ANNOUNCES INITIATION OF A PHASE 2 STUDY OF REV-004 (BUCILLAMINE) IN CYSTINURIA
Revive Therapeutics Ltd. (RVV.V) has initiated a phase II clinical study in patients with cystinuria in the United States. The initiation of the phase II clinical study for cystinuria follows Revive's recent announcement that the U.S. Food and Drug Administration has accepted the company's investigational new drug application to commence a clinical trial for REV-004 (bucillamine) for the treatment of cystinuria. The company received U.S. FDA orphan designation status for the use of bucillamine for the treatment of cystinuria.
The Phase II study is the first clinical investigation of REV-004 in patients with cystinuria.;Designed as a multicenter, open-label, sequential dose escalation trial, eligible patients will be treated over 7-days with follow-up for safety of an additional 7-days. The study will be performed in up to thirty patients. The primary outcome measures will be the incidence of treatment-emergent adverse events (Safety and Tolerability). The secondary outcome measures are 24-hour urine cystine excretion and 24-hour urine cystine capacity. It is believed that REV-004 will require a lower effective dose, which in turn may result in less adverse events and better patient compliance than other thiol drugs currently approved for cystinuria.
"The initiation of the Phase II study marks another important clinical milestone for Revive," says Fabio Chianelli, President of Revive. "I am very excited to advance our cystinuria treatment into human clinical trials in the U.S., and we look forward to updating the investment and medical communities on our developments as they arise."
Cystinuria is an inherited autosomal recessive disease that is characterized by high concentrations of the amino acid cystine in the urine, leading to the formation of cystine stones in the kidneys, ureter, and bladder.
About REV-004 (Bucillamine)
Bucillamine is a potent thiol donor with two thiol groups which is believed to undergo a thiol-disulfide exchange with cystine to form a soluble bucillamine-cysteine compound which can be excreted in the urine, lowering the concentration of cystine to below the solubility limit (generally <250 mg/L) and preventing stone formation.
About Revive Therapeutics Ltd.
Revive Therapeutics Ltd. (TSX VENTURE:RVV)(OTCQB:RVVTF) is focused on the research, development and commercialization of novel treatments for serious and unmet medical needs by identifying and investigating potential drugs and plant-based therapies, such as cannabinoids, that may be repurposed for new indications, be delivered in a different way, combined with existing drugs, or be developed as new