Identification, Assessment, and Treatment of Tardive Dyskinesia With Valbenazine in Adults With Intellectual/Developmental Disabilities and Co-occurring Psychiatric and/or Behavioral Disorders

The goal of this open-label clinical trial is to test the safety and efficacy of valbenazine treatment in patients with Intellectual/Developmental Disability (IDD) who have a diagnosis of Tardive dyskinesia (TD). The main questions this study aims to answer are:
Does valbenazine treatment of TD in the previously untreated patient population of adults with IDD produce comparable amelioration of signs of movement disorder as what has historically been reported in adults without IDD?
Is valbenazine treatment of TD in persons with IDD as safe as what has historically been reported in adults without IDD?
Does valbenazine treatment improve Quality of Life (QOL) in persons with IDD and TD treated with valbenazine?
Does valbenazine treatment produce positive change in Activities of Daily Living (ADLs) in persons with IDD and TD?
Does valbenazine treatment of TD in persons with IDD reduce caregiver burden?
In this study, 25 participants with IDD and TD will undergo valbenazine treatment for 24 weeks. The participants will be seen for a total of 5 visits: at baseline, and at follow up visits at 3 weeks, 6 weeks, 12 weeks, and 24 weeks.
This study does not include a comparison group. Therefore, researchers will compare the response of the study participants to valbenazine treatment with those from a previous reported work that resulted in the FDA approval of this medication.

Start Date01 Aug 2024

Sponsor / Collaborator

Neurocrine Biosciences, Inc.

NCT06312189 / Enrolling by invitationPhase 3

Open-Label Study of Valbenazine for the Treatment of Chorea Associated With Huntington Disease in Canada

This study will evaluate long-term safety and tolerability of valbenazine in participants with chorea associated with Huntington Disease (HD) who participated in Study NBI-98854-HD3006 (NCT04400331) in Canada.

Start Date24 Apr 2024

Sponsor / Collaborator

Neurocrine Biosciences, Inc.

NCT05053321 / Not yet recruitingPhase 1IIT

Reduction of Demoralization After Treatment of TD With Valbenazine

The purpose of this research project is to determine the feasibility of a larger study aimed at demonstrating that treatment of tardive dyskinesia with Valbenazine is associated with reduction of demoralization

Start Date01 Apr 2024

Sponsor / Collaborator

Yale University

[+1]

100 Clinical Results associated with Valbenazine Tosylate

100 Translational Medicine associated with Valbenazine Tosylate

100 Patents (Medical) associated with Valbenazine Tosylate

109

Literatures (Medical) associated with Valbenazine Tosylate

01 Dec 2023·Biomedicine & pharmacotherapy = Biomedecine & pharmacotherapie

Oleanolic acid alleviates the extrapyramidal symptoms and cognitive impairment induced by haloperidol through the striatal PKA signaling pathway in mice

Article

Author: Jung, Seo Yun ; Min, Ji Won ; Kang, Woo Chang ; Lee, Jae Yeol ; Kim, Do Yeon ; Ryu, Jong Hoon ; Park, Keontae ; Cho, Kyungnam ; Kong, Chang Hyeon ; Kim, Jae Youn ; Jeon, Mijin

Haloperidol, one of the representative typical antipsychotics, is on the market for schizophrenia but shows severe adverse effects such as extrapyramidal symptoms (EPS) or cognitive impairments. Oleanolic acid (OA) is known to be effective for tardive dyskinesia which is induced by long-term treatment with L-DOPA. This study aimed to investigate whether OA could ameliorate EPS or cognitive impairment induced by haloperidol. The balance beam, catalepsy response, rotarod and vacuous chewing movement (VCM) tests were performed to measure EPS and the novel object recognition test was used to estimate haloperidol-induced cognitive impairment. Levels of dopamine and acetylcholine, the phosphorylation levels of c-AMP-dependent protein kinase A (PKA) and its downstream signaling molecules were measured in the striatum. OA significantly attenuated EPS and cognitive impairment induced by haloperidol without affecting its antipsychotic properties. Valbenazine only ameliorated VCM. Also, OA normalised the levels of dopamine and acetylcholine in the striatum which were increased by haloperidol. Furthermore, the increased phosphorylated PKA, extracellular signal-regulated kinase (ERK) and cAMP response element-binding protein (CREB) levels and c-FOS expression level induced by haloperidol were significantly decreased by OA in the striatum. In addition, cataleptic behaviour of haloperidol was reversed by sub-effective dose of H-89 with OA. These results suggest that OA can alleviate EPS and cognitive impairment induced by antipsychotics without interfering with antipsychotic properties via regulating neurotransmitter levels and the PKA signaling pathway in the striatum. Therefore, OA is a potential candidate for treating EPS and cognitive impairment induced by antipsychotics.

