ANAHEIM, CA, April 02, 2024 (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 year ended December 31, 2023, and reported on recent corporate developments.
Lourdes Felix, CEO, CFO, and Director of BioCorRx Inc., commented, “In 2023, we made significant strides in advancing the Phase I clinical trial of BICX104, an implantable biodegradable naltrexone pellet designed for treating opioid use disorder (OUD). The Phase I trial yielded positive safety and pharmacokinetic (PK) results, indicating that BICX104 was generally well-tolerated with no serious adverse events. Subjects experienced therapeutic levels of naltrexone for an average of 84 days, aligning with our expectations. These findings confirm our expectations of the administration of BICX104 naltrexone pellets, without significant associated risks. We believe that the sustained release of naltrexone by BICX104 holds promise in significantly reducing opioid overdose deaths.
“Recently, we announced that the Company’s majority owned subsidiary BioCorRx Pharmaceuticals received a 3-year grant totaling approximately $11 million from the National Institute on Drug Abuse (NIDA), a division of the National Institutes of Health (NIH). This grant is designated for the development of BICX104, a subcutaneous, long-duration naltrexone implantable pellet, either as a standalone treatment or in combination with bupropion, for addressing methamphetamine use disorder (MUD). MUD poses a significant public health challenge, with far-reaching impacts on individuals, families, and communities nationwide. Currently, there are no approved medications specifically for MUD, and the demographic at risk of methamphetamine-involved overdose deaths continues to broaden. This funding will greatly accelerate our research efforts aimed at developing BICX104, either as a standalone therapy or combined with bupropion, for effectively treating MUD.
"Furthermore, we remain confident and vigilant in managing our expenses. We successfully decreased our total operating expenses by over $1.0 million for the year ending December 31, 2023, compared to the previous year. Overall, we are optimistic about the business outlook and look forward to continuing to develop medicines. We remain sharply focused on executing our strategic priorities to create significant value for shareholders and anticipate sharing further operational and regulatory updates soon,” concluded Ms. Felix.
A copy of the Company’s annual report on Form 10-K for year-ended December 31, 2023, has been filed with the Securities and Exchange Commission and posted on the Company’s website at https://ir.biocorrx.com/.
About BICX104
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, an 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.
Research reported in this publication was supported by the National Institute On Drug Abuse of the National Institutes of Health under Award Number U01DA059994 and UH3DA047925. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.
About MUD
Research has shown that methamphetamine is a highly addictive stimulant and one of the most misused stimulant drugs in the world. Some of the side effects of MUD are severe dental problems, memory loss, aggression, psychotic behavior, and damage to the cardiovascular system. In 2022 the National Survey on Drug Use and Health reported that more than 16.6 million people used methamphetamine at least once during their lifetime.
About OUD
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.
About BioCorRx Inc.
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.
Forward-Looking Statements
This press release contains 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.
BioCorRx Inc.
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