A Phase 3 Randomized, Active-Controlled, Double-Masked Study to Evaluate the Safety and Efficacy of TRS01 Eye Drops in the Treatment of Subjects With Active Non-infectious Anterior Uveitis Including Subjects With Uveitic Glaucoma

The primary objective of this study is to evaluate the efficacy and safety of TRS01 eye drops compared to active comparator in subjects with active non-infectious anterior uveitis with or without uveitic glaucoma

Start Date20 Sep 2021

Sponsor / Collaborator

Tarsier Pharma Ltd.Startup

NCT04222712 / CompletedPhase 1/2

A Randomized, Double-Masked, Dose-Ranging Study to Evaluate the Safety and Tolerability of TRS01 Eye Drops in Participants With Active Non-infectious Anterior Uveitis.

The objective of this study is to evaluate the safety of TRS01 eye drops in participants with active non-infectious anterior uveitis
.

Start Date01 Feb 2020

Sponsor / Collaborator

Tarsier Pharma Ltd.Startup

NCT04222725 / CompletedPhase 1/2

A Multicenter, Double-Masked, Randomized, Vehicle-controlled, Dose-ranging Study to Evaluate the Safety of TRS01 Eye Drops in Participants With Post-surgical Inflammation

The objective of this study is to evaluate the safety and preliminary efficacy of TRS01 eye drops as compared to placebo on participants with ocular inflammation after cataract surgery.

Start Date01 Feb 2020

Sponsor / Collaborator

Tarsier Pharma Ltd.Startup

100 Clinical Results associated with Dazdotuftide

100 Translational Medicine associated with Dazdotuftide

100 Patents (Medical) associated with Dazdotuftide

Literatures (Medical) associated with Dazdotuftide

01 Jan 2024·The Journal of surgical research

Recovery Services for Interpersonal Violence Victims on Healthcare Use at a Trauma Center

Article

Author: Zhu, Kevin Y ; Sun, Kristie J ; Breslin, Mary A ; Moon, Tyler J ; Vallier, Heather A ; Ho, Vanessa P

INTRODUCTION:

Treatment of interpersonal violence (IPV) patients is often complicated by social and mental health comorbidities. New American College of Surgeons (ACS) requirements include provision of psychosocial support services for recovery after injury. We aim to describe utilization and patient outcomes after provision of Trauma Recovery Services (TRS) at our institution for the IPV population. These services include assistance with food, housing, criminal justice, and advocacy.

METHODS:

IPV patients were identified between September 6, 2018 and December 20, 2020. Demographic information was collected. TRS utilization and specific services rendered were identified. Primary outcome measures included initial length of stay (LOS), number of subsequent emergency department (ED) visits, and outpatient visits within 1 y after the initial injury. Statistical analyses included t-tests, Chi-squared tests, and multivariate regression analyses.

RESULTS:

A total of 502 patients were included in the final cohort, and 394 patients (78.5%) accepted the utilization of TRS services after initial interaction. Patients were on average 33.4 y old, and 59.4% were females. Patients who were older (P < 0.001) and homeless (P = 0.004) were more likely to use TRS, while victims of sexual assault (P < 0.001) and single patients (P = 0.041) were less likely. Patients who utilized TRS had longer initial LOS (P < 0.001), more ED visits (P < 0.001), and more outpatient visits (P = 0.01) related to the initial complaint, independent of potential confounders on multivariate linear regression. Food and housing service utilization associated with LOS (P = 0.01), ED visits (P < 0.001), and outpatient visits (P < 0.001). Additionally, transportation services were associated with longer LOS (P = 0.01) while patient advocacy services were associated with more ED visits (P = 0.03).

CONCLUSIONS:

TRS was extensively utilized by IPV patients, and associated with more follow-up appointments, ED visits, and longer LOS. Emphasis on injury mechanisms, baseline demographics, and social features may further characterize patients in need who tend toward utilization.

01 Jan 2024·Alzheimer's & dementia : the journal of the Alzheimer's Association

Transcriptional risk scores in Alzheimer's disease: From pathology to cognition

Article

Author: Park, Young Ho ; Nho, Kwangsik ; Saykin, Andrew J ; Pyun, Jung-Min ; Bice, Paula J ; Kim, SangYun ; Kim, Jun Pyo ; Bennett, David A ; Wang, Jiebiao

Abstract:

INTRODUCTION:

Our previously developed blood‐based transcriptional risk scores (TRS) showed associations with diagnosis and neuroimaging biomarkers for Alzheimer's disease (AD). Here, we developed brain‐based TRS.

