Innocan Pharma Corporation has announced significant progress in the development of its liposome-cannabidiol technology (LPT-CBD) for chronic pain management in both humans and animals. The company's 2024 research and development update highlights key achievements, including positive preclinical results and regulatory milestones with the U.S. Food and Drug Administration (FDA).
LPT-CBD Preclinical Success and Regulatory Pathway
Preclinical studies have demonstrated that LPT-CBD exhibits high cannabidiol (CBD) bioavailability and provides long-lasting pain relief in various animal models. These findings have paved the way for discussions with the FDA regarding the advancement of LPT-CBD as a treatment for chronic pain in humans. The FDA has agreed to Innocan's preclinical and Phase 1 clinical development plan, acknowledging the potential of LPT-CBD and its development under the 505(b)(2) regulatory pathway.
The 505(b)(2) pathway is a streamlined approach that leverages existing preclinical data from approved products, potentially reducing development time and costs. This regulatory route is particularly beneficial for innovative formulations like liposomal delivery, allowing for modifications to dosage forms, administration routes, or drug combinations while maintaining stringent safety and efficacy standards.
Iris Bincovich, CEO of Innocan Pharma, stated, "In 2024, we not only met but surpassed our FDA-related goals, achieving regulatory milestones ahead of schedule. With the FDA 505(b)(2) regulatory pathway meeting behind us, these advancements position us to accelerate our development in 2025, bringing us closer to delivering innovative pain management solutions for both human and veterinary applications."
Veterinary Applications and INAD Designation
Innocan's LPT-CBD has also garnered attention from the FDA's Center for Veterinary Medicine (CVM). The CVM granted Innocan a fee waiver for 2024 and issued an Investigational New Animal Drug (INAD) number, facilitating communication and data exchange to support LPT-CBD's development as a new veterinary drug.
Efficacy in Animal Models
Studies in various animal models, including rabbits, mice, dogs, goats, and sheep, have shown that a single subcutaneous injection of LPT-CBD results in prolonged exposure to CBD. Detectable CBD levels were maintained for weeks following a single injection. Furthermore, a tissue distribution study indicated the potential of LPT-CBD to support a new therapeutic venue for neurological disorders, with CBD found in the brains of both mice and rabbits weeks after subcutaneous injection.
In a compassionate case, an amputee female donkey with an inflammatory disease affecting her foot was treated with a liposomal-CBD injection. The donkey regained her ability to walk and move normally following the treatment.
Safety Evaluation
A preliminary safety evaluation of Innocan's single injection and sustained-release LPT-CBD was conducted on minipigs, which are recognized by the FDA as an excellent model for toxicology. The animals exhibited good drug tolerance and did not manifest any drug-related adverse reactions after a single subcutaneous injection of LPT-CBD.
Clinical Support and Expertise
To support its LPT-CBD submission process to the FDA for chronic pain, Innocan engaged Dr. William K. Schmidt, the Past President of the Eastern Pain Association. Dr. Schmidt's expertise in pain-related clinical development and regulatory affairs is expected to contribute significantly to Innocan's team.
Osteoarthritis in Dogs
Promising results were observed in a multi-year compassionate therapy using repeated LPT-CBD injections for pain relief in dogs with naturally occurring osteoarthritis. The therapy consistently demonstrated pain reduction and improved mobility, with effects lasting for several weeks after each injection. In two ongoing cases, dogs suffering from osteoarthritis who had failed to respond to non-steroidal anti-inflammatory drugs (NSAIDs) and oral CBD showed noticeable pain relief, substantially improved mobility, and increased well-being after LPT-CBD treatment.
