Dyve Biosciences got FDA Approval for Phase 2 trial of its DYV-700 transdermal drug delivery trial. The study is a double blind used for the treatment of acute gout pain.
The study evaluates the efficacy of DYV-700 transdermal drug delivery in patients in a placebo-controlled and randomized clinical trial. The study aim to register 300 patients in USA across 20 centres with an aim to understand the efficacy for the treatment of acute gout pain.
As per reports, plans to start the target study will begin from the first quarter of 2020.
The drug is a topical cream with the consistency of a moisturizer or lotion. It is used on the limb of the affected joint three times per day that penetrates the skin, get into the joint space and change the pH environment in the joint, dissolving the crystals that cause pain for the patients.
Dyve CEO Dr. Ryan Beal told said in an interview. “We did it intentionally and believe in the science of what’s going on, but also wanted to expose it to trial centers across the U.S. so enrollment numbers naturally go up. It’s definitely a big step forward for us in terms of the clinical validation.”
He added, “The first trial we did is what got us excited about it, gout attacks will go beyond three days with the standard of care and we were seeing resolution in as quick as 30 minutes in many cases. That got our investigators very excited.”
As per news reports, around 50% reductions were visible in gout attack timing and reduction of pain within short period. Data also suggest that a catalyst in moving forward with DYV-700 was the enthusiastic reaction of rheumatologists.
Many analysts and company’s CEO suggest that the phase 2 FDA clearances will be big step of company R&D work that focuses on gout and melasma.