R&D Efforts for Central Nervous System (CNS) Therapeutics Have Resulted in Hopeful Novel Drug-Delivery Solutions

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PALM BEACH, Fla., June 29, 2022 /PRNewswire/ -- In the central nervous system (CNS) therapeutics market, large and small pharmaceutical companies are highly investing in the development of novel therapies to treat central nervous system diseases. Regulatory guidelines and critical clinical trials are encouraging the entry of new products into the market for central nervous system therapeutic. These drugs are monitored for their efficacy, dosage, formulation, and aftereffects. A report from Grand View Research projected that the global central nervous system therapeutic market size is expected to expand at a compound annual growth rate (CAGR) of 7.4% from 2021 to 2028.  The report said: "Advancements in diagnostics and therapeutics of central nervous system (CNS) diseases are expected to increase the treatment rate globally. Moreover, the increasing prevalence of central nervous system disorders and the rising demand for effective therapeutics options are expected to boost market growth over the forecast years. According to a report published by the WHO, central nervous system disorders such as Alzheimer's disease, multiple sclerosis, epilepsy, Parkinson's disease, and stroke affect more than 1 billion people worldwide. The high unmet medical need has led all the major pharmaceutical companies to invest and develop novel therapies for the treatment of CNS diseases."  Active Companies in the markets today include SciSparc Ltd. (NASDAQ: SPRC), Denali Therapeutics Inc. (NASDAQ: DNLI), Sage Therapeutics, Inc. (NASDAQ: SAGE), Cassava Sciences, Inc. (NASDAQ: SAVA), Intercept Pharmaceuticals, Inc. (NASDAQ: ICPT).

Grand View Research continued: "The CNS therapeutics market has experienced extensive R&D efforts in the past decade, which have resulted in the introduction of novel drug-delivery systems. The advancements in the drug-delivery systems are expected to increase the adoption of a novel therapy to treat central nervous system diseases. These novel drug-delivery systems have an edge over conventional methods owing to reduced adverse effects. The demand for a novel drug-delivery system is owing to ease of delivery and availability of different dosage forms. For instance, the introduction of transdermal patches for central nervous system disorders provides an accurate amount of medicine and relief mostly for around 24 hours."

SciSparc Ltd. (NASDAQ: SPRC) BREAKING NEWS:  SciSparc Successfully Completed The Development of its Proprietary Drug Candidate SCI-110 for its Upcoming Phase IIb Study In Tourette Syndrome - SciSparc Ltd., a specialty, clinical-stage pharmaceutical company focusing on the development of therapies to treat disorders of the central nervous system, today announced that it has successfully completed the development of its top-tier drug candidate SCI-110 to be used in its upcoming multinational, multicenter, Phase IIb study for Tourette Syndrome ("TS"). 

The Company recently announced that it has received ethics committee approvals from Hannover Medical School in Hannover, Germany, and the Tel Aviv Sourasky Medical Center, in Tel Aviv, Israel. SCI-110 is developed and manufactured by Procaps Group S.A., a leader in contract development and manufacturing services in soft-gel advanced technologies for the global pharmaceutical industry.

"Completing the development of our unique drug candidate SCI-110 for the upcoming Phase IIb trial is another significant milestone for the Company, making SciSparc well positioned to introduce an impactful treatment for TS patients that have very limited treatment options today," commented Oz Adler, SciSparc's Chief Executive Officer. "Our singular objective in developing SCI-110 is to develop a safe and effective treatment for this devastating, unmet medical need as soon as possible; and this milestone brings us one step closer."

TS is a movement and neurobehavioral disorder characterized by chronic motor and vocal tics. With onset before age 18, about half to two-thirds of TS cases improve during adolescence, while adults are generally more severe patients. Tics may be associated with a premonitory sensation to perform a specific action, which may lead to "relief" once performed.

The objective of this Phase IIb randomized, multi-national, multi-center, double-blind, placebo controlled cross-over study is to evaluate the efficacy, safety and tolerability of SciSparc's proprietary drug candidate SCI-110 in adult patients (between 18 and 65 years of age) using oral treatment daily. The patients will be randomized in a 1:1 ratio to receive either SCI-110 or a SCI-110 matched placebo. The primary efficacy objective of the study will be to assess tic severity change using Yale Global Tic Severity Scale (YGTSS-R-TTS), the most commonly used measure in clinical trials, as a continuous endpoint at week 12 and week 26 of the double-blind phase compared to baseline. The primary safety objective of the study will be to assess absolute and relative frequencies of serious adverse events for the entire population and separately for the SCI-110 and placebo groups. The launch of the trial is pending approvals by the Ministry of Health in both Germany and Israel.   CONTINUED…  Read this full release for SciSparc at: https://investor.scisparc.com/press-releases/ 

Other recent developments in the biotech industry include:

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.

Sage Therapeutics, Inc. (NASDAQ: SAGE) and Biogen Inc. (BIIB) recently announced that the Phase 3 SKYLARK Study of zuranolone, an investigational oral drug being evaluated in women with postpartum depression (PPD), met its primary and all key secondary endpoints. Women treated with zuranolone 50 mg (n=98) demonstrated a statistically significant and clinically meaningful improvement in depressive symptoms at Day 15, the primary endpoint, compared to placebo (n=97) as measured by a change from baseline (CFB) in the 17-item Hamilton Rating Scale for Depression (HAMD-17) total score. The least-squares (LS) mean (SE) CFB in HAMD-17 total score at Day 15 for women who received zuranolone 50 mg was -15.6 (0.82) compared with -11.6 (0.82) for women who received placebo (LS mean difference -4.0 points; p=0.0007).

"Reducing suffering from postpartum depression as rapidly and effectively as possible to restore maternal mental health is of the utmost importance for moms and their babies," said Dr. Kristina Deligiannidis, principal investigator of the SKYLARK Study and Associate Professor, the Feinstein Institutes for Medical Research in Manhasset, New York. "These encouraging results are another important step in efforts to develop a novel treatment option for patients who suffer from this prevalent condition."

Cassava Sciences, Inc. (NASDAQ: SAVA), a clinical-stage biotechnology company focused on Alzheimer's disease, recently announced financial results for the first quarter ended March 31, 2022 and provided a clinical update on its Phase 3 clinical program of simufilam in Alzheimer's disease. Simufilam is Cassava Sciences' lead drug candidate for the proposed treatment of Alzheimer's disease.

Net loss was $17.5 million, or $0.44 per share, compared to a net loss of $3.5 million, or $0.09 per share, for the same period in 2021. Net cash used in operations was $23.5 million during the first quarter of 2022, including over $10 million of contractual pre-payments. Pre-payments are amounts paid for in advance of future research and development (R&D) services.

Intercept Pharmaceuticals, Inc. (NASDAQ: ICPT) recently announced results from two studies designed to evaluate clinical outcomes in patients with PBC on Ocaliva (obeticholic acid or OCA): COBALT, a Phase 3b/4 confirmatory clinical outcomes study, and HEROES-US, one of two HEROES real-world studies. Findings from these studies will be part of a broader evidence package being submitted to the U.S. Food and Drug Administration (FDA) in the second half of 2022.

Ocaliva was granted an accelerated approval in 2016 based on a reduction in alkaline phosphatase (ALP), a blood marker of liver injury. COBALT was designed to determine rates of clinical events in patients with advanced PBC and was initiated to support post-marketing requirements.

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