BioCorRx Provides Business Update for the First Quarter of 2023
ANAHEIM, CA, May 16, 2023 (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 provided a business update for the three months ended March 31, 2023 and reported on recent corporate developments.
Lourdes Felix, CEO, CFO and Director of BioCorRx Inc., commented, “During the quarter, we reported interim positive safety and pharmacokinetic (PK) results for the Phase I clinical trial of BICX104, an implantable biodegradable naltrexone pellet for the treatment of opioid use disorder (OUD), at the 4th Annual NIH HEAL Initiative Investigator Meeting. Notably, data showed that BICX104 was generally well-tolerated, with no serious adverse events, and provided subjects with 84 days of therapeutic levels of naltrexone. This confirms our expectations that BICX104 naltrexone pellets can be safely administered without significant risk. Based on these results, we are preparing submissions for fast-track designation and expanded access. We hope to get both submitted in the second quarter of 2023 pending final preparation by our regulatory team.”
“We saw an increase in revenue in the first quarter of 2023. We also continue to carefully manage expenses and reduced selling, general and administrative expenses by 15%. Additionally, we appointed Mr. Harsha Murthy to the Board of Directors. Mr. Murthy is an experienced pharmaceuticals and finance executive and his deep expertise in business and finance across biotech and large pharmaceutical companies will be invaluable as we continue to advance on our business development initiatives.”
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.
A copy of the Company’s quarterly report on Form 10-Q for the first quarter ended March 31, 2023 has been filed with the Securities and Exchange Commission and posted on the Company’s website at https://ir.biocorrx.com/.
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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