Benzinga | Jan 18, 2022 08:14AM EST

SciSparc Advances Its Phase IIb Clinical Trial In Patients With Tourette Syndrome With Its Proprietary Drug Candidate SCI-110

SciSparc Ltd. (NASDAQ:SPRC), a specialty, clinical-stage pharmaceutical company focusing on the development of therapies to treat disorders of the central nervous system (the "Company" or "SciSparc"), today announced that it has entered into an agreement with two clinical sites: Hannover Medical School in Hannover, Germany, and Tel-Aviv Sourasky Medical School, in Tel-Aviv, Israel, to further its Phase IIb clinical study for SCI-110, the Company's proprietary drug candidate, for patients suffering from Tourette syndrome (the "Study" or the "Trial"). The trial will be conducted at the two sites.

The Study's Principal Investigator is Dr. Kirsten M?ller-Vahl, Professor, Managing Senior Physician at the Clinic for Psychiatry, Social Psychiatry and Psychotherapy, and Director of the Tourette Outpatient Clinic at Hannover Medical School.

The Study's Principal Investigator at the Tel-Aviv Sourasky Medical Center is Dr. Tanya Gurevich, Director of the Movement Disorders Unit at the Sourasky Medical Center and Professor at the Sackler School of Medicine, Tel-Aviv University,

Dr. Adi Zuloff-Shani, PhD, Chief Technologies Officer of SciSparc, stated, "We are thrilled and honored to be partnering with both of these distinguished organizations. Dr M?ller-Vahl is a world-renowned authority in cannabinoid-based therapeutics and Tourette syndrome; Dr. Gurevich is a recognized expert in movement disorders and autonomic disturbances, who has researched the impact of cannabinoids on patients with these conditions. Their insight and expertise will be invaluable as we move through this process."

"I am quite optimistic that this Study's findings will support our previous research led by Prof. Michael Bloch, Associate Professor in the Child Study Center at Yale Medical School of Medicine, USA, which showed indications that SCI-110 is potentially a safe and efficacious medication for this highly debilitating disease, and I am hopeful that it will advance our effort to create a viable therapeutic protocol for Tourette syndrome, a condition for which there is currently no effective treatment," Dr. Zuloff-Shani concluded.

Dr. M?ller-Vahl commented on the announcement, "Tourette syndrome is a very complex disorder; most patients suffer not only from tics but also from psychiatric comorbidities including attention deficit/hyperactivity disorder, obsessive-compulsive behavior, depression, and anxiety. Since the endocannabinoid system is implicit within all of these conditions, we believe that it also plays an important role in the pathology of Tourette syndrome. I am hopeful that cannabinoid-based treatments like SCI-110, which modulate the endocannabinoid system will provide effective therapies for patients suffering from Tourette syndrome."

Dr. Gurevich added, "There are a growing number of studies and cumulative clinical experience demonstrating the impact of cannabinioid-based therapies on disorders of the central nervous system, particularly those associated with movement disorders, like Tourette syndrome. I'm impressed with the data I've seen on SciSparc's novel therapy. I share their enthusiasm for the SCI-110 and am excited to join the team navigating it through the review process."

The Trial, which was created in compliance with the valid version of the Declaration of Helsinki and GCP guidelines, will be a randomized, double-blind, placebo-controlled, cross-over study to evaluate the efficacy, safety and tolerability of daily oral SCI-110 as compared to placebo, in treating adults age 18 to 65, with Tourette syndrome. Patients will be evaluated in a cross-over design, with each subject randomized to receive either SCI-110 or placebo via oral administration.

Tourette syndrome is a neurological disorder characterized by involuntary movements and vocalizations called tics and is estimated to affect approximately 1% of the world's population. Currently, there is no cure for Tourette syndrome, and conventional therapy focuses on behavioral therapy combined with psychotropic drugs, most of which yield unsatisfactory results and come with serious side effects including sedation, weight gain, and sexual dysfunction.