use as primary outcome measures for proof-of-concept studies – with theta response as a notable example of this in the planned ALTO-101 study.” Summary of Data Presentations Across Clinical Programs ALTO-100: Data from the completed Phase 2a study highlight the identification, and prospective replication, of a memory-based cognitive marker predicting greater antidepressant response to ALTO-100. New analysis of vortioxetine Phase 3 data demonstrates that baseline cognitive performance is not a moderator of response to vortioxetine. Vortioxetine does not show greater benefit in patients with poor baseline cognitive performance despite its reported benefits for aspects of cognition. New analysis of a large depression trial demonstrates that poor memory predicts worse functional outcomes in depression – further highlighting the need for better treatment options for this underserved population. ALTO-101: Data from a completed randomized, double-blind, placebo-controlled Phase 1 study in healthy adult volunteers demonstrate significant effects of ALTO-101 on electrophysiological measures relevant to cognitive processing, including theta response, as well as information processing speed, an important area of cognitive impairment associated with schizophrenia. A new analysis of the Bipolar and Schizophrenia Network for Intermediate Phenotypes (BSNIP) studies identified, and prospectively replicated, theta response as the EEG marker best linked to schizophrenia diagnosis and cognitive impairment in patients. A notable relationship between theta response and processing speed, which is thought to underpin cognitive impairment in schizophrenia, was observed. ALTO-300: Data from the completed Phase 2a study highlight the identification, and prospective replication, of an EEG-based cognitive marker predicting greater response to ALTO-300. The details of each presentation follow: Society of Biological Psychiatry Annual Meeting Thursday, May 9, 2024 Poster Session I: 5:30-7:30 p.m. CT, Griffin Hall Presentation Title: Identification and Prospective Replication of a Cognitive Biomarker for Predicting the Antidepressant Effect of ALTO-100, a Novel Pro-plasticity Drug Candidate, in Patients with Major Depression: Results from a Large Phase 2a Study Poster Authors: Joshua T. Jordan, Ph.D., Nicholas J. Cooper, Ph.D., Faizan Badami, M.S., Jessica Powell, Wei Wu, Ph.D., Amit Etkin, M.D., Ph.D., Adam J. Savitz, M.D., Ph.D. Presentation Title: Identification and Prospective Replication of Electrophysiological Markers Linked to Cognitive Impairment in Schizophrenia Poster Authors: Chao Wang, Ph.D., Sam Goncalves, M.S., Joshua T. Jordan, Ph.D., Maimon Rose, Ph.D., Akshay Sujatha Ravindran, Ph.D., Mike Avissar, M.D., Ph.D., Greg Hajcak, Ph.D., Faizan Badami, M.S., Yueqi Guo, Ph.D., Wei Wu, Ph.D., Jessica Powell, Amit Etkin, M.D., Ph.D., Adam J. Savitz, M.D., Ph.D. Presentation Title: Verbal Memory and Inhibitory Control Predict Functional Capacity in Major Depressive Disorder: A Secondary Analysis of the ReMIND SWITCH Trial Poster Authors: Joshua T. Jordan, Ph.D, Li Shen, Ph.D, Wei Wu, Ph.D., Adam J. Savitz, M.D., Ph.D., Amit Etkin, M.D., Ph.D. Friday, May 10, 2024 Concurrent Symposia: 4:00-6:00 p.m. CT, JW Grand Ballroom 2 Session Title: Bringing Precision Psychiatry out of the Lab and Into the Clinic: Developing Biomarkers for Diagnosis, Drug Development, Treatment