VYNE Therapeutics Receives FDA Clearance for IND Application of VYN202

VYNE Therapeutics Receives FDA Clearance for IND Application of VYN202

By, Admin 8 May 2024

VYNE Therapeutics Receives FDA Clearance for IND Application of VYN202, a Unique BD2-Selective BET Inhibitor

Overview

VYNE Therapeutics Inc. (Nasdaq: VYNE) announced today that the U.S. Food and Drug Administration has cleared its Investigational New Drug application (IND) for VYN202, an oral BD2-selective BET inhibitor. This marks a significant advancement in the company's efforts to develop therapies for autoimmune diseases. David Domzalski, President and CEO of VYNE, expressed excitement about the potential of VYN202 as a treatment option.

Phase 1a Trial

  • The company plans to initiate a Phase 1a trial to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of VYN202 in healthy volunteers. 
  • This trial will include single ascending dose/multiple ascending dose (SAD/MAD) components and is expected to enroll approximately 64 subjects. 
  • Pending successful completion of Phase 1a, VYNE intends to move forward with Phase 1b trials targeting moderate-to-severe plaque psoriasis and adult-onset rheumatoid arthritis, with results anticipated in the latter half of 2025.

VYN202

  • VYN202 is an oral small molecule BD2-selective BET inhibitor designed to offer high selectivity, potency, and oral bioavailability. 
  • It differs structurally from VYNE's pan-BET inhibitor, VYN201, and is covered by distinct patent applications.

BET Proteins

  • BET proteins play a crucial role in gene transcription regulation through epigenetic interactions, particularly in modulating B and T cell activation and inflammation. 
  • BET inhibitors hold promise for addressing various immuno-inflammatory and fibrotic diseases by blocking pro-inflammatory cytokine transcription, with potential applications in myeloproliferative neoplastic disorders.

Optimize Your trial insights with Clival Database.

Are you exhausted from the uncertainty of trial insights pricing? Clival Database ensures the clarity in the midst of the global scenario for clinical trials to you.

Clival Database is one of the best databases that offers an outstanding number of clinical trial data in terms of 50,000+ molecules and from primary regulatory markets as well as new entrants like Indian and Chinese markets.

With Clival, you get accurate positioning of historical sales data, patent database, company profiling, safety & efficacy, and prediction of launch of new innovative molecules helping you to align your research and driving down the cost.

To add value, we further break down our analytics for you so that improving your operational effectiveness; optimizing your clinical trials; and offering you accurate and high-quality data at lowest possible prices becomes possible.

Elevate your trial success rate with the cutting-edge insights from Clival database.

Check it out today and make more informed sourcing decisions! Learn More!