Up to 30 patients with cystinuria – a genetic disease that causes kidney and bladder stones – will be treated with REV-004, or Bucillamine as it is also known, for seven days.
Patients will then be monitored for another seven days as a safety precaution.
The primary aim of the trial is to ass the safety and tolerability of the drug, while a secondary outcome will assess the excretion of cystine in the patients’ urine.
“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 US, and we look forward to updating the investment and medical communities on our developments as they arise.”
The US Food & Drug Administration (FDA) accepted Revive’s investigational new drug application (IND) last summer which paved the way for the clinical trial.
The FDA also granted REV-004 orphan designation status as a treatment for cystinuria.
Cystinuria is a hereditary disease that causes high concentrations of the amino acid cysteine in the urine, which leads to the formation of cystine stones in the kidneys, ureter and bladder.
It is hoped that Bucillamine will mix with the cystine and lower the concentration to make the cystine soluble and prevent the formation of stones. This new soluble compound can then be excreted in the urine.
Revive shares closed at C$0.12 on Monday.
Story by ProactiveInvestors