01 Nov 2023·International clinical psychopharmacology

Valbenazine for tardive dyskinesia: a systematic review and network meta-analysis.

Article

Author: Kishi, Taro ; Iwata, Nakao ; Sakuma, Kenji

To date, the role of valbenazine (VAL) in a dose-dependent increase in efficacy for tardive dyskinesia (TD) and in the worsening of acceptability and tolerability in a dose-dependent manner remains to be elucidated. Thus, in this systematic review and frequentist network meta-analysis, we compared 16 outcomes of VAL80 mg/d (VAL80) with VAL40 mg/d (VAL40) related to the efficacy, acceptability, tolerability, and safety in the treatment of patients with TD. Using a 95% confidence interval, we calculated the standardized mean difference for continuous variables and the risk ratio for dichotomous variables. Our results demonstrated that both VAL80 and VAL40 were superior to the placebo in terms of Abnormal Involuntary Movement Scale (AIMS) total score, Clinical Global Impression of Change-TD, and response to treatment, but VAL80 outperformed VAL40 in terms of AIMS score and response to treatment. However, any active therapy and placebo treatment groups did not have significant differences in acceptability, tolerability, and safety outcomes and similarly between VAL80 and VAL40 in any other outcomes. In conclusions, VAL could be increased from VAL40 to VAL80 if a patient with TD adequately tolerates VAL40 but treatment response is poor.

01 Nov 2023·Chirality

Valbenazine isomers and enantiomer determination by chiral normal phase liquid chromatography.

Article

Author: Deshpande, Girish K ; Akshinthala, Parameswari ; Deshmukh, Balasaheb R ; Kowtharapu, Leela Prasad ; Katari, Naresh Kumar ; Battula, Sreenivas Rao ; Gundla, Rambabu

A novel, simple, specific, rapid, enantioselective normal phase chiral high-performance liquid chromatographic method with amylose-based Chiral Pak IG-3(250 × 4.6 mM) 3.0 μM column was developed and validated for separation and quantification of isomers and enantiomer of Valbenazine. The mobile phase composed of n-Heptane, isopropyl alcohol, dichloromethane, ethanol, and diethylamine in the ratio of 70:10:15:5:0.1 (V/V/V/VV) with a gradient flow rate was applied. The injection volume was 10 μl, and detection was carried out using a photodiode array detector at 282 nM. The column compartment was set at 35°C. The resolution between the enantiomer and isomers was found to be more than 2.0. The method was linear over the concentration range of limit of quantitation to 250% for isomers and enantiomers. The method was found to be robust with column temperature. The proposed chiral method is applicable for the determination of isomers and enantiomer of Valibenazine and was successfully used in the quality control of bulk drug manufacturing and pharmaceuticals.

105

News (Medical) associated with Valbenazine Tosylate

01 Jun 2024

·www.biospace.com

Teva Presents First Real-World Data from the IMPACT-TD Registry Study at Psych Congress Elevate 2024

