Advances for Tourette Syndrome, Alzheimer's Disease, Pain Management, Autism Spectrum Disorder

Information may not be reliable

Ø  Cannabinoid Pharmaceuticals Development Addressing CNS Disorders.

Ø  Products Aimed at Treatment of Tourette Syndrome, Alzheimer's Disease, Pain Management, Autism Spectrum Disorder and Epilepsy.

Ø  Publication of Manuscript on Tourette Study Conducted at Yale University.

Ø  Patents from Australia & Japan for Novel Compounds and Methods.

Ø  Positive Topline Results for Proprietary Pain Management Compound in Pre-Clinical Study Indicating Significant Analgesic Effect.

Breaking News:

Patent Extends Protection for its Novel Compounds and Methods Already granted in Australia and Japan

TEL AVIV, Israel, Jan. 4, 2022, 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"), marks today one of the Company's most important milestones to date - the U.S. Patent and Trademark Office has granted it a new patent - U.S. Patent No. 11,207,290, titled combinations of cannabinoids and n-acylethanolamines (the "Patent"). The invention relates to "Pharmaceutical compositions comprising cannabinoids and N-acylethanolamines, and methods for their use in preventing and treating a variety of cannabinoid-treatable conditions."

SciSparc Ltd. Logo (PRNewsfoto/SciSparc Ltd.)

"As an innovative pharmaceutical company, our IP portfolio is one of our greatest and most important assets. Obtaining a U.S. patent for our core technology constitutes a major achievement for us, especially as we are one of the few companies in the field that has IP protection on compounds and not only indications. We are pleased that the U.S. Patent and Trademark Office has again recognized the uniqueness of our compounds and methodologies and granted this patent," said Adi Zuloff-Shani, PhD, Chief Technologies Officer of SciSparc.

This patent further strengthens the Company's intellectual property portfolio and protection of its core technologies, and in one of the most important markets in the world.

This is SciSparc's fourth granted patent in the U.S. Recently, the Company announced it has been granted the same patent in Australia and Japan.

Dr. Zuloff-Shani added, "Our growing portfolio of patents is a testament to the dedication and innovation of the SciSparc team and strengthens our commitment to continue the work we do to bring therapies to patients suffering with the challenges associated with disorders of the central nervous system, for whom there is currently no effective treatment."

ABOUT SPRC:

SciSparc Ltd. (NASDAQ: SPRC) is a specialty clinical-stage pharmaceutical company led by an experienced team of senior executives and scientists. The SPRC focus is on creating and enhancing a portfolio of technologies and assets based on cannabinoid pharmaceuticals. SPRC proprietary compounds capitalize on the biochemistry of receptors that specialize in modulating the central nervous system to create therapeutics that mitigate the adverse symptoms associated with CNS disorders.

SPRC 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.

Ø  SPRC Ordinary Shares Commence Trading on Nasdaq Capital Market

On December 22^nd SPRC announced that its ordinary shares began trading on The Nasdaq Capital Market ("Nasdaq").

"Uplisting our shares to Nasdaq is a great way to end the year!" said Amitai Weiss, Chief Executive Officer of SPRC. "We have been working diligently toward this milestone since announcing our rebranding earlier this year. It reflects the improvements we have made to the fundamental value of the Company, including a growing patent portfolio, advancements in our clinical studies and notable additions to our leadership team."

"Trading on Nasdaq should increase our visibility in the market, as well as provide broader access to individual and institutional investors going forward. I am confident that all of these developments will enhance our ability to develop the therapeutics that will improve the lives of those suffering from central nervous system disorders," concluded Mr. Weiss.

Ø  SPRC Announces the Publication of a Manuscript Describing Tourette Syndrome Study Conducted at Yale University

The manuscript titled "A Pilot Study of a Therapeutic Combination of Δ9-tetrahydracannabinol and Palmitoylethanolamide for Adults with Tourette Syndrome," was published in The Journal of Neuropsychiatry and Clinical Neurosciences

On October 18^th SPRC announced the publication of a manuscript that teaches the uses of its proprietary drug candidate SCI-110 for Tourette Syndrome (TS). The study was conducted at the Department of Psychiatry, and the Child Study Center at Yale University in New Haven, Connecticut, USA.

The SPRC paper describes the phase IIa clinical trial conducted at the Child Study Center at Yale University, aimed to evaluate the efficacy of SCI-110 on tic severity as manifested in the improvement in Yale Global Tic Severity Scale (YGTSS) total tic score Index. Secondary outcomes included measures of comorbid conditions and the number of subjects who elected to continue treatment in the 24-week extension phase. Results of the study, described in the paper showed a significant improvement over time of tic symptoms with SCI-110 treatment (General Linear Model time factor: F=3.06, p=0.006).  Improvement in tic symptoms compared to baseline was statistically significant within 1 week of starting treatment.  SCI-110 treatment led to an average improvement in tic symptoms of over 20%, or a 7-point decrease in YGTSS score.  Twelve of 16 subjects elected to continue into the extension phase and only two subjects dropped out early.  Side effects were common although none were serious. Moreover, they were generally managed by decreasing D9-SCI dosing, slowing the dosing titration and shifting dosing to nighttime.

