BioCorRx (OTC:BICX) announced today that it enrolled the last subject in the Phase I clinical trial of its BICX104 implant.
Anaheim, California-based BioCorRx designed BICX104 for the treatment of opioud use disorder (OUD). Its BioCorRx Pharmaceuticals company developed the implantable, biodegradable naltrexone pellet.
“We are pleased to have reached this significant milestone,” said Brady Granier, president and director of BioCorRx Inc. and CEO of BioCorRx Pharmaceuticals Inc. “We are currently in the process of collecting data and we expect to have interim data by the end of the year demonstrating safety and duration. … As the opioid epidemic continues to plague the nation, our purpose is to rapidly bring BICX104 to market and provide a truly effective treatment for those suffering from substance use disorders and their lethal consequences.”
The Phase I, open-label, single-center study evaluates two parallel groups of randomized healthy volunteers. BioCorRx looks to determine the pharmacokinetics and safety of BICX104 implantable subcutaneous naltrexone pellets. It also seeks to evaluate the marketed once-a-month intramuscular depot naltrexone injection, Vivitrol.
Dr. Joel Neutel, director of research at the Orange County Research Center (Tustin, California) is leading the study.
Granier said the company plans to add more subjects to complete the FDA-required clinical characterization of BICX104. This comes prior to seeking marketing approval, potentially in 2023.
BioCorRx develops BICX104 in collaboration with the National Institute on Drug Abuse (NIDA), part of the National Institutes of Health (NIH). It has an active FDA investigational new drug (IND) status.