- BICX104 was Well Tolerated with No Serious Adverse Events Reported and Achieved 84 Days of Therapeutic Naltrexone Plasma Concentrations
- BICX104 Subjects Experienced Better 84-Day Treatment Adherence Than Vivitrol® Subjects
- Company Seeking FDA Approval for Immediate Expanded Access “Compassionate Use” of BICX104 for Over 10 Million Americans with Opioid Use Disorder
- BioCorRx Applying for Fast Track Designation and Also Seeking FDA Pre-NDA Meeting to Confirm Final Pathway for Regulatory Approval
Based on the promising results of the Phase I study,
“The opioid overdose epidemic, causing an estimated 80,816 overdose deaths in 2021, almost doubling from roughly 42,000 in 2016i, is such a significant and deepening public health crisis that
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®). Information about the Phase I 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
The Helping to End Addiction Long-term (HEAL) Initiative, or NIH HEAL Initiative, is an aggressive, trans-
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-∞ 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
Poster session details:
Title: “BICX104 Phase 1 Clinical Trial Results: Safe and Effective Naltrexone Implant for Chronic Prevention and Treatment of Opioid Use Relapse”
Abstract Number: 405
Session Information: Date and Time:
Corporate Contact/Clinical Trial Sponsor:
Required Disclaimer: Research reported in this press release was supported by the
About
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.
investors@BioCorRx.com
714-462-4880
Investor Relations:
212- 671-1020 x304bicx@crescendo-ir.com
Source:
i Substance Abuse and Mental Health Services Admin. (SAMHSA). Misuse opioids in US (Total Addressable Market)
ii FDA Website: https://www.fda.gov/news-events/expanded-access/expanded-access-compassionate-use-submission-data.
Source:
2023 GlobeNewswire, Inc., source