repibresib (VYN201) / Vyne Therap, Tay Therap - LARVOL DELTA

VYNE Therapeutics Announces Topline Results from Phase 2b Trial with Repibresib Gel in Nonsegmental Vitiligo (GlobeNewswire) - P2b | N=200 | NCT06493578 | Sponsor: Vyne Therapeutics Inc. | "The trial, which evaluated 177 subjects, did not meet its primary endpoint of the proportion of subjects achieving an improvement in Facial Vitiligo Area Scoring Index of at least 50% from baseline (F-VASI50) at week 24 compared to vehicle. The trial also missed a key secondary endpoint of F-VASI75. However, the trial showed a nominally statistically significant treatment effect for the highest dose cohort in a key secondary endpoint, percent change-from-baseline (CFB) in F-VASI score at week 24 compared to vehicle (Repibresib 3%: -43.6% v. Vehicle: -25.6%), and an exploratory endpoint of percent CFB in T-VASI score at week 24 compared to vehicle (Repibresib 3%: -28.3% v. Vehicle: -16.2%)...Based on these data, the company will discontinue treatment in the ongoing extension phase of the trial and will terminate the trial....'We intend to seek a development and commercialization partner for Repibresib...'"

P2b data • Trial termination • Vitiligo

VYNE Therapeutics Provides Program Update on Oral BET inhibitor VYN202 (GlobeNewswire) - "Following the clinical hold, VYNE made the decision to unblind the clinical data from the subjects who were enrolled in the study (VYN202 treated: n=6 across 0.25 mg, 0.5 mg and 1 mg doses; Placebo treated: n=1), the results of which are described below...The Company believes that the totality of the data from this study, together with promising results from multiple preclinical models, support the continued advancement of VYN202 into serious, immune-mediated diseases with limited effective treatment options. Based on this assessment, the Company will no longer enroll patients in the Phase 1b psoriasis study, extending the Company’s expected cash runway into the fourth quarter of 2026. VYNE expects to provide further updates on its plans for the VYN202 program following the release of top-line results from the ongoing Phase 2b study of its lead candidate repibresib gel (formerly VYN201), a pan-BD BET inhibitor, for the treatment of non-segmental vitiligo."

Enrollment closed • P2b data • Psoriasis • Vitiligo

A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of VYN201 Gel in Subjects With Non-segmental Vitiligo. (clinicaltrials.gov) - P2 | N=200 | Active, not recruiting | Sponsor: Vyne Therapeutics Inc. | Recruiting ➔ Active, not recruiting

Enrollment closed • Dermatology • Immunology • Vitiligo

Phase 2b trial of repibresib gel in nonsegmental vitiligo (GlobeNewswire) - "Repibresib is a distinct and unique compound from VYN202. Top-line results from the 24-week double-blind, vehicle-controlled portion of the Phase 2b trial are expected mid-year."

P2b data • Vitiligo

VYNE Therapeutics Reports 2024 Fourth Quarter and Year-End Financial Results and Provides Business Update (GlobeNewswire) - "Repibresib gel (VYN201), a locally-administered small molecule pan-BD BET inhibitor (Phase 2b, nonsegmental vitiligo): Top-line results from the 24-week double-blind, vehicle-controlled portion of the trial are expected mid-year."

P2b data • Vitiligo

VYNE Therapeutics Completes Enrollment in Phase 2b Trial Evaluating VYN201 for the Treatment of Nonsegmental Vitiligo (GlobeNewswire) - "VYNE Therapeutics Inc...today announced completion of enrollment in the Phase 2b trial evaluating VYN201 gel for the treatment of nonsegmental vitiligo. Top-line data from the 24-week vehicle-controlled treatment period are expected in mid-2025....Additionally, the United States Adopted Names (USAN) Council has adopted 'repibresib' as the non-proprietary name for the new chemical entity in VYN201."

Commercial • Enrollment closed • P2b data • Vitiligo

A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of VYN201 Gel in Subjects With Non-segmental Vitiligo. (clinicaltrials.gov) - P2 | N=160 | Recruiting | Sponsor: Vyne Therapeutics Inc.