METHODS:

We integrated AD genome‐wide association study summary and expression quantitative trait locus data to prioritize target genes using Mendelian randomization. We calculated TRS using brain transcriptome data of two independent cohorts (N = 878) and performed association analysis of TRS with diagnosis, amyloidopathy, tauopathy, and cognition. We compared AD classification performance of TRS with polygenic risk scores (PRS).

RESULTS:

Higher TRS values were significantly associated with AD, amyloidopathy, tauopathy, worse cognition, and faster cognitive decline, which were replicated in an independent cohort. The AD classification performance of PRS was increased with the inclusion of TRS up to 16% with the area under the curve value of 0.850.

DISCUSSION:

Our results suggest brain‐based TRS improves the AD classification of PRS and may be a potential AD biomarker.

Highlights:

Transcriptional risk score (TRS) is developed using brain RNA‐Seq data.Higher TRS values are shown in Alzheimer's disease (AD).TRS improves the AD classification power of PRS up to 16%.TRS is associated with AD pathology presence.TRS is associated with worse cognitive performance and faster cognitive decline.

01 Dec 2023·Injury

Trauma recidivism is reduced with engagement in psychosocial programming following orthopaedic trauma

Article

Author: Moore, Timothy A ; Simpson, Megen ; Breslin, Mary A ; Hendrickson, Sarah B ; Vallier, Heather A ; Heimke, Isabella M ; Simske, Natasha M ; Furdock, Ryan ; Swetz, Anna

INTRODUCTION:

Recidivism is common following injury. Interventions to enhance patient engagement may reduce trauma recidivism. Education, counseling, peer mentorship, and other resources are known as Trauma Recovery Services (TRS). The authors hypothesized that TRS use would reduce trauma recidivism.

METHODS:

Over five years at a level 1 trauma center, 954 adults treated operatively for pelvic, spine, and femoral fractures were reviewed. Recidivism was defined as return to trauma center for new injury within 30-months. All patients were offered TRS. Multivariate logistic regression statistical analysis was used to identify predictors of recidivism.

RESULTS:

Three hundred and ninety-seven of all patients (42 %) utilized TRS, including educational materials (n = 293), peer visits (n = 360), coaching (n = 284), posttraumatic stress disorder (PTSD) screening (n = 74), and other services. Within the entire sample, 136 patients (14 %) returned to the emergency department for an unrelated trauma event after mean 21 months. 13 % of TRS users became recidivists. Overall, 49 % of recidivists had history of pre-existing mental illness. High rates of TRS engagement between recidivists and non-recidivists were seen (75 %); however, non-recidivists were more likely to use multiple types of recovery services (49 % vs 34 %, p = 0.002), and were more likely to engage with trauma peer mentors (former trauma survivors) more than once (91 % vs 81 %, p = 0.03). After multivariable analysis, patients using multiple different recovery services had a lower risk of recidivism (p = 0.04, OR 0.42, 95 % CI [0.19-0.96]).

CONCLUSIONS:

Multifaceted engagement with recovery programming is associated with less recidivism following trauma. Future study of resultant reductions in healthcare costs are warranted.

LEVEL OF EVIDENCE:

Level II; Prognostic.

News (Medical) associated with Dazdotuftide

28 May 2024

·www.prnewswire.com

Tarsier Pharma Announces the Appointment of Emilee Fulcher as Vice President of Clinical Affairs

