Revive Therapeutics (RVV.C) intends to advance its product pipeline to human clinical studies in regions where its products have already acquired regulatory approval and are approved for sale.
The company’s chief product is Bucillamine, a drug that’s been active in Japan in Korea for over three decades in the fight against rheumatoid arthritis and is presently being given some serious attention for its potential role in treatment for infectious diseases, including COVID-19.
“We have strengthened our scientific and clinical team that will allow us to pursue the clinical development of Bucillamine in the potential treatment of not only COVID-19 but also other infectious diseases and we are seeking to advance Bucillamine for COVID-19 towards a potential U.S. FDA phase 2 clinical study and a clinical study in one of the APAC countries,” said Michael Frank, Revive’s chief executive officer.
Revive already has a patent with the U.S. Patent and Trade Mark Office called “Use of Bucillamine in the Treatment of Infectious Diseases” (Serial No. 62/991,996).
The company received a investigational new drug (IND) application for Bucillamine granted by the U.S. Food and Drug Administration (FDA) for the treatment of acute gout flares in a phase 2 study, and the company has explored the drug’s use in the treatment of cystinuria, where it has received FDA orphan drug status and its IND also accepted to conduct a phase 2 study in the U.S.
“Revive has built a robust product pipeline that has a particular focus on infectious diseases and rare disorders and is discovering and developing new therapeutic uses of drugs such as Bucillamine, Psilocybin and cannabidiol. We are steadily advancing our product development programs that will unlock the potential value of Revive and we are continuing to expand our product pipeline in infectious diseases and rare disorders,” said Frank.
The company is taking advantage of its experience with the FDA regulatory and clinical processes with Bucillamine to advance its clinical initiatives for the use of the drug as a potential treatment of COVID-19 and other infectious diseases. Revive has strengthened its scientific and clinical development team to realize the full potential commercial value of the company’s product pipeline, while unlocking the full potential of Bucillamine for infectious diseases.
They’ve brought on Dr. David Boulware, MD, MPH, who is an intentionally recognized expert in infectious diseases and a professor of medicine in the division of infectious diseases and international medicine from The University of Minnesota. He is presently a principle investigator of a globally recognized COVID-19 clinical trial.
Revive has also strengthened its team by retaining Pharm-Olam LLC, a company with proven clinical experience in infectious diseases, including over 100 completed clinical studies in approximately 19,000 patients at over 2,000 sites. They will serve as the company’s contract research organization to advance the Bucillamine study specifically for COVID-19 and potentially other diseases.
The company is busy putting the finishing touches on its regulatory package and clinical study plan for Bucillamine and will submit for regulatory approval by submitting an IND. Revive will also look to the Asian-Pacific regions for clinical investigation, with specific targets of Japan and South Korea.
Full disclosure: Revive Therapeutics is an equity.guru marketing client.