Selection and Tracking Clinical Status Speakers: Amit Etkin, M.D., Ph.D., founder and CEO of Alto will serve as Chair, and Adam Savitz, M.D., Ph.D., CMO of Alto, will serve as Co-chair of the session. Additional presenters include Daniel Mathalon, M.D., Ph.D., University of California, San Francisco; Magali Haas, M.D., Ph.D., Cohen Veterans Bioscience; Katharine Dunlop, Ph.D., University of Toronto Dr. Etkin will present from 5:25-5:50 p.m. CT: Development and Prospective Replication of Biomarkers for Predicting Treatment Outcome With ALTO-100 and ALTO-300 in Major Depression: Data from Multiple Phase 2 Programs. Dr. Savitz will serve as a discussant for the panel. Poster Session II: 6:00-8:00 p.m. CT, Griffin Hall Presentation Title: Identification and Prospective Replication of an EEG Biomarker for Predicting the Antidepressant Effect of ALTO-300 in Patients with Major Depression: Results from a Large Phase 2a Study Poster Authors: Maimon Rose, Ph.D., Joshua T. Jordan, Ph.D., Chao Wang, Ph.D., Faizan Badami, M.S., Jessica Powell, Fadi Abdel, M.D., Wei Wu, Ph.D., Amit Etkin, M.D., Ph.D., Adam J. Savitz, M.D., Ph.D. Presentation Title: Baseline Cognition is Not Associated with Depression Outcomes with Vortioxetine for Major Depressive Disorder: Findings from Placebo-Controlled Trials Poster Authors: Joshua T. Jordan, Ph.D., Li Shen, Ph.D., Nicholas J. Cooper, Ph.D., Samantha V. Goncalves, M.S., Madhukar H. Trivedi, M.D., Alan F. Schatzberg, M.D., Wei Wu, Ph.D., Adam J. Savitz, M.D., Ph.D., & Amit Etkin, M.D., Ph.D. Saturday, May 11, 2024 Poster Session III: 5:00-7:00 p.m. CT, Griffin Hall Presentation Title: Identification of Brain/Behavior-based Pro-cognitive Pharmacodynamic Effects for ALTO-101 in Healthy Volunteers: Results from a Randomized, Double-blind Phase 1 Study Poster Authors: Akshay Ravindran, Ph.D., Guhan Sundar, Samantha Goncalves, M.S., Chao Wang, Ph.D., Li Shen, Maimon Rose, Ph.D., Joshua T. Jordan, Ph.D., Nicholas J. Cooper, Ph.D., Sebastian Marquez, Ph.D., Faizan Badami, M.S., Wei Wu, Ph.D., Amit Etkin, M.D., Ph.D., Adam J. Savitz, M.D., Ph.D. American Society of Clinical Psychopharmacology Annual Meeting Tuesday, May 28, 2024 Pharmaceutical Pipeline Session: 2:00-4:00 p.m. ET, Salon 3 Presentation Title: Pro-cognitive Pharmacodynamic Effects of ALTO-101: Results from Brain and Behavioral Outcomes in a Randomized, Double-blind Phase 1 Study Poster Authors: Akshay Ravindran, Ph.D., Guhan Sundar, Samantha Goncalves, M.S., Chao Wang, Ph.D., Li Shen, Ph.D., Maimon Rose, Ph.D., Joshua T. Jordan, Ph.D., Nicholas J. Cooper, Ph.D., Sebastian Marquez, Ph.D., Tabitha Carreira, MPH, Jessica Powell, Faizan Badami, M.S., Wei Wu, Ph.D., Amit Etkin, M.D., Ph.D., Adam J. Savitz, M.D., Ph.D. Workshop: 4:15-6:15 p.m. ET, Poinciana 3-4 Presentation Title: Good News/Bad News: Precision Neuroscience and the Clinical Trials Ecosystem Speakers: Mark Opler, Ph.D., M.P.H. (Chair); Adam Savitz, M.D., Ph.D., Alto Neuroscience; Seth C. Hopkins, Ph.D., Sumitomo Pharma America; John Carlos Diaz, GeoSera; John Sonnenberg, Ph.D., Uptown Research Institute; Barbara Echevarria, Ph.D., WCG; George Garibaldi, M.D., Garibaldi Consulting GMBH Wednesday, May 29, 2024 Individual Research Reports: 3:00-4:30 p.m. ET, Salon 2 Presentation Title: Baseline Cognition is not Associated with Depression Outcomes with Vortioxetine for Major Depressive