Revive Therapeutics Ltd. announced the initiation of a Phase II-A clinical study in patients with gout in the U.S. The initiation of the Phase II-A study for gout follows Revive's recent announcement that the U.S. Food and Drug Administration has accepted the company's Investigational New Drug Application ("IND") to commence a clinical trial for REV-002 (Bucillamine) for the treatment of gout. The Phase II-A study is an open-label, multicenter, active-controlled, parallel-group clinical trial designed to evaluate the safety and efficacy of two doses of Bucillamine compared with low-dose Colchicine in the treatment of patients with acute gout flare. The study will be performed in a total of sixty-six eligible patients, who are confirmed with qualifying gout flare, and who will be randomized in a 1:1:1 allocation ratio to Bucillamine low dose, Bucillamine high dose or Colchicine treatments over a seven day treatment period.

The primary efficacy endpoint will be the proportion of patients who responded to treatment. Treatment responders are defined as a 50% reduction in target joint pain score from baseline at 72 hours post dose without using rescue drug. The secondary efficacy endpoint will be the proportion of patients with 50% reduction in target joint pain score from baseline at 24 hours and 48 hours post dose without using rescue drug.

Exploratory endpoints will also include measurement parameters in uric acid, C-reactive protein, Interleukin-1beta, and Interlleukin-6.