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Schedule 1 Therapeutics, Inc.


222 Merchandise Mart Plz Ste 1230
Chicago, IL, 60654-4342

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Number of Employees: 1

HUBZone Owned: No

Woman Owned: No

Socially and Economically Disadvantaged: No

SBIR/STTR Involvement

Year of first award: 2020


Phase I Awards


Phase II Awards


Conversion Rate


Phase I Dollars


Phase II Dollars


Total Awarded


Up to 10 of the most recent awards are being displayed. To view all of this company's awards, visit the Award Data search page.

Seal of the Agency: HHS

Optimization of Cannabinoids for Development as FDA-Approved Migraine Therapeutics

Amount: $308,465   Topic: NIDA

Optimization of Cannabinoids for Development as FDA-Approved Migraine Therapeutics Project Summary: Migraine is a disorder that affects 15% of all people in the US, the majority of which are women. Migraine is one of the leading causes of missed days at work during which patients are unable to complete many daily activities. Currently approved treatments for migraine are not satisfying with at most half of the patients relieved from their pain. There is historical evidence for the efficacy of cannabis for the treatment of migraine. However, due partly to the regulatory status of cannabis in most countries worldwide, there are very few clinical or pre-clinical studies on its efficacy on migraine symptoms. The limited studies that do exist suffer from lack of controls or lack of knowledge of which of the many cannabinoids are present in the tested preparations and which of those cannabinoids are responsible for efficacy. Overall, there is a critical need for more rigorous preclinical and clinical studies of the effect of cannabis on migraine headache to better characterize the efficacy and adverse effects of its multiple components. The specific molecules extracted from cannabis that will be used in this study are ?9-tetrahydrocannabinol (THC) and cannabidiol (CBD), the two primary plant- based cannabinoids. These molecules have different pharmacological and physiological effects and also have distinct adverse effect profiles. In an effort to provide proper preclinical scientific rationale for a formulation of cannabis-derived molecules that can be developed into an FDA-approved treatment of migraine, Schedule 1 Therapeutics is developing purified, orally administered CBD and THC molecules and proposes to test them as acute treatments for migraine. The objective of the proposed project is to determine the efficacy of purified CBD and THC in a preclinical model of migraine and identify a ratio of CBD:THC that maximizes efficacy and minimizes adverse effects. Our overall hypothesis is that while CBD and THC may show efficacy when used separately, a combination of the two will be more effective with fewer adverse effects than either alone. We propose two aims that use well established experimental behavioral approaches to validate CBD and THC as good candidate drugs to be further developed for the treatment of migraine symptoms. In Aim 1, we will determine the most efficient combination of CBD:THC to reduce CGRP-induced migraine-like phenotypes in mice. In Aim 2, we will determine the adverse effects of the different combinations of CBD:THC in mice. We propose to study THC and CBD separately as well as together in different combinations in order to find an optimal ratio that would have a high efficacy and low adverse effects. The outcome of these studies will add much-needed data from rigorous experiments to the scientific literature on the efficacy of cannabinoids for migraine and also constitute components of the development plan of cannabis-based drug by Schedule 1 Therapeutics. The optimal CBD:THC ratio determined by these studies will then serve as a lead product formulation for further development by Schedule 1 Therapeutics.PROJECT NARRATIVE - RELEVANCE TO PUBLIC HEALTH Migraine represents a significant burden to society. The proposed experiments will establish whether a cannabis extract of cannabidiol and ?9-tetrahydrocannabinol, alone or in predefined combinations designed to optimize efficacy and minimize adverse effects, could be developed into valid FDA- approved therapeutics to treat migraine. FDA-approved cannabis-based drugs for migraine would provide an excellent alternative for the part of the patient population that doesn’t respond to existing treatments, as well as an alternative to the use of unregulated or illicit cannabis.

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Phase I