TEL-AVIV, Israel, May 28, 2024 /PRNewswire/ -- Tarsier Pharma, Ltd, a late-stage ophthalmic biopharmaceutical company focused on developing and commercializing first-in-class new therapies for the treatment of blinding ocular diseases proudly announces the appointment of Emilee Fulcher as Vice President of Clinical Affairs. Continue Reading Emilee Fulcher, VP Clinical Affairs, Tarsier Pharma Ltd. In her new role, Emilee Fulcher will spearhead the execution of the TRS01 and TRS02 clinical programs towards the advancement of Tarsier Pharma's pipeline for Dazdotuftide (TRS). Dazdotuftide is a novel, multi-target drug with a unique mechanism of action in development for the treatment of ocular blinding diseases as an eye drop formulation (TRS01) and slow-release biodegradable intravitreal injection (TRS02). "We are thrilled to welcome Emilee to the Tarsier team as our Vice President of Clinical Affairs," said Daphne Haim-Langford CEO of Tarsier. "Emilee's exceptional leadership, proven track record, and deep understanding of ophthalmic research make her the ideal candidate to lead our clinical development efforts. She is knowledgeable, professional, deeply compassionate, and fully aligned with the company's vision to save sight, which makes her an invaluable asset to the team". Emilee has 20 years of experience in the pharmaceutical industry with a specialized background in executing ophthalmology clinical trials. Prior to joining Tarsier, Emilee was one of the first employees of Lexitas, an ophthalmic-focused CRO. During her 11-year tenure at Lexitas she successfully led trials spanning across multiple ophthalmic indications and phases, including all three trials in the TRS01 clinical program completed to-date. Prior to that, she held positions in preclinical drug development and in clinical operations at UCB Biosciences and Inspire Pharmaceuticals. Emilee stated "I am deeply honored to officially join the talented team at Tarsier and am excited to leverage my expertise as we strive to bring our innovative treatment to patients. I am passionate about our mission at Tarsier and eager to progress our clinical programs that have the potential to revolutionize the treatment paradigm for patients with debilitating and blinding conditions including uveitis and specifically uveitic glaucoma. As we embark on initiating the Tarsier-04 Phase 3 trial, we are poised to build on the momentum of our recently completed TRS4Vision Phase 3 trial that demonstrated the potential of TRS01 to serve as an effective and safe treatment in uveitis that meets the urgent need for a drug that resolves inflammation and with a superior IOP safety profile." Tarsier Pharma congratulates Emilee Fulcher on her appointment and looks forward to her leadership in driving the company's clinical development efforts forward. Photo: Contact: Investor Relations Tarsier Pharma [email protected] SOURCE Tarsier Pharma

Executive ChangePhase 3

06 Mar 2024

·www.businesswire.com

Global Anterior Uveitis (Iritis) Drug Pipeline Research Report 2024 - ResearchAndMarkets.com

DUBLIN--( BUSINESS WIRE )--The "Anterior Uveitis - Pipeline Insight, 2024" clinical trials has been added to ResearchAndMarkets.com's offering. This report provides comprehensive insights about 3+ companies and 3+ pipeline drugs in Anterior Uveitis pipeline landscape. It covers the pipeline drug profiles, including clinical and nonclinical stage products. It also covers the therapeutics assessment by product type, stage, route of administration, and molecule type. It further highlights the inactive pipeline products in this space. The report outlays comprehensive insights of present scenario and growth prospects across the indication. A detailed picture of the Anterior Uveitis pipeline landscape is provided which includes the disease overview and Anterior Uveitis treatment guidelines. The assessment part of the report embraces, in depth Anterior Uveitis commercial assessment and clinical assessment of the pipeline products under development. In the report, detailed description of the drug is given which includes mechanism of action of the drug, clinical studies, NDA approvals (if any), and product development activities comprising the technology, Anterior Uveitis collaborations, licensing, mergers and acquisition, funding, designations and other product related details. Report Highlights The companies and academics are working to assess challenges and seek opportunities that could influence Anterior Uveitis R&D. The therapies under development are focused on novel approaches to treat/improve Anterior Uveitis Anterior Uveitis Emerging Drugs Chapters This segment of the Anterior Uveitis report encloses its detailed analysis of various drugs in different stages of clinical development, including phase II, I, preclinical and Discovery. It also helps to understand clinical trial details, expressive pharmacological action, agreements and collaborations, and the latest news and press releases. Anterior Uveitis Emerging Drugs TRS01: Tarsier Pharma Dazdotuftide (formerly known as TRS01) is a first-in-class drug with a new and unique mechanism of action, for the treatment of ocular blinding diseases of back- and front- of the eye. Dazdotuftide is a bio-inspired novel proprietary technology platform, based on a New Chemical Entity (NCE) with a disruptive mechanism of action. Dazdotuftide was found to modulate macrophages from inflammatory macrophages (M1) to IL-10 secreting ant-inflammatory macrophages (M2). Due to dazdotuftide's unique mechanism of action of immunomodulation, it has the potential to treat these debilitating diseases with a sustained effect and minimal risk of IOP elevation. Currently, the drug is Phase III stage of its clinical trial for the treatment of anterior uveitis. Anterior Uveitis Pipeline Development Activities The report provides insights into different therapeutic candidates in phase II, I, preclinical and discovery stage. It also analyses Anterior Uveitis therapeutic drugs key players involved in developing key drugs. Pipeline Development Activities The report covers the detailed information of collaborations, acquisition and merger, licensing along with a thorough therapeutic assessment of emerging Anterior Uveitis drugs. Anterior Uveitis Therapeutic Assessment Major Players in Anterior Uveitis There are approx. 3+ key companies which are developing the therapies for Anterior Uveitis. The companies which have their Anterior Uveitis drug candidates in the most advanced stage, i.e. Phase III include, Tarsier Pharma. Phases: The report covers around 3+ products under different phases of clinical development like Late stage products (Phase III) Mid-stage products (Phase II) Early-stage product (Phase I) along with the details of Pre-clinical and Discovery stage candidates Discontinued & Inactive candidates Route of Administration Anterior Uveitis pipeline report provides the therapeutic assessment of the pipeline drugs by the Route of Administration. Products have been categorized under various ROAs such as Oral Intravenous Subcutaneous Parenteral Topical Molecule Type Products have been categorized under various Molecule types such as Recombinant fusion proteins Small molecule Monoclonal antibody Peptide Polymer Gene therapy Product Type Anterior Uveitis Report Insights Anterior Uveitis Pipeline Analysis Therapeutic Assessment Unmet Needs Impact of Drugs Anterior Uveitis Report Assessment Pipeline Product Profiles Therapeutic Assessment Pipeline Assessment Inactive drugs assessment Unmet Needs Key Players Tarsier Pharma Oculis Pharma Novaliq Key Products TRS01 OCS 2 Tacrolimus For more information about this clinical trials report visit https://www.researchandmarkets.com/r/tkzvsx About ResearchAndMarkets.com ResearchAndMarkets.com is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends.

