Palm Beach, FL – June 7, 2022 – FinancialNewsMedia.com News Commentary – The global Central Nervous System (CNS) treatments and its market revenues had been steadily growing pre-pandemic and are still projected to continue to grow over the next years to come. Several factors that have contributed to the growth of the developed market in recent years including the increased Demand for Multiple Sclerosis drugs have helped to proliferate market growth. A report from Fortune Business Insight discussed the market and said that: “Based on disease segment type, the global CNS therapeutics market is classified as neurovascular diseases, neurodegenerative diseases, mental health, infectious diseases, and others. Neurodegenerative diseases dominated the market in 2020 owing to the growing sales for multiple sclerosis as well as Alzheimer’s disease drugs due to the rising prevalence of neurological disorders.”  In addition to growing addiction issues, the article continued: “Furthermore, rising cases of mental health disorders among the population owing to increased stress levels, anxiety, and unhealthy diet are also leading to a growing demand for CNS therapeutics. Due to the emergence of COVID-19, mental health disorders have taken a steep climb among the population worldwide, therefore, increasing the sales of antidepressants, analgesics, and others.”  Active Companies in the markets today include SciSparc Ltd. (NASDAQ: SPRC), Biogen Inc. (NASDAQ: BIIB), Amgen (NASDAQ: AMGN), COMPASS Pathways plc (NASDAQ: CMPS), Denali Therapeutics Inc. (NASDAQ: DNLI).

“Based on drug type, the global market has been segmented into biologics and non-biologics. The non-biologics segment dominated the global market in 2020. The dominance is attributable to the lesser imposition of regulations by the regulatory body than that of the biologics for approval. Moreover, factors such as the presence of potential pipeline candidates and government support in the development and approval of the biologic CNS drugs are expected to foster the growth of the biologics segment.”

SciSparc Ltd. (NASDAQ: SPRC) BREAKING NEWS:  SciSparc Ltd. Announces Initial Positive Results for the Cocaine Addiction Treatment of Clearmind Medicine Inc. –  SciSparc Ltd., 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 initial positive pre-clinical results for treatment for cocaine addiction using MEAI, a novel psychedelic molecule of Clearmind Medicine Inc. (“Clearmind”) (CSE: CMND), (OTC: CMNDF), (FSE: CWY0).

Pursuant to SciSparc last announcement on June 2, 2022, whereby the Company announced the collaborated filing of a provisional patent application related to treating cocaine addiction with Clearmind based on SciSparc’s CannAmide compound and Clearmind’s MEAI, the pre-clinical trials show possible positive results which may positively affect our collaboration.

“We are excited about Clearmind’s results, in light of the potential synergistic effect between SciSparc’s CannAmide compound and Clearmind’s MEAI, as previously demonstrated in joint studies, which reflected the dose dependency effect. We plan to continue to investigate these findings, which for the first time point to a potential treatment for cocaine addiction. Since commencing the collaboration with Clearmind, we have been able to present successful results for our proprietary combination treatment” commented Oz Adler, SciSparc’s Chief Executive Officer. “It is our intention to further investigate the effect of this treatment on different addictions and other binge behaviors”.

The pre-clinical trial was led by Professor Gal Yadid and his team from the Gonda Multidisciplinary Brain Research Center located at Bar Ilan University (Ramat Gan, Israel) and was designed to evaluate the possible reward-like effects of MEAI. Four different doses of MEAI were compared to cocaine in the conditioned place preference (CPP) model in male Sprague-Dawley rats. Rats received either MEAI or cocaine. Based on statistically significant reductions in the reward effect as compared to cocaine, it was determined that MEAI is not rewarding. Additionally, some rats that received cocaine were treated with MEAI on the test day to determine if MEAI has a treatment-like effect. Rats were conditioned with cocaine and on the day of the test were treated with MEAI. The results obtained suggest MEAI’s ability to abolish cocaine induced conditioned place preference. The results of this ground-breaking research show potential for the first dedicated cocaine addiction treatment.   CONTINUED…  Read this full release for SciSparc at:  https://investor.scisparc.com/press-releases/

Other recent developments in the biotech industry include:

Biogen Inc. (NASDAQ: BIIB) and Alectos Therapeutics recently have entered into a license and collaboration agreement to develop and commercialize a novel preclinical selective GBA2 inhibitor, AL01811, which has first-in-class potential as an oral disease modifying treatment for patients with Parkinson’s disease (PD). This collaboration combines Alectos’ expertise in small-molecule therapeutics with Biogen’s development capabilities in movement disorders.

