BioCorRx Reports Business Update for the Second Quarter of 2023
On Track to Meet 2023 Regulatory Milestones
ANAHEIM, CA, Aug. 14, 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 June 30, 2023, and reported on recent corporate developments.
Lourdes Felix, CEO, CFO, and Director of BioCorRx Inc., commented, “We are continuing to realize our vision and progressing BICX104 along the regulatory pathway. On the heels of positive interim safety and pharmacokinetic (PK) data last quarter, we recently announced the submission of the fast track application to the U.S. Food and Drug Administration (“FDA”). The purpose of the FDA Fast Track designation is to accelerate the review process of drugs to treat serious conditions and fill an unmet medical need. It is designed to expedite the development and review of drugs which may demonstrate a substantial improvement over other available drugs. It can lead to an accelerated approval and priority review if relevant criteria are met. We expect to receive a response to the FDA Fast Track application sometime next month. Separately, we are also preparing to apply for expanded access to the FDA, which would allow for compassionate use of BICX104 sooner than full FDA approval. In certain settings, expanded access can provide a pathway for patients that are in immediate need to gain access.”
“In addition to executing our plans for our lead product candidate BICX104 outlined at the beginning of the year, the Company achieved an increase in revenue during the second quarter of 2023. While at the same time, we reduced our total operating expenses by over $400,000, by continuing to carefully manage expenses, as compared to the same period last year. Overall, we remain encouraged by the outlook for the business and look forward to providing additional operational and regulatory updates in the near future.”
A copy of the Company’s quarterly report on Form 10-Q for the second quarter ended June 30, 2023, has been filed with the Securities and Exchange Commission and posted on the Company’s website at https://ir.biocorrx.com/.
BICX104 is a biodegradable, long-acting subcutaneous pellet of naltrexone for the treatment of Opioid Use Disorder “OUD” being developed with the goal of improving patient compliance to naltrexone therapy compared to other marketed treatments. In Phase I, open-label, single-center study in two parallel groups of randomized healthy volunteers to evaluate the PK and safety of BICX104 and the once-a-month intramuscular naltrexone injection (Vivitrol), BICX104 was well tolerated with no serious adverse events and achieved 84 days of therapeutic naltrexone plasma concentrations. BICX104 is being developed under BioCorRx Pharmaceuticals Inc., the Company’s majority-owned clinical-stage pharmaceutical subsidiary.
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.
OUD is a chronic disorder, with serious potential consequences including disability, relapses, and death. Opioids, used medically for pain relief, have analgesic and central nervous system depressant effects as well as the potential to cause euphoria with an overpowering desire to use opioids despite the consequences. OUD can involve misuse of prescribed opioid medications, use of diverted opioid medications or illicitly obtained heroin. OUD is typically a chronic and relapsing illness, that is associated with significantly increased rates of morbidity and mortality.
According to the National Institute of Health opioid use disorder and opioid addiction remain at epidemic levels in the US and worldwide. Three million US citizens and 16 million individuals worldwide have had or currently suffer from OUD. More than 500,000 in the United States are dependent on heroin.
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 the 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 August 14, 2023