Disorder: Findings from Placebo-controlled Trials Poster Authors: Joshua T. Jordan, Ph.D., Li Shen, Ph.D., Nicholas J. Cooper, Ph.D., Samantha V. Goncalves, M.S., Madhukar H. Trivedi, M.D., Alan F. Schatzberg, M.D., Wei Wu, Ph.D., Adam J. Savitz, M.D., Ph.D., & Amit Etkin, M.D., Ph.D. Thursday, May 30, 2024 Poster Session II: 12:30-2:15 p.m. ET, Salon 4 Presentation Title: A Biomarker-Based Enrichment Strategy for Neuropsychiatric Drug Development: Examples from Two Ongoing Phase 2b Studies Poster Authors: Michael Avissar, M.D., Ph.D., Joshua T. Jordan, Ph.D., Nicholas Cooper, Ph.D., Maimon Rose, Ph.D., Chao Wang, Ph.D., Faizan Badami, M.S., Peter Emmel, Kaitlly Zhu, Jessica Powell, Fadi Abdel, M.D., Amit Etkin, M.D., Ph.D., Adam J. Savitz, M.D., Ph.D. Presentation Title: Prevalence and Correlates of Cognitive Impairment in Depression: Findings from the Texas Resilience Against Depression Study Poster Authors: Joshua T. Jordan, Ph.D., Li Shen, Ph.D., Cherise Chin-Fatt, Ph.D., Adam J. Savitz, M.D., Ph.D., Amit Etkin, M.D., Ph.D., & Madhukar H. Trivedi, M.D. About Alto Neuroscience Alto Neuroscience is a clinical-stage biopharmaceutical company with a mission to redefine psychiatry by leveraging neurobiology to develop personalized and highly effective treatment options. Alto’s Precision Psychiatry Platform™ measures brain biomarkers by analyzing EEG activity, neurocognitive assessments, wearable data, and other factors to better identify which patients are more likely to respond to Alto product candidates. Alto’s clinical-stage pipeline includes novel drug candidates in depression, PTSD, schizophrenia, and other mental health conditions. For more information, visit or follow Alto on X. Forward Looking Statements This press release may contain forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These statements may be identified by words such as “aims,” “anticipates,” “believes,” “could,” “estimates,” “expects,” “forecasts,” “goal,” “intends,” “may,” “plans,” “possible,” “potential,” “seeks,” “will” and variations of these words or similar expressions that are intended to identify forward-looking statements, although not all forward-looking statements contain these words. Forward-looking statements in this press release include, but are not limited to, statements regarding Alto’s expectations for the timing, progress, and results of its studies. Actual results or events could differ materially from the plans, intentions and expectations disclosed in these forward-looking statements as a result of various factors, including uncertainties inherent in the initiation, progress and completion of Alto’s studies and other important factors, any of which could cause Alto’s actual results to differ from those contained in the forward-looking statements, which are described in greater detail in the section titled “Risk Factors” in Alto’s Annual Report on Form 10-K for the fiscal year ended December 31, 2023 filed with the Securities and Exchange Commission (“SEC”) as well as in other filings Alto may make with the SEC in the future. Any forward-looking statements contained in this press release speak only as of the date hereof, and Alto expressly disclaims any obligation to update any forward-looking statements contained herein, whether because of any new information, future events, changed circumstances or otherwise, except as required by law.

