Dyve Biosciences announced today that it enrolled its first patient in the Phase 2 clinical study of its DYV-700 topically administered therapeutic for acute gout treatment.
Thousand Oaks, Calif.–based Dyve won FDA clearance to begin the Targets Phase 2 trial in December 2019. The double-blind, placebo-controlled, randomized clinical trial is set to evaluate the efficacy of DYV-700 in patients with acute gout flare.
The company plans to enroll 300 subjects across 20 centers in the U.S. as it seeks to evaluate the potential for reduction in pain intensity and duration in the gout attacks.
Dyve’s therapeutic is a topical cream with the consistency of a moisturizer or lotion. The patient is supposed to apply it to the limb of the affected joint three times per day and the drug is designed to penetrate the skin, get into the joint space and change the pH environment in the joint, dissolving the crystals that cause pain. A previously conducted pilot study revealed a nearly 50% reduction in gout attack duration as meaningful and significant pain reduction was observed in minutes, not days.
“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 Biosciences CEO Dr. Ryan Beal said in a news release. “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.”