11 December 2019 - - US-based topical skin penetration technology developer Dyve Biosciences, Inc. has received clearance from the US Food and Drug Administration to proceed with a Phase 2 trial of DYV-700, the company's topically administered therapeutic being developed to reduce the pain and duration of an acute gout flare, the company said.

Dyve intends to initiate the Phase 2 trial, the TARGETS Study (NCT04130204), in the first quarter of 2020.

TARGETS is a double-blind, placebo-controlled, randomized, clinical trial 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 US The primary objectives are to evaluate DYV-700 efficacy, 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. The company plans to provide additional study details following its initiation.

In the US, gout affects over 10m people with more than 40% of patients having two or more attacks per year. The number of gout patients is growing due to poor chronic gout management and the condition's links to hypertension, renal failure, diabetes, and obesity.

In addition, the standard of care for an acute gout flare has been the same for nearly 40 years, works slowly, and is associated with GI distress in ~23% of patients.

Dyve's technology allows an intuitive topical application to rapidly deliver DYV-700 through the skin and quickly dissolve pain-inducing monosodium urate crystals in the joints.

In a pilot study presented at the American College of Rheumatology annual meeting in Atlanta in November, investigators showed that DYV-700 provides meaningful and significant (p=0.004) pain reduction in minutes, not days, and reduced gout attack duration by nearly 50%. The treatment was safe and well tolerated.

The initial clinical data along with encouraging evidence from pharmacokinetic, preclinical, and proof of concept studies from other drug candidates, show that Dyve's technology has broad applicability and has the potential to help patients across multiple therapeutic areas.

Dyve Biosciences has developed a topical skin penetration technology.

The innovative approach enables drugs to be transported from the surface of the skin into the blood with needle-like speed and pill-like efficiency.

Dyve said it has advanced clinical programmes in gout and melasma and a robust pre-clinical and clinical data set across a broad set of molecules.