Nearly 98% of patients experience quality of life impact as a result of tardive dyskinesia (TD) including social, psychological, physical and recreational aspects of daily living Data highlight for the first time that TD has a multidimensional impact on patients including those with mild TD severity IMPACT-TD Registry is the largest-ever study of its kind evaluating the holistic effects of TD over three years along with real-world treatment patterns and outcomes with once-daily AUSTEDO® XR (deutetrabenazine) extended-release tablets and twice-daily AUSTEDO® (deutetrabenazine) tablets TEL AVIV, Israel & PARSIPPANY, N.J.--(BUSINESS WIRE)-- Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), today announced new patient- and physician-reported interim results from the Phase 4 IMPACT-TD Registry study, reinforcing that TD has a wide-reaching, multidimensional impact on patients’ quality of life. These interim findings from the IMPACT-TD study were presented at the 2024 Psych Congress Elevate Annual Meeting, taking place from May 30 – June 2 in Las Vegas, Nevada. “TD can be a devastating setback for those who have achieved mental stability with their psychiatric medication,” said Eric Hughes, MD, PhD, Executive Vice President of Global R&D and Chief Medical Officer at Teva. “These interim findings from IMPACT-TD Registry, the largest study of its kind, reveal the profound effect that TD can have on a patient’s life, beyond the clinic. Understanding the full impact of TD and how approved treatment options for TD, like once-daily AUSTEDO XR and twice-daily AUSTEDO, can help treat the condition is critical to improving outcomes for patients and is a driving force in our unwavering commitment to developing meaningful solutions for them.” The two-part IMPACT-TD study is a 3-year longitudinal observational study evaluating how TD progresses over time and impacts a patient’s quality of life (Part A), as well as outcomes related to treatment with once-daily AUSTEDO XR and twice-daily AUSTEDO (Part B). Clinician-reported TD severity and impact is assessed using the IMPACT-TD scale, the AIMS (Abnormal Involuntary Movement Scale) and the CGIS-TD (Clinical Global Impression of Severity of TD) scale. The interim analysis includes 286 patients with varying levels of TD severity and highlights, for the first time, that clinicians reported that TD has a multidimensional impact, even on patients with mild TD severity. Clinician-reported IMPACT-TD findings show: 98% of patients experience the impact of TD in some aspect of their quality of life 83% of patients experience moderate to severe impact across various quality of life domains, including social (59%), psychological/psychiatric (70%), physical (53%) and vocational/educational/recreational (57%) 54% and 61% of patients with “very mild” and “mild” TD severity based on CGIS-TD, respectively, experience moderate to severe impact on their quality of life Patient-reported TD impact is assessed using the novel IMPACT-TD PRO (IMPACT-TD Patient-Reported Outcome) scale. Patient-reported findings, as assessed with the IMPACT-TD PRO, show: 59% and 57% of patients reported that TD caused embarrassment in social situations and impacted their ability to enjoy the things they do for fun, respectively 43% of patients reported that TD impacts their sleep 38-42% of patients reported experiencing the physical impact of TD, including on their ability to hold things, do chores and exercise “These data provide a clearer understanding as to how the abnormal movements of TD significantly impact the daily functioning of patients that cannot be gleaned from looking solely at the severity of the movements,” said Richard Jackson, MD, an Assistant Clinical Adjunct Professor in the University of Michigan School of Medicine’s Department of Psychiatry and the study’s lead investigator. “TD can impact all domains of daily functioning including social, psychological, physical, occupational and recreational aspects of daily living even when the abnormal movements appear to be mild. This emphasizes the need for all clinicians to assess not only the severity of a patient’s TD movements but the impact those movements can have on all aspects of life. Continuing to understand the multifaceted impact of TD and finding ways to alleviate these burdens is crucial to supporting patients on their TD journey.” Also presented at Psych Congress Elevate 2024 were data supporting: The development and internal validation of the IMPACT-TD PRO scale, suggesting that the questionnaire can effectively and reliably characterize the multidimensional impact of TD in adult patients. Final results from the TD cohort of the Phase 4 START study, which investigated real-world treatment outcomes for patients starting AUSTEDO with the 4-week Titration Kit. These full START results show that the titration kit successfully helped patients with TD find individualized