Phase 2Phase 3Gene Therapy

16 Jan 2024

·www.prnewswire.com

Tarsier Pharma Receives FDA Agreement Under Special Protocol Assessment (SPA) for Tarsier-04 Phase 3 Trial of TRS01 Ophthalmic Solution for the Treatment of Non-infectious Uveitis including Uveitic Glaucoma

TEL AVIV, Israel , Jan. 16, 2024 /PRNewswire/ -- Tarsier Pharma, Ltd., a clinical-stage ophthalmic biopharmaceutical company focused on developing and commercializing first-in-class new therapies for the treatment of blinding ocular diseases, today announced it has received agreement from the U.S. Food and Drug Administration (FDA) under a Special Protocol Assessment (SPA) for the clinical trial protocol and planned statistical analysis of the Tarsier-04 Phase 3 trial to evaluate TRS01 eye drops for the treatment of non-infectious uveitis including uveitic glaucoma. Continue Reading Daphne Haim-Langford, Ph.D, Founder & CEO Tarsier Pharma Ltd. A SPA agreement indicates concurrence by FDA with the adequacy and acceptability of specific critical elements of overall protocol design for a study intended to support a future marketing application. "The SPA agreement with the FDA provides a clear regulatory path for TRS01. The approved protocol of the upcoming Tarsier-04 trial was designed to replicate the TRS4Vision trial, with revised endpoints that are aimed to emphasize the benefit/risk profile of TRS01, based on lessons learned from the TRS4Vision trial", said Daphne Haim-Langford, Ph.D, Founder and CEO of Tarsier. "The primary endpoint in this FDA approved protocol is one that achieved an alpha <0.01 in the TRS4Vision trial, thus we have strong reasons to believe that the endpoints of Tarsier-04 will be met, and this SPA agreement with the FDA is bringing TRS01 much closer to patients in need". "Patients dealing with non-infectious uveitis endure a lifelong struggle to safeguard their vision. Despite current treatments, a majority of patients eventually suffer vision loss, significantly impacting their quality of life. The fear of blindness, affecting 22% of patients, adds another layer of devastation," stated Prof. Palestine. Director, Center for Ocular Inflammation at the University of Colorado Department of Ophthalmology. "Presently, there are no FDA-approved, steroid-free topical medications for this condition. An eye drop product that effectively resolves inflammation without raising intraocular pressure is a long standing, so far unachievable, goal in our field. After over 40 years of treating non-infectious uveitis and actively participating in efforts to develop new therapies, drawing confidence from the positive outcomes of the TRS4Vision trial I'm optimistic that we're closer than ever to controlling inflammation without increasing the risk of glaucoma and that TRS01 can serve as a new first-line-treatment for non-infectious uveitis replacing topical steroids." Tarsier received written agreement from the FDA that the clinical trial protocol and planned statistical analysis of the Tarsier-04 Phase 3 trial of TRS01 address objectives supporting regulatory submission and a potential future marketing application in this indication. Tarsier-04 will be a multi-center, randomized, double-masked, active-controlled Phase 3 trial designed to evaluate the efficacy and safety of TRS01 eye drops in non-infectious uveitis including patients with uveitic glaucoma, and is planned to enroll up to 300 patients in the U.S. "We are grateful for the FDA's professional support and guidance", said Ms. Zohar Milman, M.Sc, COO of Tarsier. "With this swift agreement, we are now focused on gearing up preparations toward the trial start-up activities.". About Tarsier Pharma Tarsier Pharma is a clinical stage biopharmaceutical company, focused on the discovery, development, and commercialization of first-in-class pharmaceutical therapies to treat immune-mediated blinding diseases in the front and back of the eye. About TRS01 Dazdotuftide (formerly known as TRS) is a first-in-class drug with a new and unique mechanism of action, for the treatment of ocular blinding diseases of back- and front- of the eye. Dazdotuftide is a bio-inspired novel proprietary technology platform, based on a New Chemical Entity (NCE) with a disruptive mechanism of action. Dazdotuftide was found to modulate macrophages from inflammatory macrophages (M1) to IL-10 secreting ant-inflammatory macrophages (M2). Tarsier is developing dazdotuftide as an eye drop formulation (TRS01) for front-of-the-eye indications and as a slow-release biodegradable intravitreal injection (TRS02) targeting back-of-the-eye blinding indications with an underlying inflammatory pathology, such as Diabetic Macular Edema, Non-Proliferative Diabetic Retinopathy, and others. Due to dazdotuftide's unique mechanism of action of immunomodulation, we believe it has the potential to treat these debilitating diseases with a sustained effect and minimal risk of IOP elevation. About Uveitic Glaucoma Non-infectious uveitis is a chronic autoimmune disease of the eye and the third leading cause of blindness. Despite available treatment options, 67% of patients suffering from non-infectious uveitis reaching visual impairment and 22% are meeting a legal blindness criterion. The current treatment for active non-infectious anterior uveitis is topical steroids. Since their introduction to the eye 70 years ago, topical steroids have been used as first line treatment due to their potency in resolving inflammation. While potent in resolving inflammation, topical steroids carry a high risk of intraocular pressure (IOP) elevation mediated by steroids' receptors, and often if treatment is ceased without long tapering period, a recurrent rebound inflammation occurs. In some patients, IOP elevation leads to glaucoma (i.e., uveitic glaucoma). Uveitic glaucoma is a challenging disease to treat, with a unique pathophysiology, disease course, prognosis, and a significantly more difficult clinical course to manage than anterior uveitis without glaucoma. The overall prevalence of glaucoma in eyes with uveitis (i.e., uveitic glaucoma) varies from 10 to 20 percent but is much more common in chronic uveitis and can be as high as 46 percent. For more information, visit . Contact: Daphne Haim-Langford, Ph.D Founder & CEO [email protected] Photo - SOURCE Tarsier Pharma

