Verge Genomics Announces Positive Safety and Tolerability Data from the Phase 1 Clinical Trial of VRG50635, a Potential Best-in-Class Therapeutic for All Forms of ALS
- VRG50635 was safe and well tolerated in healthy adult volunteers after both single and repeated administration, with favorable pharmacokinetics showing relevant exposures with once-daily oral dosing
- Verge anticipates initiating a proof-of-concept study in ALS patients in Q4 2023
Excerpt from the Press Release:
SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–Verge Genomics, a clinical-stage biotechnology company transforming drug discovery using artificial intelligence and human data, today announced the completion of the Phase 1 clinical trial of VRG50635 in healthy adult volunteers. VRG50635 was dosed up to the maximum single and repeated doses planned, demonstrating a favorable safety, tolerability, and pharmacokinetic profile supportive of advancement into a proof-of-concept study in people with amyotrophic lateral sclerosis (ALS). Detailed results from the study will be presented at the upcoming European Network to Cure ALS (ENCALS) 2023 meeting being held in Barcelona, Spain from July 12-14, 2023.
VRG50635 is a potential best-in-class small molecule inhibitor of PIKfyve for treatment of ALS. PIKfyve is a new therapeutic target for ALS discovered using CONVERGE™, the company’s all-in-human, AI-powered platform. VRG50635 is one of the first drugs entirely discovered and developed from an AI-enabled platform to enter clinical trials, and was advanced from discovery to clinic in just four years.
“We are extremely encouraged by these initial results which highlight the favorable safety and tolerability profile of VRG50635, and further validate the novel approach that Verge has taken to identify novel targets for complex diseases with high unmet need using human disease tissues and rapidly advancing compounds into proof-of-concept trials,” said Diego Cadavid, M.D. Verge’s Chief Medical Officer.
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