BioCorRx Provides 2021 Year-End Business Update
ANAHEIM, CA, April 01, 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 provided a year-end business update for 2021 and reported on recent corporate developments.
Lourdes Felix, CEO, CFO and Director of BioCorRx Inc., commented, “In 2021, we achieved a number of important milestones and accomplishments. During the second quarter of 2021, we received clearance from the U.S. Food and Drug Administration (FDA) to proceed to human trials for BICX104, a gradual release implantable pellet for opioid use disorder (OUD) being developed under the Company’s controlled subsidiary, BioCorRx Pharmaceuticals, Inc. BICX104 is being developed with the goal of improving patient compliance to naltrexone therapy compared to other marketed pharmacotherapies. Naltrexone binds to opioid receptors in the brain thereby blocking some of the effects of alcohol and opioids, as well as reduction of cravings. It can also eliminate or reduce the euphoric effects of these substances. We believe that better compliance to naltrexone therapy will ultimately lead to better patient outcomes.
“In September 2021, we were awarded approximately $3.5 million for the second phase of a grant which was awarded by the National Institute on Drug Abuse (NIDA), part of the National Institutes of Health (NIH). This was a major milestone as this funding is non-dilutive and substantially covers our financial costs as we move through the FDA approval process. To date, we have received nearly $9.2 million of non-dilutive funding from NIH/NIDA which includes the award we received in September. In addition, we expanded our agreement with IriSys LLC, the San Diego-based contract development and manufacturing organization that was recently acquired by Recro. Under the expanded agreement, Recro will provide analytical validation services and cGMP manufacturing of registrational batches of BICX104 to support BioCorRx’s potential filing of a New Drug Application for BICX104 with the FDA.
“We are also building our intellectual property portfolio. In November 2021, we acquired a patent application from Calista Therapeutics which covers solid implant formulation for drug delivery. We believe this IP adds value to our portfolio, and we plan to explore its uses with our current formulations as well as with others in the implantable drug delivery space. Additionally, we filed a patent application related to BICX104 with the U.S. Patent and Trademark Office. Filing this patent application is another key milestone in our intellectual property strategy to build a global patent portfolio.
“Last month, we received Independent Institutional Review Board approval which marked a key step in beginning the first-in-human clinical trial of BICX104. We are looking forward to beginning the first-in human clinical trial of BICX104 which will assess longevity, safety, and tolerability of BICX104. Our goal is to quickly bring BICX104 to market to help people suffering from opioid use disorder. We are striving to begin the trial in the second quarter of 2022 barring any unforeseen delays.”
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).
A copy of the Company’s annual report on Form 10-K for the year-ended December 31, 2021 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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Released April 1, 2022