SCI-110, our proprietary drug candidate, containing Dronabinol (-FDA approved synthetic form of THC), with the endocannabinoid palmitoylethanolamide (PEA). Designed to stimulate cannabinoid receptors across the Central Nervous System and inhibit the metabolic degradation of endocannabinoids in order to improve uptake of THC, the expected benefits of SCI-110 are an increase in efficiency of oral administration, and in turn a decrease in dosage requirements, side effects and adverse events. 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.
This approach qualifies us for access to the FDA’s 505 (b)(2) regulatory strategy, created to facilitate the submission of novel drug candidates that meet specific criteria to the FDA for review. The 505 (b)(2) application provides us with several advantages as compared to a typical New Drug Application, including potential; lower risk and development costs, and a potentially expedited time to market.
SCI-110 is currently in the clinical trial development stage for the treatment of the following indicators: Tourette Syndrome- (TS) Obstructive Sleep Apnea- (OSA) Alzheimer’s Disease and Agitation.
CannAmide™ is an immediate unique palmitoylethanolamide (PEA) oral formulation for the reduction of chronic pain and inflammation. PEA is a cannabinoid mimetic lipid molecule found throughout the body, including the central nervous system. Similar to cannabinoids, PEA has been shown to have neuroprotective, anti-inflammatory, analgesic and anti-convulsant properties.
CannAmide is currently available in tablet form, with each dose containing 400mg active pharmaceutical ingredient. It has been designated a product license issuance from the Natural and Non-prescription Health Products Directorate (NNHPD) from Health Canada, for sale as a supplement within the nutraceuticals market.
Our proprietary drug candidate containing cannabidiol (CBD), a non-psychoactive cannabinoid, and PEA.
This product is initially being developed under the regulation of the Israeli Medical Cannabis Agency (IMCA) – the agency that leads the regularization of the medical cannabis field in Israel and is the first of its kind in the world. It is a complex, unique, innovative and original process. Conducting clinical trials and development under the regulation of the HQR ostensibly enables rapid and specific registration processes in a track that is unique to Israel.
The company intends to further develop the product for markets outside Israel as well.
Indications currently being investigated for treatment with SCI-210 include
Autism Spectrum Disorder (in clinical trials)
Status Epilepticus – a form of seizures that are severe and sometimes fatal. This indication is currently investigated in pre-clinical settings.
SCI-160 is an innovative, proprietary synthetic CB2 receptor agonist created, among others, for the treatment of pain and is currently in pre-clinical studies. The CB2 receptor agonist used in this formulation – HU-433 – was invented and synthesized by Professor Raphael Mechoulam, Ph.D., Chairman of the SciSparc Scientific Advisory Board, and is protected under a patent granted in the U.S. and Europe.
Our research and development efforts are focused on creating a proprietary and unique combination of products available already in the market (CannAmide™), products in the accelerated regulatory path of 505 (b)(2) application (SCI-110, SCI-210) and products that constitute a new chemical entity (SCI-160) in order to bring different products to market at different timelines and potentially enable us to generate immediate revenues for the company. augmenting FDA-approved natural and synthetic cannabinoids in combination with our proprietary compounds and technologies to create alternate therapies that potentiate the effects of cannabinoids and target the receptors implicated in modulating the central nervous system.
SciSparc has built an intellectual property portfolio which currently comprises three granted U.S. patents and pending patent applications in six families, all focused on disorders of the central nervous system. Currently, our drug candidates are designed to treat Tourette Syndrome, Autism Spectrum Disorder, Epilepsy, Obstructive Sleep Apnea, Alzheimer’s Disease and Agitation, and Chronic Pain.