BioCorRx Provides Business Update for the Second Quarter of 2021
BioCorRx Inc. (OTCQB: BICX) announced a significant milestone in its business update for Q2 2021. The company received FDA clearance to initiate human trials for BICX104, an implantable pellet designed for opioid use disorder. This trial aims to evaluate the safety, longevity, and tolerability of BICX104, with potential dual indications for both opioid and alcohol use disorders. Additionally, the firm expanded its Scientific Advisory Board with four new members to support the upcoming trials. The company emphasizes the urgent need for effective treatment amidst the ongoing drug overdose epidemic.
- FDA clearance for BICX104 to commence human trials.
- Potential for dual indication targeting opioid and alcohol use disorders.
- Expanded Scientific Advisory Board with experts to guide development.
- None.
ANAHEIM, CA, Aug. 16, 2021 (GLOBE NEWSWIRE) -- via NewMediaWire -- BioCorRx Inc. (OTCQB: BICX) (the “Company”), a developer and provider of advanced solutions in the treatment of substance use disorders, today provided a business update for the second quarter ended June 30, 2021 and reported on recent corporate developments.
Lourdes Felix, CEO, CFO and Director of BioCorRx Inc., stated, “During the quarter, we achieved a major milestone by receiving 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. The first in-human clinical trial will assess longevity, safety and tolerability of BICX104. Based on our previous pre-IND meeting with the FDA, the FDA deemed the abbreviated 505(b)(2) pathway acceptable, as well as provided us the opportunity to seek eventual dual indication on BICX104 for both OUD and Alcohol Use Disorder (AUD). We are expecting to be able to start the clinical trial of BICX104 later this year. Unfortunately, the COVID-19 pandemic has exacerbated the nation’s drug overdose epidemic, and people are in urgent need for treatment that is effective and safe, and we look forward to bringing our product to market.”
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).
“We also added four new members to our Scientific Advisory Board (SAB). We welcomed Dr. Jeff Witkin, a renowned research scientist with over 250 peer-reviewed publications and decades of drug research and development experience; Priya Jambhekar, a drug developer and entrepreneur with over 25 years of experience in worldwide regulatory drug development; Dr. Ashok Kumar, who brings 25 years of experience in drug delivery development and production, and has spent the last 20 years working on developing implantable naltrexone technology; and Michael Howcroft, an expert on pharmacology, who is a veteran in drug formulary management. These new members will be instrumental and will provide invaluable insights as we begin our human trials for BICX104. Additionally, the expertise of several of the new members will also be valuable to the growth of the Company’s treatment programs for substance use disorder and weight management.”
A copy of the Company’s quarterly report on Form 10-Q for the second quarter ended June 30, 2021 has been filed with the Securities and Exchange Commission and posted on the Company’s website at https://ir.biocorrx.com/.
About BioCorRx
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; please visit www.uncraverx.com for more information on UnCraveRx™. The Company also conducts R&D under its controlled subsidiary, BioCorRx Pharmaceuticals. For more information on BICX and product 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.
BioCorRx Inc.
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FAQ
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