CANADA: FSD Pharma has announced the launch of a pilot clinical study in Pittsburgh, Pennsylvania, by its strategic R&D partner, SciCann Therapeutics. The study is designed to test the safety and efficacy of SciCann’s proprietary “Steady Stomach” cannabidiol (CBD) combination product for the treatment of irritable bowel syndrome (IBS) patients. This study follows the previously reported efficacy results from a preclinical study in rodent models which demonstrated a three-fold increased efficacy in lowering abdominal inflammation levels with the advanced combination product as compared to CBD alone.
The double-blind, randomized, placebo-controlled study will enroll 20 patients in a cross-over design to comply with the highest standards of rigorous scientific validity and certification demands of international medical regulatory authorities.
Under the terms of FSD’s strategic agreement with SciCann, the Company holds exclusive manufacturing and distribution rights for the “Steady Stomach” product in Canada.
The study’s principal investigator is Dr. Bryan Doner of Compassionate Care Certifications Centers in Pittsburgh, Pennsylvania and the CRO is Affinity Bio Partners, led by CEO Dr. Christina DiArcangelo Puller.
Dr. Raza Bokhari, CEO of FSD Pharma, stated, “This innovative clinical study aims to demonstrate the safety and efficacy of this easy-to-administer, side-effect-free therapy for a very common disease. Although rarely spoken about, IBS causes suffering to many patients around the world by dramatically reducing quality of life. The launch of this study marks another important milestone for FSD on its way to becoming a leading supplier of superior and differentiated medical, cannabis-based therapies for patients. Together with our partner SciCann, FSD is working tirelessly towards the development of novel and disruptive cannabinoid-based therapies for the world’s most under-treated diseases and irritable bowel syndrome is high on our list of target indications.”
Dr. Zohar Koren, co-founder and CEO of SciCann Therapeutics, stated, “The prevalence of irritable bowel syndrome is estimated at 10-15 percent of the global population. This is an under-diagnosed, hard-to-treat condition that causes an estimated cost to society of over US$21 billion annually in direct medical expenses and indirect costs associated with loss of productivity1. Based on our research, we believe that our proprietary “Steady Stomach” CBD combination product can serve as a new treatment standard to improve the lives of patients. We are looking forward to reporting on the results of this clinical study. ”