therapeutic AUSTEDO doses with effectiveness similar to that observed in the pivotal clinical trials, with high adherence and patient satisfaction rates. Findings from a retrospective study comparing healthcare resource utilization (HCRU) in patients with TD treated with benztropine versus non-treated patients with TD suggest that benztropine can result in potential harm and increased cost for the patient if used off-label for the treatment of TD. About Tardive Dyskinesia (TD) Tardive dyskinesia (TD) is a highly debilitating, chronic movement disorder that affects one in four people who take certain mental health treatments and is characterized by uncontrollable, abnormal, and repetitive movements of the face, torso, and/or other body parts, which may be disruptive and negatively impact individuals.1,2,3 About AUSTEDO XR Extended-Release Tablets and AUSTEDO Tablets AUSTEDO XR and AUSTEDO are the first vesicular monoamine transporter 2 (VMAT2) inhibitors approved by the U.S. Food and Drug Administration in adults for the treatment of tardive dyskinesia and for the treatment of chorea associated with Huntington’s disease. Safety and effectiveness in pediatric patients have not been established. AUSTEDO XR is the once-daily formulation of AUSTEDO. INDICATIONS AND USAGE AUSTEDO XR (deutetrabenazine) extended-release tablets and AUSTEDO (deutetrabenazine) tablets are indicated in adults for the treatment of chorea associated with Huntington’s disease and for the treatment of tardive dyskinesia. IMPORTANT SAFETY INFORMATION Depression and Suicidality in Patients with Huntington’s Disease: AUSTEDO XR and AUSTEDO can increase the risk of depression and suicidal thoughts and behavior (suicidality) in patients with Huntington’s disease. Balance the risks of depression and suicidality with the clinical need for treatment of chorea. Closely monitor patients for the emergence or worsening of depression, suicidality, or unusual changes in behavior. Inform patients, their caregivers, and families of the risk of depression and suicidality and instruct them to report behaviors of concern promptly to the treating physician. Exercise caution when treating patients with a history of depression or prior suicide attempts or ideation. AUSTEDO XR and AUSTEDO are contraindicated in patients who are suicidal, and in patients with untreated or inadequately treated depression. Contraindications: AUSTEDO XR and AUSTEDO are contraindicated in patients with Huntington’s disease who are suicidal, or have untreated or inadequately treated depression. AUSTEDO XR and AUSTEDO are also contraindicated in: patients with hepatic impairment; patients taking reserpine or within 20 days of discontinuing reserpine; patients taking monoamine oxidase inhibitors (MAOIs), or within 14 days of discontinuing MAOI therapy; and patients taking tetrabenazine or valbenazine. Clinical Worsening and Adverse Events in Patients with Huntington’s Disease: AUSTEDO XR and AUSTEDO may cause a worsening in mood, cognition, rigidity, and functional capacity. Prescribers should periodically re-evaluate the need for AUSTEDO XR or AUSTEDO in their patients by assessing the effect on chorea and possible adverse effects. QTc Prolongation: AUSTEDO XR and AUSTEDO may prolong the QT interval, but the degree of QT prolongation is not clinically significant when AUSTEDO XR or AUSTEDO is administered within the recommended dosage range. AUSTEDO XR and AUSTEDO should be avoided in patients with congenital long QT syndrome and in patients with a history of cardiac arrhythmias. Neuroleptic Malignant Syndrome (NMS), a potentially fatal symptom complex reported in association with drugs that reduce dopaminergic transmission, has been observed in patients receiving tetrabenazine. The risk may be increased by concomitant use of dopamine antagonists or antipsychotics. The management of NMS should include immediate discontinuation of AUSTEDO XR and AUSTEDO; intensive symptomatic treatment and medical monitoring; and treatment of any concomitant serious medical problems. Akathisia, Agitation, and Restlessness: AUSTEDO XR and AUSTEDO may increase the risk of akathisia, agitation, and restlessness. The risk of akathisia may be increased by concomitant use of dopamine antagonists or antipsychotics. If a patient develops akathisia, the AUSTEDO XR or AUSTEDO dose should be reduced; some patients may require discontinuation of therapy. Parkinsonism: AUSTEDO XR and AUSTEDO may cause parkinsonism in patients with Huntington’s disease or tardive dyskinesia. Parkinsonism has also been observed with other VMAT2 inhibitors. The risk of parkinsonism may be increased by concomitant use of dopamine antagonists or antipsychotics. If a patient develops parkinsonism, the AUSTEDO XR or AUSTEDO dose should be reduced; some patients may require discontinuation of therapy. Sedation and Somnolence: Sedation is a common dose-limiting adverse