BioCorRx Inc. has announced interim positive safety and pharmacokinetic (PK) results for the Phase I clinical trial of the Company's BICX104 implantable naltrexone pellet. Dr. Andrew P. Mallon, PhD, the principal investigator of BioCorRx's Phase I study, funded by the National Institute on Drug Abuse (NIDA) through the Helping to End Addiction Long-term Initiative, or NIH HEAL Initiative, presented the interim findings on February 21, 2023, at the 4th Annual HEAL Investigator Meeting. Based on the promising results of the Phase I study, BioCorRx expects to seek approval from the FDA to provide BICX104 under an expanded access treatment protocol through existing specialist centers that have experience in providing extemporaneously compounded naltrexone implantable products, as well as those experienced in treating their patients with other forms of naltrexone after detoxification.

An expanded access treatment protocol is a pathway for patients with serious or immediately life-threatening conditions to gain access to an investigational medical product (drug, biologic, or medical device) that has not yet received full FDA approval but can be used for treatment outside of clinical trials when no comparable or satisfactory alternative therapy options are available. BioCorRx is compiling the data and drafting its Pre-NDA Briefing Book and final NDA-enabling steps in anticipation of a pre-NDA meeting with the FDA. Additionally, the Company would separately apply for Fast Track Designation for BICX104 to expedite the approval process at the FDA.

BICX104 clinical study is a Phase I, 6-month, open-label, multi-center study in parallel groups of randomized healthy volunteers to evaluate the pharmacokinetics and safety of BICX104 implantable subcutaneous naltrexone pellets and Vivitrol® intramuscular depot naltrexone injection. Twenty-four male and female healthy volunteer subjects were randomized in a 1:1 ratio of both gender and study treatment arm: 12 subjects were administered BICX104 (3-month naltrexone pellets) and 12 subjects were to receive three consecutive 1-monthly naltrexone IM (intramuscular) injections (Vivitrol®). BICX104 is being developed through a Cooperative Agreement with the NIDA, part of the NIH, under award number 3UH3DA047925-03S, funded by the Helping to End Addiction Long-term (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). Interim Data Highlights: The Vivitrol study arm witnessed pronounced study non-compliance with six subjects voluntarily discontinuing treatment: four subjects after one Vivitrol injection; one subject after two Vivitrol injections and one subject after three Vivitrol injections. A seventh subject was terminated due to a positive drug urine screen.

Five subjects completed the study An interim assessment of the Proportion of Days Covered (PDC) by all study subjects except one that was involuntarily terminated observed that there were more highly adherent (>80%) to BICX104 (91.6%; n=12) than Vivitrol (54.5%; n=11). Subcutaneous implantation of BICX104 pellets was achieved using a simple, 15 minute, out-patient procedure undertaken by a physician, Board Certified in Internal Medicine, specialized in addiction treatment and with background in urgent care; Study comprised of an initial 84-day treatment period with follow-up period over days 85 to 168. Study completes on March 22nd, 2023; Eight subjects completed BICX104 and provided sufficient evaluable subjects for this interim PK and safety assessment: BICX104 was generally well-tolerated with no serious adverse events; Only mild adverse events were reported and these were largely limited to local reactions related to the implantation or procedure: itching (3), redness (7), swelling (2), pain (1), and tenderness (1).

Two subjects reported loss of appetite and one of them also reported a loss of taste that was not unexpected due to reduction in cravings that naltrexone can elicit. One report of mild shortness of breath; All AEs were transient and resolved: BICX104 Interim PK data (mean ± standard deviation) reported naltrexone Cmax 19.91 ± 7.09 ng/ml at a consistent Tmax 12 hours. AUC0-8 799.3 ± 110.18 day ng/ml; Steady state naltrexone concentrations (Cday ± SD) included C28: 11.32 ± 2.42 ng/ml (n=7); C56: 6.85 ± 1.33 ng/ml (n=8); C84: 1.69 ± 1.13 ng/ml (n=7); C91: 0.82 ± 0.91 ng/ml (n=8); The last observed day of naltrexone concentrations above the Opioid Use Disorder and Alcohol Use Disorder therapeutic level of 1 ng/ml was Day 84.