BioCorRx Announces Completion of Treatment Phase of Study Subjects and Preliminary Safety Data from Phase I Clinical Trial of BICX104, an Implantable Naltrexone Pellet for the Treatment of Opioid Use Disorder
ANAHEIM, CA, Jan. 19, 2023 (GLOBE NEWSWIRE) -- via NewMediaWire – BioCorRx Inc. (OTCQB: BICX) (the “Company”), a developer and provider of innovative treatment programs for substance use and related disorders, today announced an update from 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.
BICX104 is a biodegradable, long-acting subcutaneous pellet of naltrexone for the treatment of OUD being developed with the goal of improving patient compliance to naltrexone therapy compared to other marketed pharmacotherapies. 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 (PK) and safety of BICX104 implantable subcutaneous naltrexone pellets and the marketed once-a-month intramuscular depot naltrexone injection, Vivitrol.
Information about the study can also be found at www.clinicaltrials.gov under NCT number 04828694.
Dr. Andrew Mallon, CSO and Grant Principal Investigator on the trial states, “All study participants have completed their respective treatment phase and are now in the follow-up phase, which is scheduled to end on March 22, 2023, when the last enrolled participants have their final, day 168 follow-up visit. To date, the study site has not observed any serious adverse events or unexpected adverse events. Adverse events were largely limited to local responses to the implantation which appear transient. Interim safety data demonstrates that BICX104 is generally well-tolerated. Final PK data in all subjects from start of treatment through follow up is expected toward the end of the study when all samples have been collected and analyzed, but we plan to have complete PK data on the treatment phase later this month.”
“Although we await the complete PK data, we are excited and pleased to continue to expeditiously advance BICX104 development with the preliminary safety data received thus far. We look forward to providing the complete treatment-phase PK data in the coming weeks,” said Brady Granier, President, Director of BioCorRx Inc. and CEO of BioCorRx Pharmaceuticals Inc.
BICX104 is being developed through a cooperative agreement with the National Institute on Drug Abuse (NIDA), part of the National Institutes of Health (NIH), under award number 3UH3DA047925-03S, funded by the Helping to End Addiction Long-term Initiative, or NIH HEAL Initiative. This award is subject to the Cooperative Agreement Terms and Conditions of Award as set forth in RFA DA-19-002 entitled, Development of Medications to Prevent and Treat Opioid Use Disorders and Overdose (UG3/UH3) (Clinical Trial Optional).
The Helping to End Addiction Long-term® Initiative, or NIH HEAL Initiative®, is an aggressive, trans-NIH effort to speed scientific solutions to stem the national opioid public health crisis. Launched in April 2018, the initiative is focused on improving prevention and treatment strategies for opioid misuse and addiction, and enhancing pain management. For more information, visit: https://heal.nih.gov.
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.
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Released January 19, 2023