FDA accepts Revive’s IND for Phase 2 bucillamine study
The FDA has accepted an IND from Revive Therapeutics (OTCQB:RVVTF; TSX-V:RVV) for a Phase 2 clinical study of bucillamine for the treatment of cystinuria.
"This marks another significant milestone for Revive and we look forward to initiating this Phase 2 study shortly," Fabio Chianelli, president, said in a statement.
Cystinuria is a rare autosomal recessive genetic disorder that causes high levels of cystine in the urine, causing kidney stones to form. The resulting kidney stones are often large and recurrent and lead to significant morbidity and sometimes loss of kidney function. There are between 10,000 and 12,000 patients affected with cystinuria in the U.S. The worldwide prevalence is about one-in-7,000.
The company received FDA orphan designation status for the use of bucillamine for the treatment of cystinuria.