Phase 2Phase 1ASCOClinical Result

07 Mar 2024

·www.globenewswire.com

Neumora Therapeutics Reports Fourth Quarter and Full Year 2023 Financial Results and Provides Business Update

On-track to report topline Phase 3 data from the KOASTAL-1 study with navacaprant in MDD in the second half of 2024 and Phase 1 data with NMRA-266 in healthy adult participants mid-2024 Strong financial position with $463.8 million in cash, cash equivalents and marketable securities expected to support operations into 2026 WATERTOWN, Mass., March 07, 2024 (GLOBE NEWSWIRE) -- Neumora Therapeutics, Inc. (Nasdaq: NMRA), a clinical-stage biopharmaceutical company redefining neuroscience drug development, today announced financial results for the fourth quarter and full year ended December 31, 2023 and provided a business update. “2023 was a watershed year for Neumora as we transitioned to a publicly traded company, advanced our KOR antagonist, navacaprant, into three Phase 3 registrational studies, and brought our M4 PAM, NMRA-266, into the clinic ahead of schedule,” said Henry Gosebruch, chief executive officer, Neumora. “We have an exciting year ahead as we look forward to a data-rich 2024 including anticipated readouts from two clinically validated programs – our Phase 3 navacaprant program in major depressive disorder and Phase 1 data from our NMRA-266 program – and the initiation of several key clinical studies. Additionally, we continue to build on our leadership position in brain disorders with an industry-leading pipeline of seven clinical and preclinical programs all targeting novel mechanisms of action. We believe we are well on our way to redefine treatment options for people suffering from debilitating brain diseases.” KEY PIPELINE HIGHLIGHTS Neumora is advancing a therapeutic pipeline of seven clinical and preclinical neuroscience programs that target novel mechanisms of action for a broad range of underserved neuropsychiatric disorders and neurodegenerative diseases. Navacaprant (NMRA-140): Phase 3 KOASTAL Program On-Track with Major Depressive Disorder (MDD) Data Expected in 2024Navacaprant (NMRA-140) is a highly selective, novel, once-daily kappa opioid receptor (KOR) antagonist being developed as a potential monotherapy treatment for MDD and other neuropsychiatric disorders. The KOR antagonist approach has been clinically validated in three independent studies. Neumora is currently enrolling the registrational Phase 3 KOASTAL program, which is designed to evaluate the efficacy and safety of navacaprant monotherapy for the treatment of MDD. KOASTAL-1, KOASTAL-2, and KOASTAL-3 are replicate Phase 3, randomized, placebo-controlled, double-blind studies in adult patients with MDD. In February 2024 following a Type D meeting, the U.S. Food and Drug Administration (FDA) provided written feedback that there is no need for the Company to conduct further studies to assess physical dependence with navacaprant. Navacaprant did not demonstrate properties associated with risks of opioid-related abuse in several mode of action profiling studies. Data from these studies were presented at the Annual Meeting of the Society of Biological Psychiatry and College on Problems of Drug Dependence Annual Meeting in 2023. Neumora expects to report topline data from the KOASTAL-1 study in the second half of 2024, and topline data from the KOASTAL-2 and KOASTAL-3 studies in the first half of 2025. Neumora also intends to evaluate the potential of navacaprant as treatment for other neuropsychiatric populations beyond MDD, including bipolar depression (BPD). The Company expects to initiate a Phase 2 clinical trial in BPD in the first half of 2024. NMRA-266: Phase 1 Study Underway with Data in Healthy Adult Participants Expected mid-2024NMRA-266 is a highly selective positive allosteric modulator (PAM) of the M4 muscarinic receptor that Neumora is developing as a treatment for schizophrenia and other neuropsychiatric disorders. Neumora expects to report data from a Phase 1 single ascending dose / multiple ascending dose study evaluating NMRA-266 in healthy adult participants in mid-2024.Additionally, Neumora expects to initiate a Phase 1b study in schizophrenia in the second half of 