reaction of AUSTEDO XR and AUSTEDO. Patients should not perform activities requiring mental alertness, such as operating a motor vehicle or hazardous machinery, until they are on a maintenance dose of AUSTEDO XR or AUSTEDO and know how the drug affects them. Concomitant use of alcohol or other sedating drugs may have additive effects and worsen sedation and somnolence. Hyperprolactinemia: Tetrabenazine elevates serum prolactin concentrations in humans. If there is a clinical suspicion of symptomatic hyperprolactinemia, appropriate laboratory testing should be done and consideration should be given to discontinuation of AUSTEDO XR and AUSTEDO. Binding to Melanin-Containing Tissues: Deutetrabenazine or its metabolites bind to melanin-containing tissues and could accumulate in these tissues over time. Prescribers should be aware of the possibility of long-term ophthalmologic effects. Common Adverse Reactions: The most common adverse reactions for AUSTEDO (>8% and greater than placebo) in a controlled clinical study in patients with Huntington’s disease were somnolence, diarrhea, dry mouth, and fatigue. The most common adverse reactions for AUSTEDO (4% and greater than placebo) in controlled clinical studies in patients with tardive dyskinesia were nasopharyngitis and insomnia. Adverse reactions with AUSTEDO XR extended-release tablets are expected to be similar to AUSTEDO tablets. Please see accompanying full Prescribing Information, including Boxed Warning. About Teva Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) is a global pharmaceutical leader with a category-defying portfolio, harnessing our generics expertise and stepping up innovation to continue the momentum behind the discovery, delivery, and expanded development of modern medicine. For over 120 years, Teva's commitment to bettering health has never wavered. Today, the company’s global network of capabilities enables its ~37,000 employees across 58 markets to push the boundaries of scientific innovation and deliver quality medicines to help improve health outcomes of millions of patients every day. To learn more about how Teva is all in for better health, visit . Cautionary Note Regarding Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, which are based on management’s current beliefs and expectations and are subject to substantial risks and uncertainties, both known and unknown, that could cause our future results, performance or achievements to differ significantly from that expressed or implied by such forward-looking statements. You can identify these forward-looking statements by the use of words such as “should,” “expect,” “anticipate,” “estimate,” “target,” “may,” “project,” “guidance,” “intend,” “plan,” “believe” and other words and terms of similar meaning and expression in connection with any discussion of future operating or financial performance. Important factors that could cause or contribute to such differences include risks relating to: our ability to successfully develop and commercialize AUSTEDO and AUSTEDO XR for the treatment of tardive dyskinesia and for the treatment of chorea associated with Huntington’s disease; our ability to successfully compete in the marketplace, including our ability to develop and commercialize additional pharmaceutical products; our ability to successfully execute our Pivot to Growth strategy, including to expand our innovative and biosimilar medicines pipeline and profitably commercialize the innovative medicines and biosimilar portfolio, whether organically or through business development, and to sustain and focus our portfolio of generics medicines; and other factors discussed in our Quarterly Report on Form 10-Q for the first quarter of 2024 and in our Annual Report on Form 10-K for the year ended December 31, 2023, including in the section captioned “Risk Factors.” Forward-looking statements speak only as of the date on which they are made, and we assume no obligation to update or revise any forward-looking statements or other information contained herein, whether as a result of new information, future events or otherwise. You are cautioned not to put undue reliance on these forward-looking statements. _________________________ 1 Warikoo N, Schwartz T, Citrome L. Tardive dyskinesia. In: Schwartz TL, Megna J, Topel ME, eds. Antipsychotic Drugs. Hauppauge, NY: Nova Science Publishers. 2013:235-258. 2 Waln O, Jankovic J. An Update on Tardive Dyskinesia: From Phenomenology to Treatment. Tremor Other Hyperkinet Mov. 2013;3:1-11. 3 Tardive dyskinesia. National Alliance on Mental Illness website. . Accessed May 4, 2023. View source version on businesswire.com: Contacts PR Contacts Kelley Dougherty +1 (973) 832-2810 Eden Klein +972 (3) 906 2645 IR Contacts Yael Ashman +972 (3) 914 8262 Sanjeev Sharma +1 (973) 658 2700 Ran Meir +1 (267) 468-4475 Source: Teva Pharmaceutical Industries Limited View this news release online at:

