BioCorRx Inc (OTCQB:BICX), a provider of treatments for substance abuse disorders, announced Tuesday that development of its naltrexone implant has not been hampered by the coronavirus (COVID-19) pandemic.
Naltrexone is designed to decrease the desire to take opioids.
"We continue to advance BICX102, a sustained-release naltrexone implant for the treatment of opioid and alcohol use disorders, through the research and development pathway,” CEO Brady Granier said in a statement. “Over the summer, we entered into a Master Services Agreement with Charles River Laboratories Inc to begin conducting preclinical studies of BICX102.
“We do not anticipate any delay to the completion of the pivotal GLP preclinical study currently underway due to the current COVID-19 pandemic at this time. We believe we are still on track to submit our [Investigational New Drug] application to the US Food and Drug Administration later this year with the goal of starting human studies in early 2021.”
The Anaheim, California company received an infusion of cash from a US federal research institute earlier this year.
"We were also pleased to announce in January 2020 that we were awarded the additional non-dilutive $2.8 million grant by the National Institute on Drug Abuse (NIDA), part of the National Institutes of Health (NIH),” Granier said. “This is the second tranche from the total grant of approximately $5.7 million which we announced in 2019. This grant is expected to substantially cover our financial costs towards FDA approval.”
Elsewhere, other BioCorRX projects continue to advance, the company said.
"We also continue to move ahead with VDM-001, a new molecule being developed to reverse opioid overdose through our partnership with VDM Biochemicals Inc,” Granier said. "Preclinical studies are currently ongoing, and we anticipate having minimal delays due to COVID-19."
The company believes the drug, developed in partnership with VDM Biochemicals, could be an effective alternative to naloxone in reversing overdoses. Early preclinical data has shown that the effects of fentanyl use, which is responsible for thousands of deaths per year, may be prevented by VDM-001.
In the meantime, the company's other products remain available.
"Our BioCorRx Recovery and UnCraveRx programs both remain available to those treatment providers that need it for their patients," Granier said. “The mobile application portion of those programs can give patients and treatment providers a means of engaging during the Safer at Home orders around the country."
Contact Andrew Kessel at [email protected]
Follow him on Twitter @andrew_kessel