Quickly Move Through IND-Enabling Studies

Like all new drugs, a primary challenge in the development of cannabinoid drug products is uncertainty. To ease these risks, generating positive proof-of-concept in animals will greatly reduce the likelihood of failure. In order to quickly transition to first-in-man clinical investigation, a number of IND-enabling studies are required to satisfy FDA requirements to recommend dose and evaluate potential toxicity risks. Depending on how cannabinoids are classified in addition to the intended route of administration and study duration, Santé Laboratories will help you successfully initiate and address your drug development needs with “clinic ready” cannabinoid formulations.

Simplifying the challenging, fast-paced environment to clinic

FDA has limited guidance related to the development of drugs containing cannabis-derived compounds especially as it relates to fully synthetic APIs for use in first-in-man studies. Understanding the pharmacokinetics and safety of cannabinoid formulations, regardless of route of administration, will be an important and necessary undertaking prior to investigational use in humans. Except for cannabidiol (from extract) and synthetic THC derivatives dronabinol and nabilone, cannabinoids will likely be considered new chemical entities (NCEs). The FDA defines NCEs as “drugs that contain no active moiety which has been previously approved by the FDA in any other application”. At this time, the FDA has approved 4 drug products containing synthetic THC (Marinol®, Casemet®, and Syndros®) and plant-based cannabidiol (Epidiolex®). Like NCEs, a number of important IND-enabling studies will be required prior to early-stage clinical work.

Although it’s imperative for drug developers to quickly and successfully move through IND-enabling studies, there is significant commercial incentive to use a formulation technology to solubilize drugs like cannabinoids that is suitable for downstream development and commercialization. With expertise in supporting all stages of early-stage drug development, Santé Laboratories will help you successfully navigate IND-enabling studies through manufacturing and analytical services:

  • Develop highly effective formulations optimized for cannabinoids to address complex solubility challenges to provide adequate systemic exposure for oral administration
  • Manufacture GLP and GMP cannabinoid formulations to support nonclinical investigation such as safety, toxicology, and pharmacokinetics
  • Develop and phase-appropriately validate bioanalytical method for detection of cannabinoids in various matrices and animal models
  • Perform exploratory studies to demonstrate PK parameters as well as biodistribution
  • Identify, qualify, isolate, and assay degradants and impurities to support additional safety studies
  • Perform in vitro metabolic characterization and stability testing
  • Perform in vitro protein binding studies
  • Evaluate biodistribution and tissue sample analysis
  • Dossier preparation for pre-IND meetings, IRB, and IND submissions

Fast-track nonclinical investigation when working with Santé Laboratories.

Features of working with Santé:

  • Relevant expertise and knowledge in cannabinoid sciences to overcome common and uncommon challenges in formulations and analytical sciences
  • Access to formulation technology for various routes of administration that will provide adequate bioavailability to optimize likelihood of study endpoints to be met
  • Rapidly develop, optimize, and manufacture exploratory formulations to support IND-enabling studies
  • Focused to help early-stage companies capitalize on success in positive nonclinical results by providing formulation technology to solubilize cannabinoids and keep them stable over the period of in-life studies
  • In-house capability to quickly develop and qualify analytical methods to assay cannabinoids in investigational formulations to satisfy GLP requirements and stability testing