Clinical ResultPhase 3Drug Approval

31 May 2024

·www.fiercebiotech.com

Chutes & Ladders—Roche veteran James Sabry hangs up his hat

None Welcome to this week's Chutes & Ladders, our roundup of significant leadership hirings, firings and retirings across the industry. Please send the good word—or the bad—from your shop to Gabrielle Masson and it will be featured here at the end of each week. Roche bids adieu to pharma BD vet Sabry Roche It’s the end of an era at Roche as veteran dealmaker James Sabry, Ph.D., hangs up his hat following 14 years at the company. Sabry, whose retirement was announced earlier this week, will be exiting his role as head of Roche Pharma Partnering, which he assumed in 2018. Sabry started his career at the Swiss pharma giant back in 2010 when he joined Roche’s Genentech as head of partnering. Roche’s current head of group business development, Boris Zaïtra, will take up the baton in Sabry’s absence. July 1, Zaïtra will assume the role of head of corporate business development, a new position that weds the functions of both Roche’s pharma partnering and group business development operations. In his new post, Zaïtra will join Roche’s corporate executive committee. Zaïtra has been with Roche in his current role since 2012. With regards to Sabry’s departure, Roche’s CEO Thomas Schinecker noted in a statement that the executive “has been instrumental in forging important deals for our Pharma R&D pipeline that have led to numerous launches of new medicines,” adding that external innovation would continue to be a critical part of Roche’s business strategy. Release Vir fills vacant CMO spot Vir Biotechnology Just a few months after Vir Biotechnology installed Bayer’s Marianne De Backer, Ph.D., as CEO, the company has also named a new chief medical officer. Mark Eisner, M.D., is slated to step on as Vir’s executive vice president and CMO starting June 3. He fills the spot of Phil Pang, M.D., Ph.D., who left the immunology company at the end of March to spend more time with his family. Eisner joins from cell therapy biotech Sonoma Biotherapeutics, where he also served as CMO. The leader has also clocked in time at FibroGen and Roche’s Genentech, where he served as senior vice president and global head of product development immunology, infectious disease and ophthalmology. Eisner’s expertise with late-stage clinical trials and immunology and infectious disease will be key to Vir’s next stage of growth, De Backer said in a May 29 announcement. Release Neurocrine maps out CEO succession plan Neurocrine Biosciences *Cue the “Succession” theme song.* Neurocrine Biosciences has selected its next leader alongside the announcement that current CEO Kevin Gorman, Ph.D., will retire after nearly 32 years at the company that he helped start in the early '90s. That tenure included shifts as Neurocrine’s chief business officer, chief operating officer and, since January 2008, president and chief executive. Gorman will step down Oct. 11, when he’ll be succeeded by Kyle Gano, Ph.D., who’s also put in multiple decades at Neurocrine. Since joining in 2001, Gano has held various leadership roles across the company, culminating in his appointment as chief business development officer in 2011 and the addition of the chief strategy officer title in 2020. Gano will take the reins amid a busy time for Neurocrine. As he noted in a statement, “This is an important year for our organization, as we look to help even more patients with tardive dyskinesia and Huntington's disease through INGREZZA, while potentially bringing crinecerfont to CAH patients in 2025–all while advancing our pipeline.” When the CEO baton is passed this fall, Gorman will remain a member of Neurocrine’s board of directors, and Gano will take a board seat of his own. Fierce Pharma > South San Francisco-based synthetic lethality specialist Ideaya Biosciences is getting ready to welcome a new executive into the fold later this summer. The company has appointed Daniel Simon to serve as its chief business officer starting in August. Simon comes over from Revolution Medicines, where he served in the same role from 2022 to 2024. Prior to that, he was SVP of biopharma business development at Guardant Health. Release > Monte Rosa Therapeutics has rounded out May with a suite of leadership promotions. Sharon Townson, Ph.D., who joined the molecular glue degrader developer as chief technology officer, is being elevated to the role of chief scientific officer. Meanwhile, Monte Rosa’s current general counsel Phil Nickson, Ph.D., is being promoted to chief business and legal officer. And Jennifer Champoux, who joined the company as vice president of operations, has become chief operating officer. Release > As Nurix Therapeutics plows ahead with development of its small-molecule BTK degrader NX-5948, the San Francisco-based biotech is bulking up in the C-suite. Nurix has enlisted Paula O’Connor, M.D., to serve as its chief medical officer, while Pasit Phiasivongsa, Ph.D., has signed on as chief technical officer. O’Connor joined Nurix in 2022 and most recently served as VP and head of clinical development. Phiasivongsa also joined Nurix in 2022 and most recently held the role as EVP of technical operations. Release > James Ahlers has been removed from his executive officer role at Intensity Therapeutics, a move made “solely in recognition of the reduced scope of [his] responsibilities” rather than any disagreement with the company, according to a regulatory filing. Ahlers originally joined Intensity as CFO in early 2022 before being named executive VP of corporate finance in June 2023. He’ll stay on as a senior consultant to the company. Release > Cardiovascular gene editing company Verve Therapeutics's Chief Scientific Officer Andrew Bellinger, M.D., Ph.D., is stepping down. Starting June 21, Troy Lister, Ph.D., Verve’s senior vice president of research and early development, will take on the CSO role. Release > Sapreme Technologies has a new CEO: The Dutch biotech has appointed Marco Timmers, Ph.D., former CEO and CSO of Byondis, to replace Guy Hermans, Ph.D., as chief executive. Meanwhile, Sapreme also named the first four members of its newly established scientific advisory board and selected Jeanne Bolger, M.D., previously VP of venture investing for Johnson & Johnson Innovation, to serve as chair of the board of directors. Release > Patrice Matchaba, M.D., is the new CEO of the Bill & Melinda Gates Medical Research Institute, effective June 10. Matchaba previously spent more than two decades in various leadership roles at Novartis, culminating in a term as president of the pharma’s US Foundation. He’ll take over from Emilio Emini, Ph.D., who recently announced his retirement from the institute after nearly three years as CEO following stints at Merck, Pfizer and the Gates Foundation. Release > Iterum Therapeutics' Chief Medical Officer Sailaja Puttagunta, M.D., is transitioning into a consulting role. Puttagunta will hold the position through the FDA's review of Iterum's resubmitted new drug application for oral sulopenem to treat uncomplicated urinary tract infections in women. A decision is expected by Oct. 25. Release > On May 28, Compass Therapeutics’ CEO Vered Bisker-Leib, Ph.D., resigned from his role and instead stepped into a consultant position. In his place, the board tapped Thomas Schuetz, M.D., Ph.D., R&D president and vice chair of the board of directors, as CEO and president plus principal executive officer, principal financial and principal accounting officer of Compass. Release > mRNA-focused Omega Therapeutics has tapped Kaan Certel, Ph.D., to lead the biotech’s business development. Most recently, Certel was BioCity Biopharma’s chief business officer, and, before that, served as Sanofi’s global head of oncology external innovation. Release > Precision medicine company Entact Bio has elected Michael Gutch, Ph.D., to serve as chief operating officer. Gutch joins Entact from Noema Pharma, and has past experience at Entasis Therapeutics and AstraZeneca, among others. Release > Alkeus Pharmaceuticals has appointed Eric Trachtenberg as chief legal officer. The leader joins from Kala Bio, where he served as chief legal officer, chief compliance officer and corporate secretary. Release

