Innocan Pharma Advances Liposomal CBD with FDA's Positive Pre-IND Response

HERZLIYA, Israel and CALGARY, Alberta, Sept. 3, 2024 -- Innocan Pharma Corporation (CSE: INNO) (FSE: IP4) (OTCQB: INNPF) announced a positive outcome from its pre-Investigational New Drug (pre-IND) Type B meeting with the U.S. Food and Drug Administration (FDA) for its leading drug product, Liposomal Technology-CBD (LPT-CBD).

The FDA has accepted the submission of LPT-CBD under the 505(b)(2) New Drug Application (NDA), which establishes a scientific link to a reference listed drug. The 505(b)(2) pathway is known for offering a faster route to patent utilization and commercial approval. This significant development may facilitate a more efficient FDA approval process for LPT-CBD, allowing Innocan to advance its innovative, patent-protected technology.

Innocan has also aligned with the FDA on both the non-clinical development plan and the clinical study design for LPT-CBD's proposed Investigational New Drug (IND) filing for a Phase I clinical study.

Professor Chezy Barenholz, Chief Scientific Officer, expressed satisfaction with the FDA meeting outcomes. He noted that the company now has a clear path to gather the necessary data to initiate clinical studies for treating chronic pain using LPT-CBD.

Dr. Eyal Kalo, Research and Development Director at Innocan, highlighted the company's dedication to addressing chronic pain management. He mentioned that chronic pain affects about 20% of the population, or one in five adults in the U.S., and carries significant unmet medical needs. The positive feedback from the FDA marks a crucial step toward bringing LPT-CBD to market, potentially providing much-needed relief to millions suffering from chronic pain.

Dr. Joseph Pergolizzi, COO at NEMA Research Inc., and a Key Opinion Leader in chronic pain and a member of Innocan's advisory board, emphasized the importance of LPT-CBD in enhancing clinicians' ability to address existing gaps in chronic pain care.

Iris Bincovich, CEO of Innocan, pointed out that LPT-CBD has shown long-lasting CBD release in nonclinical studies. She added that the company's work is vital in the fight against chronic pain, bringing an innovative technological approach to the forefront.

Innocan Pharma Corporation operates in two primary segments: Pharmaceuticals and Consumer Wellness. In the Pharmaceuticals segment, Innocan is focused on developing innovative drug delivery platforms that incorporate cannabinoid science to treat various conditions and improve patients' quality of life. This segment includes the LPT CBD-loaded liposome platform, which facilitates precise dosing and prolonged, controlled release of CBD into the bloodstream. The LPT delivery platform is currently in the preclinical trial phase for chronic pain management.

In the Consumer Wellness segment, Innocan develops and markets a broad range of innovative, high-performance self-care products aimed at promoting a healthier lifestyle. Within this segment, Innocan has established a joint venture known as BI Sky Global Ltd., which focuses on advanced, targeted online sales.

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