2024, with data from that study anticipated in 2025. NMRA-511: Phase 1b Study in Alzheimer’s Disease Agitation Planned NMRA-511 is an antagonist of the vasopressin 1a receptor (V1aR), with high selectivity over V1b, V2 (greater than 3,000-fold) and oxytocin receptors (approximately 300-fold). Vasopressin plays a role in the regulation of aggression, affiliation, stress and anxiety response. Neumora expects to initiate a Phase 1b study in Alzheimer's disease agitation in the first half of 2024, with data from that study anticipated in 2025. BUSINESS UPDATES Announced Key Leadership Appointments In October 2023, Neumora announced that Robert Lenz, M.D., Ph.D., had joined Neumora as executive vice president, head of R&D. Dr. Lenz brings more than two decades of neuroscience drug development expertise, most recently serving as senior vice president and head of global development at Amgen.In December 2023, Neumora announced the appointment of Jason Duncan as Chief Legal Officer. Mr. Duncan brings more than two decades of legal, compliance, development and operations experience in the life sciences industry.In January 2024, Neumora announced the appointment of Kaya Pai Panandiker as Chief Commercial Officer. Ms. Pai Panandiker brings more than 20 years of experience commercializing medicines in areas of significant unmet need, including the commercial launches of blockbuster products, TRINTELLIX® (vortioxetine) and REXULTI® (brexpiprazole) for MDD and schizophrenia. FOURTH QUARTER AND FULL YEAR FINANCIAL RESULTS Cash Position: As of December 31, 2023, Neumora had cash, cash equivalents and marketable securities of $463.8 million.Financial Guidance: The Company expects that its cash, cash equivalents and marketable securities as of December 31, 2023, will enable it to fund its operating plan into 2026.R&D Expense: Research and development expenses for the fourth quarter of 2023 were $38.9 million, as compared to $23.5 million for the same period in 2022. Research and development expenses for the full year ended December 31, 2023 were $142.7 million, compared to $91.7 million for the same period in 2022. This increase was primarily due to advancement of clinical and preclinical programs and related start-up activities for Phase 3 clinical trials evaluating navacaprant as a monotherapy treatment for MDD. Additionally, full year 2023 results include $63.9 million of primarily non-cash acquired in-process research and development costs (IPR&D) and full year 2022 results include $13.0 million of acquired IPR&D costs related to milestone payments from our collaborations.G&A Expense: General and administrative expenses for the fourth quarter of 2023 were $11.2 million, as compared to $7.2 million for the same period in 2022. General and administrative expenses for the full year ended December 31, 2023, were $45.5 million, as compared to $31.1 million for the same period in 2022. This increase was primarily due to personnel-related costs, including stock-based compensation and professional services to support the continued expansion of administrative functions.Net Loss: The Company reported a net loss of $108.7 million for the fourth quarter of 2023, as compared to $28.1 million for the same period in 2022. Neumora reported a net loss of $235.9 million for the full year ended December 31, 2023, as compared to $130.9 million for the same period in 2022. About NeumoraNeumora Therapeutics, Inc. is a clinical-stage biopharmaceutical company founded to confront the global brain disease crisis by taking a fundamentally different approach to the way treatments for brain diseases are developed. Our therapeutic pipeline currently consists of seven clinical and preclinical neuroscience programs that target novel mechanisms of action for a broad range of underserved neuropsychiatric disorders and neurodegenerative diseases. Our work is supported by an integrated suite of translational, clinical, and computational tools to generate insights that can enable precision medicine approaches. Neumora’s mission is to redefine neuroscience drug development by bringing forward the next generation of novel therapies that offer improved treatment outcomes and quality of life for patients suffering