Increasing evidence suggests that lysosomal dysfunction plays a key role in the pathology of neurodegenerative disease, including PD. Small-molecule GBA2 inhibitors have been shown to reduce lysosomal pH and increase levels of the lysosomal proton pump vATPase, which is involved in maintaining the acidic pH required for lysosomal function. Currently, there are no approved disease modifying therapies for PD, creating significant unmet needs for patients seeking to slow disease progression. If approved, AL01811 has the potential to improve the standard of care for movement disorders such as PD, which affects approximately 10 million patients worldwide.

Amgen (NASDAQ: AMGN) recently announced that the U.S. Food and Drug Administration (FDA) has approved RIABNI (rituximab-arrx), a biosimilar to Rituxan^®, in combination with methotrexate for adults with moderate to severely active rheumatoid arthritis (RA) who have had an inadequate response to one or more tumor necrosis factor (TNF) antagonist therapies. RIABNI is already approved for the treatment of adult patients with Non-Hodgkin’s Lymphoma (NHL), Chronic Lymphocytic Leukemia (CLL), Granulomatosis with Polyangiitis (GPA) (also called Wegener’s Granulomatosis) and Microscopic Polyangiitis (MPA).

“The approval of RIABNI is an important advancement for adults living with moderate to severe rheumatoid arthritis, a chronic inflammatory joint disease, who now have access to a proven and affordable treatment option,” said Murdo Gordon, executive vice president of Global Commercial Operations at Amgen. “Our fully integrated portfolio of innovative and biosimilar medicines for inflammatory diseases reinforces our commitment to providing patients with high-quality and affordable treatment options that deliver substantial value to our healthcare system.”

COMPASS Pathways plc (NASDAQ: CMPS), a mental health care company dedicated to accelerating patient access to evidence-based innovation in mental health, recently presented positive data from the largest randomised, controlled, double-blind study of psilocybin therapy ever completed, at the American Psychiatric Association annual meeting in New Orleans*. The study showed that a single 25mg dose of COMP360 psilocybin, in combination with psychological support, was associated with a highly statistically significant reduction in depressive symptoms after three weeks (p<0.001), with a rapid and durable response for up to 12 weeks.

The randomised, controlled, double-blind phase IIb clinical trial was designed to understand the efficacy and safety of a single dose of investigational COMP360 psilocybin (25mg or 10mg), compared to 1mg in patients with treatment-resistant depression (TRD). 233 patients with TRD received either 1mg, 10mg or 25mg COMP360 psilocybin, in conjunction with psychological support from specially trained therapists. Symptoms of depression were assessed using the Montgomery-Åsberg depression rating scale (MADRS)**, a widely used and accepted scale for assessing depression; the MADRS assessments were made by an independent, blinded rater.

Denali Therapeutics Inc. (NASDAQ: DNLI), and Biogen Inc. (BIIB) recently announced that dosing has commenced in the global Phase 2b LUMA study to evaluate the efficacy and safety of BIIB122 (DNL151), as compared to placebo in approximately 640 participants with early-stage Parkinson’s disease.  LUMA is a Phase 2b multi-center, randomized, double-blind, placebo-controlled study to evaluate safety and efficacy of BIIB122 in people with early-stage Parkinson’s disease between the ages of 30 and 80. The primary endpoint of LUMA is Time to Confirmed Worsening in Movement Disorder Society Unified Parkinson’s Disease Rating Scale (MDS-UPDRS) parts II and III combined score over the treatment period. Participants will be randomized to receive oral BIIB122 or placebo once daily.

“More than 10 million people worldwide are affected by Parkinson’s disease, and there is a significant medical need for therapies to slow or stop the progression of this devastating neurodegenerative disease,” said Carole Ho, M.D., Chief Medical Officer at Denali. “Initiation of the LUMA study marks an important milestone in the development of BIIB122 as a potentially first-in-class oral LRRK2 therapy for Parkinson’s disease. We look forward to continuing our collaboration with Biogen and the Parkinson’s community in our unified goal to develop BIIB122 as a potential treatment option for people and families living with Parkinson’s disease.”

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