Full Press Release Details
Its Phase IIb Clinical Trial in Patients with Tourette Syndrome with its Proprietary Drug Candidate SCI-110
The Dual-Site Study Will Be Conducted at the
Hannover Medical School in Germany, and Israel's Tel-Aviv Sourasky Medical Center
TEL AVIV, Israel, January 18, 2022
/PRNewswire/ -- 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.
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.
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.
SCI-110, SciSparc's proprietary drug candidate,
combines dronabinol, an FDA-approved synthetic form of THC (tetrahydrocannabinol), with the endocannabinoid palmitoylethanolamide (PEA).
SCI-110 was designed to increase THC efficacy, thereby increasing the efficiency of oral administration while decreasing dosage requirements,
side effects and adverse events.
Designed to stimulate cannabinoid receptors across
the central nervous system and inhibit the metabolic degradation of endocannabinoids to improve uptake of THC, the potential expected
benefits of SCI-110 are an increase in efficiency of oral administration, and in turn a decrease in dosage requirements, side effects
This product is being developed under the accelerated
regulatory path of 505(b)(2) application focused on augmenting FDA-approved natural and synthetic cannabinoids to create alternate therapies
that potentiate the effects of cannabinoids and target the receptors implicated in modulating the central nervous system.
About SciSparc (NASDAQ:SPRC):
SciSparc Ltd. is a specialty clinical-stage pharmaceutical
company led by an experienced team of senior executives and scientists. Our focus is on creating and enhancing a portfolio of technologies
and assets based on cannabinoid pharmaceuticals. With this focus, the Company is currently engaged in the following drug development programs
based on THC and/or non-psychoactive cannabidiol (CBD): SCI-110 for the treatment of Tourette syndrome, for the treatment of obstructive
sleep apnea and Alzheimer's disease and agitation; SCI-160 for the treatment of pain; and SCI-210 for the treatment of autism spectrum
disorder and epilepsy.
Forward-Looking Statements:
This press release contains forward-looking statements
within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995 and other Federal
securities laws. For example, SciSparc is using forward-looking statements when it discusses the
expected clinical study for SCI-110 and the potential efficacy, safety of SCI-110 for the treatment of Tourette syndrome and the expectation
that SCI-110 may constitute a safe and effective treatment for Tourette syndrome. Historic results of scientific research and
clinical and preclinical trials do not guarantee that the conclusions of future research or trials will suggest identical or even similar
conclusions. Because such statements deal with future events and are based on SciSparc's current expectations, they are subject to various
risks and uncertainties and actual results, performance or achievements of SciSparc could differ materially from those described in or
implied by the statements in this press release. The forward-looking statements contained or implied in this press release are subject
to other risks and uncertainties, including those discussed under the heading "Risk Factors" in SciSparc's Annual Report on
Form 20-F filed with the SEC on March 30, 2021, and in subsequent filings with the U.S. Securities and Exchange Commission. Except
as otherwise required by law, SciSparc disclaims any intention or obligation to update or revise any forward-looking statements, which
speak only as of the date they were made, whether as a result of new information, future events or circumstances or otherwise.