New P2 trial • Dermatology • Immunology • Vitiligo

VYNE Therapeutics Announces Dosing of First Subject in Phase 2b Vitiligo Trial of Novel BET Inhibitor VYN201 (GlobeNewswire) - "VYNE Therapeutics...announced that the first subject has been dosed in a Phase 2b trial evaluating VYN201 in subjects with either active or stable nonsegmental vitiligo. VYN201 is a novel pan-bromodomain and extra-terminal domain (BET) inhibitor designed for local administration. Top-line data from the 24-week vehicle-controlled treatment period are expected in mid-2025....The randomized, double-blind, vehicle-controlled trial will evaluate the safety and efficacy of once-daily VYN201 topical gel in three dose cohorts (1%, 2% and 3% concentrations) compared to vehicle for 24 weeks. A total of approximately 160 subjects will be randomized at a 1:1:1:1 ratio."

P2b data • Trial status • Vitiligo

Phase 1b: Translational evaluation of VYN201, a pan-BD BET inhibitor, for the treatment of non-segmental vitiligo (SID 2024) - No abstract available

Late-breaking abstract • P1 data • Dermatology • Immunology • Vitiligo

Preclinical studies: Translational evaluation of VYN201, a pan-BD BET inhibitor, for the treatment of non-segmental vitiligo (SID 2024) - No abstract available

Late-breaking abstract • Preclinical • Dermatology • Immunology • Vitiligo

A Phase 1 Study of the Safety, Pharmacokinetics, and Preliminary Efficacy of a Topical Pan-BD BET Inhibitor (VYN201) in Subjects with Active Non-Segmental Vitiligo. (GVF 2024) - "The results support continued development of VYN201 for the treatment of subjects with NSV. Take Home Message This is the first example of a BET inhibitor demonstrating clinical therapeutic benefit in the treatment of an autoimmune disease with significant unmet need and could provide an alternative mechanism to the current class of JAK inhibitor therapies."

Clinical • P1 data • PK/PD data • Dermatology • Immunology • Inflammation • Pain • Vitiligo • CDH1 • MMP9 • TNFA

VYNE Therapeutics Announces Positive Preclinical Data for Inhaled Formulation of VYN201 in an In Vivo Model of Idiopathic Pulmonary Fibrosis (Yahoo Finance) - "VYNE Therapeutics Inc...announced new preclinical data showing the positive effect of its novel pan-BET inhibitor, VYN201, in a preclinical model of idiopathic pulmonary fibrosis....VYN201 at 0.5 mg/ml and 1 mg/ml demonstrated statistically significant reductions in Ashcroft scores (a measurement of lung fibrosis) and levels of the tissue fibrosis biomarker, hydroxyproline, compared to the placebo control group at day 21...Mean blood oxygen saturation for the VYN201 1 mg/ml group was 92.4% at day 21, an 8.8% improvement compared to the placebo group (83.6%). Mean blood oxygen saturation for the untreated and unstimulated control group was 95.2%....Treatment with VYN201 1 mg/ml resulted in a 51.8% mean improvement in functional lung volume compared to animals receiving placebo treatment."

Preclinical • Idiopathic Pulmonary Fibrosis

VYNE Therapeutics Announces First Vitiligo Patient Dosed in Phase 1a/b Clinical Trial of Novel BET Inhibitor VYN201 (GlobeNewswire) - "VYNE Therapeutics...announced that the first vitiligo patient has been dosed in a Phase 1a/b clinical trial of VYN201. VYN201 is a locally administered, small molecule, pan-bromodomain and extra-terminal domain (BET) inhibitor that is being developed for the treatment of immuno-inflammatory diseases....'I’m pleased with the progress our team has made to advance this critical program, and we look forward to reporting topline data for both the Phase 1a and Phase 1b portions of the study in the first half of 2023.”'"

Trial status • Dermatology • Immunology • Vitiligo

VYNE Therapeutics Announces First Patent Granted for Novel BET Inhibitor Platform (GlobeNewswire) - "VYNE Therapeutics...announced that GB Patent No. 2597228 entitled 'Compounds Comprising N-Methyl-2-Pyridone, And Pharmaceutically Acceptable Salts' has been granted by the United Kingdom’s Intellectual Property Office. This granted patent covers the compound in VYNE’s VYN201 program and has a 20-year term that will expire in April 2040. This newly issued patent is derived from The University of Dundee’s PCT application No. WO 2020/216779, which was filed nationally in multiple jurisdictions, and is exclusively licensed to Tay Therapeutics Limited and sublicensed to VYNE."

Patent • Dermatology • Immunology