Executive Change

31 May 2024

·www.biopharmadive.com

FDA delays decision on Dupixent in COPD; Summit makes a bold claim

BioPharma Dive is testing out a new format rounding up smaller updates from around the industry. Have thoughts on what could make this type of story better? Drop us a line!Today, a brief rundown of news from Regeneron, Summit Therapeutics and Verve Therapeutics, as well as updates from Bristol Myers Squibb and Neurocrine Biosciences that you may have missed from this week.Regeneron and partner Sanofi announced Friday the Food and Drug Administration has delayed by three months an approval decision for their drug Dupixent in chronic obstructive pulmonary disease, or COPD. The companies had previously asked the agency to expand Dupixents use to include maintenance treatment for certain adults with uncontrolled COPD. But the FDA requested extra trial data, and therefore extended its review to Sept. 27. The announcement comes the same day as regulators in the EU recommended an approval in COPD. Delilah AlvaradoAndrew Bellinger, the chief scientific officer of Verve Therapeutics, is stepping down from his role effective June 21, according to a Friday announcement. Bellinger has served as Verve's CSO since 2019 and will move to an advisory role. Troy Lister, currently senior vice president of research and early development, will take Bellinger's place. In a statement on X, Bellinger said it has been an honorto serve as the company's first CSO, adding that he felt it was the right time for him to move on to other opportunities. Delilah AlvaradoSummit Therapeutics, a biotechnology company based in Miami, Florida, on Thursday said that a bispecific antibody its developing beat Merck & Co.s Keytruda in a head-to-head study of people with non-small cell lung cancer. According to Summit, its drug, ivonescimab, significantly improved progression-free survival versus Keytruda across clinical subgroups. However, the company did not disclose any data and the trial was conducted solely in China. Regulators in the U.S. have previously sought evidence that single-country trials are reproducible in different demographic groups. Ned PagliaruloBristol Myers Squibbs cell therapy Breyanzi won Food and Drug Administration approval Thursday for another type of blood cancer, mantle cell lymphoma, following past approvals in large B cell lymphoma, follicular lymphoma and chronic lymphocytic leukemia. In mantle cell, it can now be used when patients progress following two systemic treatments, including one targeted therapy like AstraZenecas Calquence. Breyanzis approval was based on the TRANSCEND NHL 001 study, in which 85% of people given the therapy saw a reduction in the number of diseased white blood cells, and 68% who saw a complete elimination of detectable diseased cells. Breyanzi recorded sales of $364 million in 2023. Jonathan GardnerKevin Gorman, the founder and longtime leader of Neurocrine Biosciences, is retiring later this year after 16 years as the companys CEO. Hell be replaced by Kyle Gano, another Neurocrine veteran who has served as chief business development and strategy officer since 2020. Neurocrine has grown significantly with Gorman at the helm, developing and launching the rare disease drug Ingrezza. Ned Pagliarulo '

Executive ChangeCell TherapyAccelerated ApprovalClinical Study

100 Deals associated with Valbenazine Tosylate

External Link

KEGG	Wiki	ATC	Drug Bank
-	Valbenazine Tosylate	N07XX13	DB11915

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Huntington Disease	US	Neurocrine Biosciences, Inc.	18 Aug 2023
Tardive Dyskinesia	US	Neurocrine Biosciences, Inc.	11 Apr 2017

