BioCorRx Begins Recruitment for Clinical Trial of BICX104, an Implantable Naltrexone Pellet for the Treatment of Opioid Use Disorder
BioCorRx Inc. (OTCQB: BICX) has initiated the recruiting and enrollment process for its first-in-human clinical trial of BICX104, a biodegradable naltrexone pellet aimed at treating opioid use disorder (OUD). This Phase 1, open-label study will assess the pharmacokinetics and safety of BICX104 against a marketed naltrexone injection. The trial will be conducted at the Orange County Research Center, led by Dr. Joel M. Neutel. The company enjoys active IND status and FDA acceptance for a 505(b)(2) pathway, potentially allowing for dual indication for OUD and Alcohol Use Disorder (AUD).
- Initiation of first-in-human clinical trial for BICX104, an innovative treatment for opioid use disorder.
- Collaboration with the National Institute on Drug Abuse (NIDA) enhances credibility and potential funding.
- Active Investigational New Drug (IND) status and FDA approval for 505(b)(2) pathway indicates regulatory progress.
- None.
ANAHEIM, CA, April 27, 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 it has begun the recruiting and enrollment process for its first-in-human 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 R&D subsidiary.
The BICX104 clinical study is a Phase 1, 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. The study will be led by Dr. Joel M. Neutel M.D., Director of Research at the Orange County Research Center (OCRC), located in Tustin, CA. Interested participants can reach out directly to OCRC on their website below. Information about the study can also be found at www.clinicaltrials.gov under NCT number 04828694.
“This is an extremely important milestone as it marks the next phase of development for BICX104,” said Brady Granier, President, Director of BioCorRx Inc. and CEO of BioCorRx Pharmaceuticals Inc. “This study will help evaluate the pharmacokinetics and safety of BICX104 compared to another marketed naltrexone product. We believe that better compliance to naltrexone therapy will ultimately lead to better patient outcomes. We strive to enroll all subjects as soon as possible and look forward to providing progress updates as they become available.”
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 Orange County Research Center (OCRC)
OCRC is a therapeutically-focused early and late stage clinical development site offering a 50+ bed PK unit and a Phase II-IV clinic. Enrolling, managing and executing cutting edge clinical research protocols for large pharmaceutical and mid-sized biotechnical companies, OCRC has developed into a premier, patient-centered provider offering therapeutic expertise across an impressive therapeutic spectrum including but not limited to Cardiovascular Disease, Dermatology, Diabetes, Hypertension, Liver Disease, Nephrology and Wound Healing.
For more information, please visit www.ocresearchcenter.com
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.
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?
When did BioCorRx announce the start of the BICX104 clinical trial?
What is the study design for the BICX104 trial?
What are the potential indications for BICX104?
Where is the BICX104 clinical trial being conducted?
