Government Regulation and FDA Regulatory Pathway
The Food and Drug Administration (FDA) oversees the rigorous process of approving new drugs and treatments in the United States, ensuring they meet stringent safety, efficacy, and quality standards before reaching the market. This regulatory pathway is vital for protecting public health and maintaining trust in the pharmaceutical and wellness industries. As we continue developing Liposome-based products for both human and veterinary use, we are committed to aligning with the FDA’s comprehensive requirements and strict process.
Our company is adopting a dual-track approach to FDA submissions, pursuing approval for human and veterinary applications. This strategy underscores our commitment to expanding the benefits of our LPT-based innovations to addressing chronic pain conditions, ensuring that both humans and animals can access safe and effective treatments.
Veterinary Application of Liposome-based Technology
Our LPT technology is designed as a veterinary drug aimed at treating companion animals experiencing chronic pain. A clinical pilot study utilizing cannabidiol-loaded LPT on companion dogs with osteoarthritis demonstrated significant pain relief. In connection with these results, we are conducting feasibility studies on pharmacokinetics and safety in healthy dogs, laying the groundwork for a pre-development meeting with the FDA’s Center for Veterinary Medicine (CVM).
Upon completion of these studies, we will compile a submission package that encompasses our clinical efficacy results alongside preliminary pharmacokinetic and safety data. Our goal is then to file an Investigational New Animal Drug (INAD) application and engage in a pre-development meeting with CVM to outline our development strategy for dogs.
Human Application of Liposome-based Technology
We have commenced the regulatory review process with the FDA, starting with a pre-IND meeting scheduled at the end of July 2024 to present our pre-clinical findings, and our established plans for IND-enabling studies as well as Phase 1 clinical studies.
Our comprehensive pre-IND package details extensive experiments demonstrating the efficacy, long-lasting pharmacokinetics, and basic safety of cannabidiol-loaded LPT when used for up to 9 months in small as well as big animals such as mouse, dogs and goats.
During the pre-IND meeting we intend to discuss with FDA about our data and ask whether our provided efficacy and PK results in various animals is sufficient to initiate an IND. During our discussion we also plan to ask if the FDA concurs with our suggested toxicological studies in rabbits and other invitro models to assess the safety of repeated LPT-CBD subcutaneous administration for 9 months. Finally, we plan to discuss with the FDA about our designed phase 1 clinical studies to be conducted when an IND will be enabled by the FDA.
In parallel we will conduct a full CMC development for LPT-CBD including design by quality to determine drug specifications, production scale-up under GMP to allow the execution of both toxicology and phase 1 clinical studies, finalizing the development of analytics methods and qualifying them for batch release, controlled stability studies and final liposomal CBD drug characterization as required by FDA’s liposomal drug development guidance. We intend to prepare and submit a CMC package to the FDA.
Regulatory Pathway
A detailed graphic below outlines the process and current status of our regulatory pathway:
In addition to our pharmaceutical endeavors, we are equally dedicated to adhering to the regulatory requirements for wellness products. While the oversight for these products differs from pharmaceuticals, our commitment to quality, safety, and compliance remains unwavering. We rigorously test and validate the efficacy of our wellness offerings, ensuring they meet the high standards consumers expect and deserve.
By navigating these regulatory paths with diligence and precision, we are poised to make significant contributions to health and wellness, demonstrating our unwavering commitment to innovation, safety, and regulatory excellence.