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Cerebral Palsy	Phase 3	US	Neurocrine Biosciences, Inc.	30 Jan 2022
Schizophrenia	Phase 3	US	Neurocrine Biosciences, Inc.	29 Nov 2021
Schizophrenia	Phase 3	BG	Neurocrine Biosciences, Inc.	29 Nov 2021
Schizophrenia	Phase 3	RS	Neurocrine Biosciences, Inc.	29 Nov 2021
Trichotillomania	Phase 2	US	Neurocrine Biosciences, Inc.	01 Oct 2023
Tourette Syndrome	Phase 2	US	Neurocrine Biosciences, Inc.	01 Nov 2015
Schizoaffective disorder	Phase 2	CA	Neurocrine Biosciences, Inc.	01 Jan 2011
Thanatophoric Dysplasia	Phase 1	-	Neurocrine Biosciences, Inc.	01 Apr 2024

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


FDA_CDER Manual	Not Applicable	Tardive Dyskinesia	445	INGREZZA 40 mg	lavrhalgjp(bzgxvihuai) = wvhtylvnem nrpenfalkq (qvjoouyqfi, 0.4)	Positive	30 Apr 2024
				INGREZZA 80 mg	lavrhalgjp(bzgxvihuai) = ecyqmbugjd nrpenfalkq (qvjoouyqfi, 0.4)
NCT04102579 (FDA_CDER) Manual	Phase 3	Huntington Disease	128	INGREZZA	slcbmhfmyg(wzbrjcsqci) = brdkjqpxcx onlzwkqopk (opyrmrinfy, 0.4) View more	Positive	30 Apr 2024
NCT04400331 (KINECT-HD2, Biospace) Manual	Phase 3	Huntington Disease	-	INGREZZA	amerdilnod(sabnrgikgd) = oazagwcngu iilwjqotyy (mfegjmjdjh ) View more	Positive	02 Nov 2023
NCT04102579 (KINECT-HD, CTgov)	Phase 3	Huntington Disease	128	Valbenazine (Valbenazine)	gcsqwnjhyl(jjreiliery) = bstfapgssf pwbsoavdlb (etyyxfahkj, kfohqvyiry - aezjbbercr) View more	-	11 Oct 2023
				Placebo (Placebo)	gcsqwnjhyl(jjreiliery) = hubkzfzaop pwbsoavdlb (etyyxfahkj, tjwnvdjmjq - ernklvegfs) View more
NCT02405091 (KINECT-4, MDS2023) Manual	Phase 3	Tardive Dyskinesia	163	Valbenazine Tosylate	qhdbaucopi(hxrgliztdf) = zdkrwernkf gezimgqfuk (kzcvxnkhcu ) View more	Positive	31 Aug 2023
MDS2023	Not Applicable	Crush Syndrome	-	Valbenazine capsule contents	tslqlcefqt(hdfegsmsyf) = hapbhzcniz tgsmhpxqvr (bpinzdrgln ) View more	-	27 Aug 2023
MDS2023	Not Applicable	Huntington Disease	-	Valbenazine	ljiefoomgx(trgitsqkil): relative treatment effects = -1.87 (95% CI, -3.23 to -0.52)	-	27 Aug 2023
				Deutetrabenazine
FDA Manual	Not Applicable	Tardive Dyskinesia	234	INGREZZA	anzkhjqhqb(vjgbmcqapg) = tthtuvzetg yvsdddkbtj (kxsgxokgqt, 0.4)	Positive	18 Aug 2023
				INGREZZA (80 mg)	anzkhjqhqb(vjgbmcqapg) = zvcqdkmebj yvsdddkbtj (kxsgxokgqt, 0.4)
NCT04102579 (FDA) Manual	Phase 3	Huntington Disease	125	INGREZZA	kftlciiikb(phlnrrifzw) = ktovhpesfw jxkeqmmokl (ikosdrdvwu, 0.4) View more	Positive	18 Aug 2023
				Placebo	kftlciiikb(phlnrrifzw) = tatezgmkhw jxkeqmmokl (ikosdrdvwu, 0.4) View more
NCT03176771 (CTgov)	Phase 2/3	Tardive Dyskinesia	256	Placebo (Placebo (Double-Blind Placebo-Controlled Period))	xygxojhhin(elbtjtlsfo) = gepxmapoew utylyvttvz (xpbjenkpqs, hmdfcjzvpi - xkmahwgaub) View more	-	14 Aug 2023
				MT-5199 (MT-5199 40 mg (Double-Blind Placebo-Controlled Period))	xygxojhhin(elbtjtlsfo) = oqehcigemf utylyvttvz (xpbjenkpqs, kctgqugduk - hbewiryvfc) View more

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