GB Sciences is planning to file for and perform a Phase 0 Clinical Trial to gather valuable First-In-Human data on its proprietary cannabis-based therapies for the treatment of early to moderate Parkinson’s disease (PD). The GB Sciences’ Exploratory program is designed to allow the company to make informed, data-driven choices in selecting and prioritizing the development of multiple, related drug compositions and formulations. An Exploratory IND requires less pre-clinical data and offers a more flexible way to get essential information about potential drug development candidates than a more conventional early phase development program. Performing an FDA-Registered clinical trial, instead of a Nevada-based pilot trial as reported earlier, also translates to quicker entry into international markets with harmonized regulatory standards.
As previously reported, GB Sciences has pending US and International patent applications covering multiple, related PD-formulas based on complex mixtures of minor cannabinoids and terpenes from cannabis chemovars. In pre-clinical studies, these complex cannabis-based formulas both increased dopamine production and demonstrated potential neuroprotective properties. The disease processes targeted by GB Sciences’ therapeutic mixtures are central to the progression of PD, as well as other related neurological conditions.
“The Exploratory IND/Phase 0 program allows companies to establish a clinical trial protocol to distinguish between multiple formulations based on various measures, including pharmacological and pharmacodynamic measures that may be predictive of efficacy, as well as measures that will help us assess the mechanism of action of our drug candidates,” explains Dr. Andrea Small-Howard, Chief Science Officer of GB Sciences. “GB Sciences believes that its regulatory strategy can deliver enough data to allow us to select one or more optimal candidates for development and do so more quickly and more efficiently than if we were to proceed directly to a traditional phased development program.”
The company will begin its toxicology studies in the summer of 2018 in preparation for the Exploratory IND, but prior to receiving feedback from the US FDA to verify that the company’s regulatory strategy and Phase 0 clinical trial protocol are acceptable to the agency. GB Sciences expects to commence its First-in-Human Trial in early 2019, pending FDA acceptance of their Exploratory IND application and proposed Phase 0 protocol.
GB Sciences is committed to providing evidence-based therapies to patients in markets beyond those reachable in state-regulated medical marijuana systems. While it may be more difficult to register the First-in-Human trial with the US FDA in the short term, the longer-term benefits for the patients and GB shareholders should be great.
“GB Sciences has always been committed to providing the highest quality therapies to patients, and working through US FDA channels will allow us to get these medicines to patients across the US and internationally quicker than just ‘staying in our lane’ in the less regulated state-run medical cannabis programs,” said John Poss, CEO and Chairman of GB Sciences, Inc. “At GB, we know that doing the right thing may take a little longer, but the rewards are often greater.”