ANAHEIM, Calif., April 01, 2022 (GLOBE NEWSWIRE) — via NewMediaWire — BioCorRx Inc. (OTCQB: BICX) (the “Company”)a developer and provider of innovative treatment programs for addiction and related disorders, today provided an update on its 2021 year-end activities and reported on recent company developments.
Lourdes Felix, CEO, CFO and Director of BioCorRx Inc., said, “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 with human trials for BICX104, an implantable sustained-release lozenge for the disorder related to the use of opioids (OUD) being developed under the company’s controlled subsidiary, BioCorRx Pharmaceuticals, Inc. BICX104 is being developed with the goal of improving adherence to naltrexone treatment compared to others marketed drug therapies. Naltrexone binds to opioid receptors in the brain, thereby blocking some of the effects of alcohol and opioids, as well as reducing food cravings. It can also eliminate or reduce the euphoric effects of these substances. We believe that better adherence to naltrexone therapy will ultimately lead to better patient outcomes.
“In September 2021, we received approximately $3.5 million for the second phase of a grant that was awarded by the National Institute on Drug Abuse (NIDA), which is part of the National Institutes of Health (NIH). This was a significant milestone as this funding is non-dilutive and largely covers our financial costs as we progress through the FDA approval process. To date, we have received nearly $9.2 million in non-dilutive funding from NIH/NIDA, which includes the award we received in September. Additionally, we extended our agreement with IriSys LLC, the San Diego-based contract development and manufacturing organization that was recently acquired by Recro. As part of the expanded agreement, Recro will provide analytical validation and cGMP manufacturing services of registration 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 the formulation of solid implants for drug delivery. We believe this intellectual property adds value to our portfolio and we plan to explore its uses with our current formulations as well as others in the field of implantable drug delivery. Additionally, we have filed a patent application relating to BICX104 with the US Patent and Trademark Office. The filing of this patent application is another key step in our intellectual property strategy to build a global patent portfolio.
“Last month, we received approval from the Independent Institutional Review Board, which marked a key milestone in the initiation of the first-in-man clinical trial of BICX104. We look forward to commencing the first human clinical trial of BICX104 which will assess the longevity, safety and tolerability of BICX104. Our goal is to bring BICX104 to market quickly to help people with opioid use disorders. We are working to start 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 drugs to prevent and treat opioid use disorder and overdose (UG3/UH3) (clinical trial optional).” The company has active investigational new drug (IND) status and the FDA has deemed the 505(b)(2) abbreviated pathway acceptable, as well as the ability to pursue a potential dual indication on the product for OUD and the disorder related to alcohol consumption (AUD) .
A copy of the company’s annual report on Form 10-K for the fiscal 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 addiction 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 a mobile app as well as prescribed medications by an independent treating physician at his or her discretion. The UnCraveRx® Weight Loss Program is also a medication-assisted weight loss program that includes access to on-demand wellness specialists: nutritionists, fitness experts and expert personal support in behavior; please visit www.uncraverx.com for more information on UnCraveRx®. The Company also controls BioCorRx Pharmaceuticals, a clinical-stage drug development subsidiary that is currently seeking FDA approval for BICX104, an implantable naltrexone lozenge for the treatment of alcohol use disorder and opioids. For more information on BICX and its portfolio of subsidiaries, please visit www.BioCorRx.com.
Safe Harbor Statement
The information in this press release includes forward-looking statements. These forward-looking statements are generally identified by the words “believe”, “project”, “estimate”, “become”, “plan”, “will” and similar expressions. These forward-looking statements involve known and unknown matters. risks and 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 the forward-looking statements, which reflect the opinions of the Company’s management only as of the date hereof.
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