BioCorRx Completes Final Subject Enrollment in Phase I Clinical Trial of BICX104, an Implantable Naltrexone Pellet for the Treatment of Opioid Use Disorder

Rhea-AI Summary

BioCorRx (OTCQB: BICX) has enrolled the last subject in its Phase I clinical trial for BICX104, a biodegradable naltrexone pellet aimed at treating opioid use disorder (OUD). The trial, led by Dr. Joel M. Neutel, will evaluate the safety and pharmacokinetics of BICX104 compared to the monthly injection Vivitrol. Interim data is expected by year-end, with plans to add more subjects for FDA-required clinical characterization, targeting potential marketing approval in 2023. The study is conducted in collaboration with the National Institute on Drug Abuse.

Positive

• Enrollment of last subject in Phase I trial for BICX104, indicating progress in drug development.
• Interim data expected by the end of the year, which may demonstrate safety and efficacy.
• Collaboration with National Institute on Drug Abuse enhances credibility and support for the trial.
• Possibility of dual indication for OUD and Alcohol Use Disorder could expand market opportunities.

Negative

• None.

ANAHEIM, CA, Oct. 13, 2022 (GLOBE NEWSWIRE) -- via NewMediaWire – BioCorRx Inc. (OTCQB: BICX) (the “Company”), a developer and provider of innovative treatment programs for substance abuse and related disorders, today announced that the last subject has been enrolled in the Phase I clinical trial of BICX104, an implantable biodegradable naltrexone pellet for the treatment of opioid use disorder (OUD), which is being developed under BioCorRx Pharmaceuticals, Inc., the Company’s controlled clinical stage pharmaceutical company.

“We are pleased to have reached this significant milestone,” said Brady Granier, President, 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. We plan to add additional subjects to complete the FDA-required clinical characterization of BICX104 prior to seeking marketing approval potentially in 2023. 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 BICX104 clinical study is a Phase I, open-label, single-center study in two parallel groups of randomized healthy volunteers to evaluate the pharmacokinetics and safety of BICX104 implantable subcutaneous naltrexone pellets and the marketed once-a-month intramuscular depot naltrexone injection, Vivitrol. The study is led by Dr. Joel M. Neutel M.D., Director of Research at the Orange County Research Center (OCRC), located in Tustin, CA. Information about the study can also be found at www.clinicaltrials.gov under NCT number 04828694.

BICX104 is being developed in collaboration with the National Institute on Drug Abuse (NIDA), part of the National Institutes of Health (NIH), under RFA DA-19-002, “Development of Medications to Prevent and Treat Opioid Use Disorders and Overdose (UG3/UH3) (Clinical Trial Optional).” The Company has an active Investigational New Drug (IND) status, and the FDA has deemed the 505(b)(2) abbreviated pathway acceptable, as well the opportunity to seek eventual dual indication on the product for OUD and Alcohol Use Disorder (AUD).

About BioCorRx

BioCorRx Inc. (OTCQB: BICX) is an addiction treatment solutions company offering a unique approach to the treatment of substance use and other related disorders. Beat Addiction Recovery is a substance use disorder recovery program that typically includes BioCorRx's proprietary Cognitive Behavioral Therapy (CBT) modules along with peer support via mobile app along with medication prescribed by an independent treating physician under their discretion. The UnCraveRx® Weight Loss Program is also a medication assisted weight loss program that includes access to concierge on-demand wellness specialists: nutritionists, fitness experts and personal support from behavioral experts; please visit www.uncraverx.com for more information on UnCraveRx®. The Company also controls BioCorRx Pharmaceuticals, a clinical stage drug development subsidiary currently seeking FDA approval for BICX104, an implantable naltrexone pellet for treatment of alcohol and opioid use disorders. For more information on BICX and its subsidiary pipeline, please visit www.BioCorRx.com.

Safe Harbor Statement

The information in this release includes forward-looking statements. These forward-looking statements generally are identified by the words "believe," "project," "estimate," "become," "plan," "will," and similar expressions. These forward-looking statements involve known and unknown. risks as well as uncertainties. Although the Company believes that its expectations are based on reasonable assumptions, the actual results that the Company may achieve may differ materially from any forward-looking statements, which reflect the opinions of the management of the Company only as of the date hereof.

BioCorRx Inc.
investors@BioCorRx.com
714-462-4880

Investor Relations:
Crescendo Communications, LLC
212- 671-1020 x304
bicx@crescendo-ir.com

Media Contact
PhillComm Global
BioCorRx@PhillComm.Global
704-942-1557

FAQ

What is the purpose of the BICX104 clinical trial?

The BICX104 clinical trial aims to evaluate the safety and pharmacokinetics of an implantable biodegradable naltrexone pellet for treating opioid use disorder.

When will interim data from the BICX104 trial be available?

Interim data from the BICX104 trial is expected by the end of 2022.

What are the next steps for BICX104 following the trial?

Following the trial, additional subjects will be added to meet FDA requirements, with potential marketing approval sought in 2023.

Who is leading the BICX104 study?

The study is led by Dr. Joel M. Neutel, M.D., Director of Research at the Orange County Research Center.