Phase 3

100 Deals associated with Dazdotuftide

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Indication	Highest Phase	Country/Location	Organization	Date
Uveitic Glaucoma	Phase 3	IL	Tarsier Pharma Ltd.Startup	30 Jan 2022
Uveitis, Anterior	Phase 3	IL	Tarsier Pharma Ltd.Startup	30 Jan 2022
Non-infectious anterior uveitis	Phase 2	US	Tarsier Pharma Ltd.Startup	01 Feb 2020
Ocular inflammation	Phase 2	US	Tarsier Pharma Ltd.Startup	01 Feb 2020
Diabetic macular oedema	Preclinical	IL	Tarsier Pharma Ltd.Startup	30 Jan 2022
dry age-related macular degeneration	Preclinical	IL	Tarsier Pharma Ltd.Startup	30 Jan 2022
Nonproliferative diabetic retinopathy	Preclinical	IL	Tarsier Pharma Ltd.Startup	30 Jan 2022

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04222712 (CTgov)	Phase 1/2	Non-infectious anterior uveitis	16	TRS01 eye drops (TRS01 Low Dose)	benqxcsxsp(rhdnhxdcnm) = vfbzlgblde jvyuyppfoq (itskokwcxp, bmbntkyzzr - xjfszxbaob) View more	-	05 Oct 2023
				TRS01 eye drops (TRS01 High Dose)	benqxcsxsp(rhdnhxdcnm) = kfhpwqyedx jvyuyppfoq (itskokwcxp, mliyxwnxnf - mrraljtcjf) View more
NCT04222725 (CTgov)	Phase 1/2	Ocular inflammation	37	TRS01 eye drops (TRS01 Low Dose)	ddxxktpagl(kptqklqlfb) = nfhcxtypth kchmspppku (psghcykknv, ttpquarsby - kymuerjcui) View more	-	14 Oct 2021
				TRS01 eye drops (TRS01 Medium Dose)	ddxxktpagl(kptqklqlfb) = usnxxjrwbn kchmspppku (psghcykknv, cfxwfvbcsx - labgpezems) View more

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