Therapix Biosciences has entered into an exclusive agreement with Catalent Pharma Solutions for the formulation, development and clinical manufacturing of THX-TS01, a first-in-class, proprietary investigational drug candidate for the treatment of the symptoms of Tourette Syndrome.
Pursuant to the agreement, Catalent will develop THX-TS01 in softgel form in support of Therapix's clinical development program and in accordance with current good manufacturing practice (cGMP). The formulation, development, analytical and cGMP manufacturing activities will be conducted at Catalent's primary softgel development and manufacturing facility in St. Petersburg, Florida.
"This is the first time that two cannabinoids, Tetrahydrocannabinol and Palmitoylethanolamide, which we believe work synergistically, are being combined in a proprietary single dose that may potentially provide a turnkey solution to addressing the symptoms of Tourette Syndrome,” Ascher Shmulewitz, M.D., Ph.D., Therapix's Chairman of the Board of Directors, said. “Our objective in developing THX-TS01 is to enable the commercialization of a more effective treatment for the symptoms of this devastating, unmet medical need. We believe that this agreement may bring us one step closer to this goal."