FDA Schedules Meeting with Innocan Pharma for LPT-CBD in Chronic Pain Treatment

Innocan Pharma Corporation, based in Herzliya, Israel, and Calgary, AB, has announced substantial progress in the regulatory process for its innovative Liposome-Cannabidiol (LPT-CBD) technology. This technology is aimed at providing an alternative to opioid-based pain management. The U.S. Food and Drug Administration (FDA) has assigned an Investigational New Drug (IND) number to Innocan and approved an initial meeting to discuss the development path forward.

The FDA meeting is scheduled for July 31, 2024, during which Innocan will present its preclinical results and outline its proposed clinical development plan. This meeting is a critical milestone for the commencement of human clinical trials for the LPT-CBD injectable drug, designed to offer a novel treatment option for chronic pain.

Innocan Pharma's CEO, Iris Bincovich, expressed enthusiasm about this significant step towards launching the IND program for LPT-CBD in the United States. She emphasized that the upcoming FDA consultation is pivotal and will likely set the stage for the company's clinical trials, advancing their mission to revolutionize pain management. Bincovich also acknowledged the contributions of Prof. Chezy Barenholz and Dr. Ahuva Cern of the Hebrew University of Jerusalem, whose expertise in liposome research has provided strong supportive data for LPT-CBD, facilitating the upcoming engagement with the FDA.

LPT therapy requires only a single monthly subcutaneous injection, presenting a groundbreaking alternative to opioid-based treatments. This is particularly important given the opioid crisis in the United States, where, according to the U.S. Centers for Disease Control and Prevention, over 75% of drug overdose deaths involve opioids. In various pre-clinical trials, Innocan's LPT-CBD injectable treatment has consistently demonstrated efficacy through prolonged and controlled release of CBD in animals with chronic pain conditions.

Innocan Pharma operates under two main segments: Pharmaceuticals and Consumer Wellness. In the Pharmaceuticals segment, the company focuses on developing innovative drug delivery platform technologies based on advanced cannabinoid science to treat various conditions and improve patients' quality of life. This includes two drug delivery technologies: the LPT CBD-loaded liposome platform, which allows for precise dosing and the prolonged and controlled release of CBD into the bloodstream. This technology is currently in the preclinical trial phase for pain management.

In the Consumer Wellness segment, Innocan develops and markets a wide range of innovative and high-performance self-care products to promote a healthier lifestyle. As part of this segment, Innocan has established a joint venture named BI Sky Global Ltd., which focuses on advanced targeted online sales.

In summary, Innocan Pharma Corporation has made notable strides in advancing its LPT-CBD technology through the regulatory approval process with the FDA. The upcoming meeting in July 2024 is expected to be a crucial step towards initiating human clinical trials, with the potential to provide a groundbreaking, non-opioid treatment option for chronic pain. This development aligns with Innocan's broader mission to revolutionize pain management and improve patients' quality of life through innovative drug delivery technologies.