With an Estimated $16.3 Million Market Cap, This Specialty Pharmaceutical Company is Jumping on the pharmaceutical Cannabinoid Opportunity and is Quickly Rising to the Top of its Industry Sector!

The company’s 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.

Indications currently being investigated for treatment with SCI-110 include:

– Tourette Syndrome- (TS)
– Obstructive Sleep Apnea (OSA)
– Alzheimer’s Disease and Agitation

SCI-110 for TOURETTE SYNDROME (TS) PHASE IIA Led by Yale University 

TS is a movement and neurobehavioral disorder characterized by motor and vocal tics and is highly linked with co-morbidities. 

As the currently used medications are managing only a small number of disease symptoms with limited efficacy and questionable safety, there is a clear unmet medical need for the management of TS 

Results from their Phase IIA clinical trial conducted in Yale University: 

An average tic reduction of 21% across the entire sample with almost 40% of the patients experiencing greater than 25% in tic reduction as defined by YGTSS-TTS (a clinician-rated instrument considered as the gold standard for assessing tics in patients with Tourette's Syndrome) 

The medication was generally well-tolerated by subjects
12/16 subjects elected to continue into a 24-week extension phase of the trial.

SCI-110 for TS PHASE IIB 

• Objective: to evaluate the efficacy, safety and tolerability of the Company’s proprietary SCI-110 in a randomized, double-blind, placebo controlled, cross- over study 
• Two medical centers: Hannover Medical School, Hannover, Germany and Tel- Aviv Sourasky Medical Center, Tel-Aviv, Israel 
• 1:1 ratio randomization to receive either SCI-110 or SCI-110 matched placebo (i.e., THC active, CannAmideTM placebo) 
• Design: 12 weeks treatment, washout period of 2 weeks, crossover for another 12 weeks 
• Primary efficacy: change in YGTSS-R-TTS1 as a continuous endpoint at week 12 and week 26 of the double-blind phase compared to baseline 
• Primary safety: absolute and relative frequencies of Serious Adverse Events (SAEs) for the whole population and separately for SCI-110 and placebo groups 

SCI-110 for ALZHEIMER’S DISEASE (AD) & AGITATION Phase IIA 

AD or mixed dementia (AD + Vascular Dementia) accounts for over 2/3 of all dementia(s)* with majority of AD patients' manifest agitation and anxiety. 

Objective: to evaluate the safety, tolerability and efficacy trend of SCI-110 in an open label study in patients with Alzheimer Disease (AD) and Agitation Clinical site: Sophie & Abraham Stuchynski Israeli Alzheimer's Medical Center Israel 

20 patients will be treated with SCI-110 in a daily dose of up to 12.5mg THC+800 mg PEA
Primary end point: safety and tolerability of SCI -110 in AD patients with agitation 

Main efficacy trend: The ability SCI -110 to ameliorate agitation in patients with AD as measured by the Cohen Mansfield Agitation Inventory (CMAI).

SPRC’s 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-210 FOR AUTISM SPECTRUM DISORDER (ASD) Phase III* 

ASD is a condition related to brain development that impacts how a person perceives and socializes with others, causing problems in social interaction and communication. 

Study objective: to evaluate the safety, tolerability and efficacy of SCI-210 in children with ASD in a randomized, double- blind, placebo controlled with cross-over study.

Study design: A 20-week, randomized double-blind placebo-controlled with cross-over clinical trial of 60 children, 30 participants for SCI-210, or SCI-210 placebo (CBD active, CannAmideTM placebo) for 20 weeks, Washout for 2 weeks, Crossed over for additional 20 weeks 

Three primary efficacy end points: The Aberrant Behavior Checklist-Community (ABC-C) parent questionnaire; The Clinical Global Impressions-Improvement (CGI-I) performed by a clinician. 

SCI-210 for STATUS EPILEPTICUS (SE) 

Status Epilepticus is a seizure that lasts longer than 5 minutes or one in which a person has more than 1 seizure within a 5-minute period, without returning to a normal level of consciousness between episodes.

There is limited pharmaceutical treatment available for treating epilepsy, as about one in three patients have drug- resistance against epilepsy!

In June 2018, the FDA approved purified plant-derived CBD (Epidiolex) for the treatment of seizures associated with Lennox-Gastaut and Dravet syndromes in patients aged two years and older. But CBD monotherapy has several adverse effects, the most common being lethargy, elevated liver enzymes, decreased appetite, diarrhea, poor sleep quality and infections.

In addition, CBD therapy requires a constant increase in therapeutic doses to stay effective and leads to the development of tolerance. 

The Company intends to utilize its proprietary SCI-210 platform, combining PEA with CBD treatment to achieve maximum effect with minimal adverse side effects in Epilepsy patients. PEA Significantly Increases CBD Effects**: CBD was shown to prevent fat accumulation in liver cells in a concentration dependent manner .PEA by itself didn’t affect fat accumulation. Addition of PEA to CBD reduced the required CBD concentration while achieving maximal effect.

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.

SCI-160 FOR PAIN 

An innovative and proprietary CB2 Receptor (CB2R) agonist formulation intended for the treatment of pain. This specific CB2R agonist was synthesized by Professor Raphael Mechoulam, Ph.D. 

CB2 Receptor specific agonists have been found to be involved in mediating analgesic effects in the peripheral nervous system, without significant side effects.

After successful completion of pre-clinical studies, the Company will file an FDA Investigational New Drug (IND) Phase I study application.

SCI-160
PRE-CLINICAL RESULTS 

In a Von Frey Test, rats were evaluated for tactile allodynia using a Von Frey Filament. Promising results demonstrate analgesic 40 efficacy is better than morphine.

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.

The legalization of cannabis in recent years, as well and the rise in awareness among consumers regarding health benefits of cannabis and its growing medical application such as treatment of wide range of diseases and symptoms, including:

Cancer, chronic pain, depression, arthritis, diabetes, glaucoma, migraines, epilepsy, multiple sclerosis, acquired immunodeficiency syndrome (AIDS), amyotrophic lateral sclerosis (ALS), Alzheimer’s, post-traumatic stress disorder (PTSD), Parkinson’s, and Tourette’s have been driving the market for medical cannabis to impressive growth!

This is a multi-billion dollar market! The global cannabis pharmaceuticals market size is expected to reach USD 127.1 billion by 2028! The market is expected to expand at a CAGR of 104.2% from 2022 to 2028.

Furthermore, the global cannabis market size is projected to reach $176 Billion by 2030 with the legalization for medicinal purposes leading this growth