The SPRC SCI-110 platform is based on two active components: (1) tetrahydrocannabinol (THC) which is the main cannabinoid molecule in the cannabis plant, and (2) palmitoylethanolamide (PEA), which is an endogenous fatty acid amide that belongs to the class of nuclear factor agonists, which are proteins that regulate the expression of genes. The combination of THC and PEA induce a "sparing effect" reaction." Thus, it is proposed that the presence of the PEA molecule increases the efficacy of THC, while reducing the required dosage and decreasing associated deleterious adverse events.

"We are very pleased with the acceptance of this paper by a distinguished peer reviewed journal like the Journal of Neuropsychiatry and Clinical Neurosciences.  This is an additional recognition of the therapeutic potential of SCI-110 in Tourette Syndrome. We are also honored by the fruitful collaboration with Yale University which we see as an example of beneficial partnership between industry and academia, an important means in the development of treatments aiming to relieve patients' symptoms, especially in diseases where current treatment is poor, ineffective and accompanied by multiple side effects," said Dr. Adi Zuloff-Shani, Chief Technologies Officer of SciSparc. "As stated in the past, based on these study results, we are initiating a randomized, double-blind, placebo controlled study to evaluate the safety, tolerability and efficacy of daily oral SCI-110 in treating adults with Tourette Syndrome".

Ø  SPRC Awarded Three Patents for Novel Compounds and Methods

On September 7^th SPRC announced it has been awarded two patents from the Australian Patent Office and one from the Japanese Patent Office concerning the proprietary compounds and methods underlying the Company's core technologies (the "Patents"), as listed below:

Australian Patent #AU2016254685A1 and Japanese Patent #2018-507796

Pharmaceutical compositions comprising cannabinoids and N-acylethanolamines, and methods for their use in preventing and treating a variety of cannabinoid-treatable conditions.

Australian Patent #AU2016263292A1

Pharmaceutical compositions comprising opioids and N-acylethanolamines, and methods for their use in preventing and treating a variety of opioid- responsive conditions and opioid-related side-effects.

Adi Zuloff-Shani, PhD, Chief Technologies Officer of SPRC, commented on the announcement, "I am pleased that the Australian and Japanese patent offices have recognized the uniqueness of our pharmaceutical compounds. This is important for the long-term value of any associated products as the Patents establish claims that safeguard the core technologies at the heart of our product pipeline."

"The approvals strengthen the value of our IP portfolio and build on our competitive advantage in the emerging psycho-pharma market. We filed the International PCT applications to facilitate our ability to participate in the global market. Australia and Japan are the first countries to grant the Patents and I expect Europe, Israel, Canada and China to follow," Zuloff-Shani concluded.

Ø  Positive Topline Results for Proprietary Pain Management Compound in Pre-Clinical Study; Study Indicates Significant Analgesic Effect on Acute and Chronic Pain

On August 2^nd SPRC announced positive top-line results for its proprietary compound, SCI-160 in a controlled pre-clinical trial on neuropathic and post-operative pain.

The study, "An evaluation of SCI-160 on neuropathic pain in the rat spared nerve injury (SNI) model and post-surgical pain in the rat hind paw incision model," was designed to help assess the potential of SCI-160, the SPRC proprietary compound.

Key findings from the pre-clinical trial are as follows:

• SCI-160 significantly alleviates pain up to 6 hours after injection as compared with vehicle-treated animals
• Daily SCI-160 injections significantly alleviate subject pain from mechanical stimuli as compared with vehicle-treated animals, for up to 7 days after surgery
• Daily injections of SCI-160 significantly alleviate pain in a hind paw incision model of post-surgical pain up to 4 days post surgery as compared with vehicle treated animals
• SCI-160 analgesic effects are prolonged in the presence of palmitoylethanolamide (PEA)

Collectively, the results indicate that treatment with SCI-160 significantly alleviates both chronic and acute pain.

A study conducted by The G4 Alliance reports 300 million surgical procedures are performed annually, with an estimated 60 to 70% of patients experiencing moderate to severe pain just after 24 hours of surgery. The global postoperative pain management market is expected to account for $45 billion by 2026.

Zuloff-Shani went on to say, "Opioids generate nearly $20 billion in revenue each year, and while they are an effective means for the treatment of pain in some cases, it is troubling that they are often considered the first, if not only option, despite epidemic levels of addiction, abuse and overdose. SPRC remains committed to creating a fast onset, non-addictive, long lasting treatment that can reduce the need for opioids for patients managing neuropathic pain following surgery, and I believe we are well on our way."         

The SPRC SCI-160 is a proprietary preparation comprised of HU-433, the patented synthetic CB2 receptor agonist synthesized by Professor Raphael Mechoulam, Ph.D., Professor of Medicinal Chemistry at the Hebrew University, head of the Medicinal Chemistry Lab and President of Multidisciplinary Center for Cannabinoid Research, recipient of the Israel Prize in Exact Sciences - Chemistry and EMET Prize in Exact Sciences – Chemistry, as well as Chairman of SciSparc Scientific Advisory Board.

For more information on SciSparc Ltd. (NASDAQ: SPRC) visit: https://www.scisparc.com  

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