Innocan Pharma's 2024 Progress in Research and Development

Innocan Pharma's Overview of Research and Development in 2024

Innocan Pharma Corporation, a pharmaceutical technology company with a focus on innovative drug delivery systems, is pleased to share its significant progress in research and development for the upcoming year. This year's activities have demonstrated the potential of its liposome-cannabidiol technology (LPT-CBD) and its applications for both human and veterinary medicine.

LPT-CBD: A Milestone in Drug Development

The year marked impressive achievements in Innocan's development of LPT-CBD. Preclinical studies revealed substantial bioavailability of CBD, resulting in notable pain relief and overall well-being across diverse animal models. Building on these findings, the Company successfully secured the FDA's agreement on the plans for advancing LPT-CBD into Phase 1 clinical trials, which aims to explore its efficacy as a treatment for chronic pain in humans.

Regulatory Advancements

Innocean's accomplishments were further validated when the FDA recognized its innovative technology for use in veterinary medicine. The Center for Veterinary Medicine granted Innocan a fee waiver and assigned an Investigational New Animal Drug (INAD) identification number, which facilitates crucial communications and data exchanges with the regulatory body to expedite the development of its veterinary drug applications.

CEO's Insights on Company Progress

Iris Bincovich, CEO of Innocan Pharma, highlighted the significant regulatory milestones achieved in 2024, stating that the Company exceeded expectations regarding FDA-related goals. With the 505(b)(2) regulatory pathway utilized for LPT-CBD, Innocan is well-positioned to innovate in pain management solutions moving into 2025, enhancing its offerings for both human and animal health.

Details of the Regulatory Pathway

The 505(b)(2) process offers a streamlined avenue for developing LPT-CBD, allowing the use of prior preclinical data from approved products. This pathway is anticipated to reduce development costs and time significantly, ultimately leading to a faster market entry for new therapies.

Latest Developments in Research

In February, Innocan announced promising findings from its pharmacokinetic study in rabbits, reinforcing the prolonged CBD exposure observed in earlier animal trials. The studies revealed that a single LPT-CBD injection could maintain detectable CBD levels for extended periods, establishing its potential for therapeutic application.

Neurological Applications

March saw advancements toward addressing neurological disorders; research indicated that CBD from LPT-CBD reached the brains of test subjects, suggesting that its innovative liposome technology permits significant therapeutic access to the brain, an area often challenging to medicate effectively.

Strategic Approaches Moving Forward

By April, Innocan initiated a vital step in the FDA approval process by submitting a letter of application for a Pre-IND meeting regarding LPT-CBD. This interaction aims to glean insights from the FDA to further refine their clinical development strategy.

Real-World Applications of LPT-CBD

Further demonstrating its commitment to veterinary health, Innocan shared in May the successful treatment of a donkey requiring pain management post-amputation. The immediate results highlighted the lipo-CBD's potential to restore mobility and alleviate discomfort in animal care.

Continuing Regulatory Engagement

In July, the FDA’s feedback from a pre-IND meeting reinforced Innocan's development trajectory by allowing them to present their preclinical findings and clinical plan. This dialogue is crucial as they prepare to enter human clinical trials, aiming for effective chronic pain solutions.

Expert Collaboration

To further bolster its submission process, Innocan engaged Dr. William K. Schmidt. His expertise in pain medicine is vital to navigate regulatory complexities effectively as they seek to progress within the FDA's framework.

Veterinary Innovations and Achievements

Another pivotal moment occurred in July when the CVM recognized Innocan's developments, enabling better support for LPT-CBD's pathway as a new veterinary drug. The waiver granted by the CVM further acknowledges Innocan’s innovative contributions in animal health.

Ongoing Clinical Trials and Future Directions

The milestones continued through September when FDA interactions yielded a positive response regarding Innocan's plans for the LPT-CBD drug. The establishment of a scientific bridge to reference drugs paves the way for expedited approval, crucially aligning both non-clinical and clinical study designs.

Recognition of Scientific Contributions

In October, the Company celebrated Dr. Joseph V. Pergolizzi's recognition among the top 2% of scientists globally, attesting to the depth of knowledge and expertise guiding Innocan's research direction.

Innovative Therapies for Animal Health

The promising evidence from using LPT-CBD in canine osteoarthritis has been particularly noteworthy, showcasing improvements in pain relief and mobility over extended periods. Such findings confirm the therapeutic potential for managing chronic ailments in animals.

About Innocan Pharma

Innocan Pharma stands at the forefront of innovative pharmaceutical and wellness solutions. Its focus on developing a proprietary drug delivery system for CBD provides a strategic edge in non-opioid pain management. Furthermore, Innocan is committed to enhancing the quality of life through a wide range of self-care and beauty products presented under its subsidiary, BI Sky Global Ltd., aimed at fostering healthier lifestyles.

For more information, please contact: Iris Bincovich, CEO, +1-516-210-4025, +972-54-3012842, +44 203 769 9377.

Frequently Asked Questions

What is Innocan Pharma's primary focus in 2024?

Innocan Pharma is focused on advancing its research and development in drug delivery technologies, particularly its liposome-cannabidiol platform for pain management.

What regulatory pathway is Innocan utilizing for LPT-CBD?

The Company is using the FDA's 505(b)(2) regulatory pathway, which facilitates faster drug development by leveraging existing clinical data.

How has LPT-CBD demonstrated efficacy in animals?

Preclinical studies showcased prolonged CBD presence in the bloodstream and demonstrated significant pain relief in various animal models, including a successful case in a donkey.

Who has Innocan partnered with to enhance its development efforts?

The Company has engaged industry experts like Dr. William K. Schmidt to bolster its submission process to the FDA for chronic pain solutions.

What are Innocan Pharma's goals for the future?

Innocan aims to progress its LPT-CBD through human clinical trials and extend its veterinary applications, ultimately improving pain management solutions.

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