THOUSAND OAKS, Calif.--(BUSINESS WIRE)--Dyve Biosciences, a research and drug development company using proprietary science to create novel therapeutics, today announced it has enrolled its first patient in TARGETS, a Phase 2 clinical study of DYV-700, the company’s topically administered therapeutic being developed as a treatment for acute gout.
Lisa Misell, Ph.D., Vice President of Clinical and Medical Affairs at Dyve said, “DYV-700 is the first therapeutic using our proprietary science to reach Phase 2 and we’re thrilled to have our first patients enrolled. This is a significant milestone for Dyve and represents a potential breakthrough for patients who suffer from acute gout flares. In our pilot trial, we were encouraged to see highly significant (p=0.004) reductions in pain during acute gout attacks and nearly 50% shorter attacks compared to control. The Phase 2 trial is aimed to support these initial results and advance DYV-700 down the development path towards FDA approval.”
TARGETS (NCT04130204) is a double-blinded, placebo-controlled, randomized, Phase 2 clinical study to evaluate the efficacy of DYV-700 applied topically to patients with an acute gout flare. TARGETS is designed to enroll 300 subjects across 20 trial centers in the U.S. The primary objectives are to evaluate the efficacy of DYV-700, defined as a reduction in pain intensity and a reduction in the duration of the gout attack. The clinical study protocol was developed in partnership with the Dyve Scientific Advisory Board, members of which are listed on the company’s website.
Dyve Biosciences CEO Ryan Beal M.D., added, “I’m thrilled to see our science behind a potential new therapeutic option for gout patients and thank our advisors and investigators for their enthusiastic support. Dyve’s science is enabling a first-in-class mechanism of action which could bring quick, more substantial pain relief to millions of gout patients. This is an important milestone and just the tip of the iceberg in terms of how our science will be applied to other molecules and other disease states.”
About Dyve Biosciences
Dyve Biosciences is a drug development company using proprietary science to create novel therapeutics. The company is rapidly developing a strong pipeline across a broad range of therapeutic areas based around its proprietary science. Dyve’s most advanced asset, DYV-700, is in Phase 2 for the treatment of acute gout using a first-in-class mechanism of action enabled by Dyve’s science. The company has PK data demonstrating injection-like delivery across a diverse set of molecules. For more information please visit dyvebio.com.