BioCorRx Attended 4th Annual NIH HEAL Initiative Investigator Meeting; Shares Update on BICX104 Data
On February 23, 2023, BioCorRx Inc. (OTCQB: BICX) announced the presentation of interim data from its Phase I clinical trial of BICX104, a biodegradable implantable naltrexone pellet aimed at treating opioid use disorder (OUD). Dr. Andrew Mallon reported at the NIH HEAL Initiative Meeting that BICX104 effectively maintains therapeutic levels for up to three months with no serious adverse events observed. Interim safety results indicate good tolerability. The study, funded by the NIH HEAL Initiative, is expected to conclude by the end of March, with final data to follow. The Company anticipates progress towards FDA approval for this innovative treatment option.
- BICX104 demonstrates effective maintenance of therapeutic levels for up to 3 months.
- No serious adverse events reported, indicating a favorable safety profile.
- Study completion is expected by the end of March, with final data analysis to be provided.
- None.
ANAHEIM, CA, Feb. 23, 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, announced today that Dr. Andrew Mallon, CSO and Grant Principal Investigator on the Phase I clinical trial of BICX104, an implantable biodegradable naltrexone pellet for the treatment of opioid use disorder (OUD), attended and presented a poster on BICX104 interim data at the 4th Annual NIH HEAL Initiative Investigator Meeting, which was held February 21-22nd, 2023.
Dr. Andrew Mallon states, “We were excited to be able to present the complete treatment phase pharmacokinetic (PK) and safety data results of BICX104 to our colleagues at the National Institute on Drug Abuse (NIDA), part of the National Institutes of Health (NIH). The PK data indicate that BICX104 delivers up to 3 months of therapeutic levels, as desired. Additionally, and as previously announced, the study site has not observed any serious adverse events. Adverse events were largely limited to local responses to the implantation which appeared transient. Interim safety data demonstrates that BICX104 is generally well-tolerated. The study is scheduled to be completed at the end of March and final data will be analyzed and announced.”
“We are very happy with the interim results received. BICX104 has the potential to make a huge impact on substance use disorder treatment by providing treatment providers with another option in the limited arsenal currently available. We look forward to providing additional updates on progress toward FDA approval soon,” said Brady Granier, President, Director of BioCorRx Inc. and CEO of BioCorRx Pharmaceuticals Inc.
BICX104 which is being developed under BioCorRx Pharmaceuticals, Inc., the Company’s controlled clinical stage pharmaceutical company, 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 treatments. The BICX104 clinical study is a Phase I, open-label, single-center study in two parallel groups of randomized healthy volunteers to evaluate the 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.
BICX104 is being developed through a cooperative agreement with the NIDA, part of the NIH, under award number UH3DA047925, 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 NIH 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.
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 Engraver® 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 BIVC 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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