from brain diseases. Cautionary Note Regarding Forward-Looking StatementsThis press release contains forward-looking statements about Neumora Therapeutics, Inc. (the “Company,” “we,” “us,” or “our”) within the meaning of the federal securities laws, including statements related to: Neumora’s intention to redefine neuroscience drug development by bringing forward the next generation of novel therapies that offer improved treatment outcomes and quality of life for patients suffering from brain diseases; the timing, progress and plans for its therapeutic development programs, including the timing of initiation and data read outs for its programs and studies, as well as its clinical trial and development plans; timing and expectations related to regulatory filings and interactions; expectations and projections regarding future operating results and financial performance, including the sufficiency of its cash resources and expectation of the timing of its cash runway; its ability to create significant value and; other statements identified by words such as “could,” “expects,” “intends,” “may,” “plans,” “potential,” “should,” “will,” “would,” or similar expressions and the negatives of those terms. Other than statements of historical facts, all statements contained in this press release, are forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. These statements are subject to risks and uncertainties that could cause the actual results or to be materially different from the information expressed or implied by these forward-looking statements, including, among others: the risks related to the inherent uncertainty of clinical drug development and unpredictability and lengthy process for obtaining regulatory approvals; risks related to the timely initiation and enrollment in our clinical trials; risks related to our reliance on third parties, including CROs; risks related to serious or undesirable side effects of our therapeutic candidates; risks related to our ability to utilize and protect our intellectual property rights; and other matters that could affect sufficiency of capital resources to fund operations. For a detailed discussion of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to Neumora’s business in general, please refer to the risk factors identified in the Company’s filings with the Securities and Exchange Commission (SEC), including but not limited to its Registration Statement on Form S-1, as amended (File No. 333-274229), filed with the SEC on September 11, 2023, and related Prospectus dated September 14, 2023 filed under 424(b)(4) of the Securities Act of 1933, as amended. Forward-looking statements speak only as of the date hereof, and, except as required by law, Neumora undertakes no obligation to update or revise these forward-looking statements. Financial Tables NEUMORA THERAPEUTICS, INC.Unaudited Consolidated Statements of Operations and Comprehensive Loss(In thousands, except share and per share amounts) Three months ended December 31, Year ended December 31, 2023 2022 2023 2022 Operating expenses: Research and development $38,864 $23,523 $142,719 $91,749 Acquired in-process research and development 63,904 — 63,904 13,000 General and administrative 11,236 7,195 45,475 31,121 Total operating expenses 114,004 30,718 252,098 135,870 Loss from operations (114,004) (30,718) (252,098) (135,870)Other income (expense): Interest income 5,646 2,285 16,611 4,561 Other income (expense), net (104) 287 (170) 405 Total other income 5,542 2,572 16,441 4,966 Net loss before income taxes (108,462) (28,146) (235,657) (130,904)Provision for income taxes 268 — 268 — Net loss (108,730) (28,146) (235,925) (130,904)Other comprehensive income (loss): Unrealized gain (loss) on marketable securities 235 380 698 (774)Comprehensive loss $(108,495) $(27,766) $(235,227) $(131,678)Net loss per share, basic and diluted $(0.71) $(0.99) $(3.63) $(4.81)Weighted-average shares outstanding, basic and diluted 152,832 28,293 65,021 27,207 Unaudited Condensed Consolidated Balance Sheets(in thousands) December 31, 2023 December 31, 2022Cash, cash equivalents and marketable securities $463,827 $395,395 Total assets 496,195 426,234 Total liabilities 27,119 29,397 Total stockholders’ equity (deficit) 469,076 (446,850) Neumora ContactHelen Rubinstein+1 (315) 382-3979Helen.Rubinstein@neumoratx.com

