Dyve Biosciences received FDA clearance to begin a Phase 2 study of its DYV-700 transdermal therapeutic for the treatment of acute gout pain.
Thousand Oaks, Calif.-based Dyve said it plans to begin the Targets study in the first quarter of 2020. It is slated to be a double-blind, placebo-controlled, randomized clinical trial to evaluate the efficacy of DYV-700 in patients with acute gout flare.
The Targets trial is set to enroll 300 subjects across 20 centers in the U.S. with the primary objective of observing DYV-700’s efficacy in reducing pain intensity and duration of pain. Dyve CEO Dr. Ryan Beal told MassDevice last week that specific marks have not yet been set, but he is looking for a 50% reduction in pain.
“It’s on the large side for gout,” Beal 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.”
A pilot study revealed a nearly 50% reduction in gout attack duration as meaningful and significant pain reduction was observed in minutes, not days, according to a news release. Beal said a catalyst in moving forward with DYV-700 was the enthusiastic reaction of rheumatologists when they were showed the data.
“The first trial we did is what got us excited about it,” Beal said. “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.”
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.
Beal said the company has focused most of its time on treatments for gout and melasma, which is hormone-induced hyper-pigmentation during pregnancy, the latter of which is being considered for trials but is behind gout in Dyve’s pecking order. The company is doing R&D work with other targets, but is focusing on gout and melasma.
The CEO believes the company’s latest FDA clearance for the Phase 2 trial will be a big step in the right direction for the transdermal treatment and for gout treatment in general.
“For acute gout attacks, there’s been very little innovation,” Beal said. “Patients have trouble walking but are dealing with pain for two, five, maybe seven days. We’re just optimistic about what we can do for those patients, changing what can be days of pain to hours or minutes of pain.”