Phase 1Phase 3Financial StatementPhase 2Executive Change

100 Deals associated with Vortioxetine Hydrobromide

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KEGG	Wiki	ATC	Drug Bank
D10185	Vortioxetine Hydrobromide	N06AX26	DB09068

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Depressive Disorder	CN	H. Lundbeck A/S	21 Nov 2017
Depressive Disorder, Major	US	Takeda Pharmaceuticals U.S.A., Inc.	30 Sep 2013

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Depression	Phase 3	US	H. Lundbeck A/S	10 Aug 2021
Depression	Phase 3	CO	H. Lundbeck A/S	10 Aug 2021
Depression	Phase 3	LV	H. Lundbeck A/S	10 Aug 2021
Depression	Phase 3	MX	H. Lundbeck A/S	10 Aug 2021
Depression	Phase 3	PL	H. Lundbeck A/S	10 Aug 2021
Depression	Phase 3	RU	H. Lundbeck A/S	10 Aug 2021
Depression	Phase 3	UA	H. Lundbeck A/S	10 Aug 2021
Brain Injuries, Traumatic	Phase 3	-	Takeda Pharmaceutical Co., Ltd.	01 Oct 2016
Cognitive Dysfunction	Phase 3	-	H. Lundbeck A/S	01 Dec 2011
Major depressive disorder, moderate (MDD)	Phase 3	-	H. Lundbeck A/S	01 Dec 2011

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04288895 (NCT04288895, Pubmed \| Curr Med Res Opin)	Phase 4	Depressive Disorder, Major	395	Vortioxetine 5-20 mg/day	jctysktqvu(fbtulpuwki) = 35.4% (n = 140) of patients experienced treatment-emergent AEs (mostly mild-moderate); nausea and pruritus were the most frequent (6.6%, n = 26 each) tsxhfinxuw (fwwrymlsre )	Positive	07 Aug 2024
NCT04448431 (Pubmed)	Phase 4	Depressive Disorder, Major	605	Vortioxetine	njvrbyxzky(ectuigamsa) = TEAEs were reported in 46.1% and 39.6% of patients in the vortioxetine and desvenlafaxine groups, respectively; these were mostly mild or moderate in intensity (> 98% of all TEAEs in each group) znbdkdeyov (qdhyysucdq )	-	22 May 2023
NCT05014919 (CTgov)	Phase 3	Depressive Disorder, Major \| Depression	35	Vortioxetine (Double-Blind Relapse Prevention: Vortioxetine)	lkbggnzyod(ztdbxizkjc) = lzrvnfsbks yepslitkvj (uowaugfbsi, mfjrwqlded - xlfjdepaef) View more	-	05 Jan 2023
NCT05014919 (CTgov)	Phase 3	Depressive Disorder, Major \| Depression	35	placebo (Double-Blind Relapse Prevention: Placebo)	lkbggnzyod(ztdbxizkjc) = visrsvbgqk yepslitkvj (uowaugfbsi, vaqkpryqoa - zfdzjvkild) View more	-	05 Jan 2023
NCT02871297 (CTgov)	Phase 3	Depressive Disorder, Major	662	Vortioxetine	nocdcnpqiv(enjbprrlgk) = zelnskpzbw pdkhazrvnk (iuaozkdvvh, bmsipyowfb - lamdscjmnm) View more	-	28 Dec 2022
NCT03555136 (RELIEVE, Pubmed)	Not Applicable	Depressive Disorder, Major \| Generalized anxiety disorder	180	Vortioxetine	eqtggawbny(rnyagnazpd) = dwnvgbhcpm hpzwfzexuq (dtkklboqnv ) View more	Positive	15 Nov 2022
NCT02709655 (CTgov)	Phase 3	Depressive Disorder, Major	683	placebo (Double-Blind: Placebo)	vshopggetq(ntxsjqfybt) = rjjqcyijui kqhcmlrofu (pvqbwzoxmu, elrsgazrep - paqvaylvkg) View more	-	22 Sep 2022
NCT02709655 (CTgov)	Phase 3	Depressive Disorder, Major	683	Vortioxetine (Double-Blind: Vortioxetine 10 mg)	vshopggetq(ntxsjqfybt) = glblkebamk kqhcmlrofu (pvqbwzoxmu, cvktaqzjop - sepomkfgpr) View more	-	22 Sep 2022
NCT03555136 (RELIEVE, Pubmed) Manual	Not Applicable	Depressive Disorder, Major	184	Vortioxetine Hydrobromide	rudqeylnpt(rwtduyotgj) = mihiyrusbq phkkedqrbv (qygnouzutl ) View more	Positive	31 Aug 2022
NCT03555136 (RELIEVE, Pubmed) Manual	Not Applicable	Depressive Disorder, Major	231	Vortioxetine Hydrobromide	gmrnjadxeh(sbvcxodate) = momdpetpku gpejgjacyw (azcuwtbnta ) View more	Positive	09 Aug 2022
NCT02371980 (RESET, Pubmed \| J Affect Disord)	Phase 4	Depressive Disorder, Major Maintenance	1,106	Vortioxetine 5 mg	srhpcfucds(fhlyumdwhp) = zzfavvyngh tslzijrvbp (qwwtgnwrsi )	Positive	04 Feb 2022
NCT02371980 (RESET, Pubmed \| J Affect Disord)	Phase 4	Depressive Disorder, Major Maintenance	1,106	Vortioxetine 10 mg	srhpcfucds(fhlyumdwhp) = wmticackmb tslzijrvbp (qwwtgnwrsi )	Positive	04 Feb 2022
NCT02972632 (Pubmed \| BMC Psychiatry) Manual	Phase 4	Depressive Disorder, Major	122	vortioxetine	wqcifgguff(ajqkoyvggu) = lnazuybmhk wrsfpyjibo (blykycfhzq ) View more	Positive	11 Dec 2021

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