Palm Beach, FL – May 24, 2022 – FinancialNewsMedia.com News Commentary – The Global psychedelic drugs market has been steadily rising for the past few years and is projected to continue at a faster pace in years to come. The rising prevalence of mental depression and anxiety and availability of off label drugs are the major drivers which propelled the demand of the market in the forecast period. Psychedelic drugs involve various types of chemical substances including LSD and chemical extracted from plants. Psychedelic drugs have the ability to change or enhance the sensory perceptions, thought processes, energy levels and have also been reported to facilitate spiritual experiences. Psychedelic drugs can be categorized into empathogens and dissociative drugs (such as PCP) and serotonergic (classic hallucinogens) such as LSD. Both the types of psychedelic drugs can cause hallucinations and feeling of sensation, moreover, dissociative drugs can make a person to fell out of control from their body or environment and makes them feel disconnected. Based on the source, psychedelic drugs have been categorized under natural and synthetic types. These drugs have wide applications in the treatment of major depressive disorder, post-traumatic stress disorder, panic disorder, treatment-resistant depression and opiate addiction among others. Psychedelic drugs are also known by several other names such as LSD (lysergic acid derivative) which are also known as blotter, dots, sugar, acid, trips and window pane, ketamine are also known as vitamin K, bump, green, K/special K, purple and super acid, PCP are also known as angel/angel dust, boat/love boat, peace, killer weed, super grass and ozone.  Active Companies in the markets today include SciSparc Ltd. (NASDAQ: SPRC), Intercept Pharmaceuticals, Inc. (NASDAQ: ICPT), Cassava Sciences, Inc. (NASDAQ: SAVA), SIGA Technologies, Inc. (NASDAQ: SIGA), AbbVie (NYSE: ABBV).

A recent report from Data Bridge Market Research projected that the Global psychedelic drugs market is expected to gain market growth in the forecast period of 2022 to 2029. Data Bridge Market Research analyses that the market is growing with a CAGR of 13.3% in the forecast period of 2022 to 2029 and is expected to reach USD 8,020.01 million by 2029 from USD 2,992.51 million in 2021.  The report said: “On the basis of source, the global psychedelic drugs market is segmented into synthetic and natural. In 2022, the synthetic segment is expected to dominate the global psychedelic drugs market as most of the products are made from chemicals that are man-made with very few products (such as psilocybin) made from natural ingredients.”

SciSparc Ltd. (NASDAQ: SPRC) BREAKING NEWS:  SciSparc and Clearmind Medicine Inc. Collaboration Yields Positive Results for its Psychedelic Combination Treatment  –  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 positive safety profile results from its joint pre-clinical trial with Clearmind Medicine Inc. (“Clearmind”) (CSE: CMND), (OTC: CMNDF), (FSE: CWY0), a psychedelic pharmaceutical company focused on the discovery and development of novel psychedelic-derived therapeutics to solve widespread and underserved health problems. The trial tested the proprietary combination of SciSparc’s CannAmide with Clearmind’s psychedelic molecule, MEAI, for alcohol consumption.

A histopathology assessment was conducted on several organs (heart, lungs, liver, kidneys, brain, pancreas, spleen, and thyroid gland) from all experiment groups (n=3-5 per group) to determine the safety of the proprietary combination of MEAI and CannAmide versus control (mice) that were not exposed to alcohol). The severity of changes was scored by a 5-point scale by a qualified blinded toxicologist (Schafer et al., Toxicol Pathol 2018, 46:256-265). The results indicated a high safety profile of the combination treatment with no treatment-related changes observed.

Oz Adler, SciSparc’s Chief Executive Officer, commented, “We are pleased with these latest results that confirm the high safety profile of the psychedelic combination treatment. Previous testing results showed high efficacy potential in treating alcoholism when using this combination. We plan on further exploring the safety and efficacy of combining our technology with Clearmind’s novel molecule.”

Previously announced successful results showed a significant dose dependent effect for the MEAI treatment in reducing alcohol consumption in treated animals, with additional significant effect when combining CannAmide with the lower sub-effective MEAI dose.

Results showed that alcohol consumption was significantly reduced following treatment with MEAI at a dose of 40 mg/kg and higher (p<0.01) compared to consumption before treatment. Alcohol consumption was significantly reduced following dual treatment with 25 mg/kg CannAmide in addition to MEAI at a dose of 20 mg/kg compared to consumption before treatment. The mice were provided with 20% alcohol solution for 24 hours, three times a week, for seven weeks, and were treated every day with MEAI or MEAI/CannAmide during the last two weeks of alcohol treatment. The alcohol consumption was measured by weighing the alcohol bottles before and after; water consumption was measured similarly in parallel.  CONTINUED…  Read this full release for SciSparc at:  https://investor.scisparc.com/press-releases/

Other recent developments in the biotech industry include:

Intercept Pharmaceuticals, Inc. (NASDAQ: ICPT) recently announced the first patient has been dosed in a Phase 2 study evaluating a fixed-dose combination of obeticholic acid (OCA) and bezafibrate (BZF) for the treatment of patients with primary biliary cholangitis (PBC) who have not achieved an adequate biochemical response to ursodeoxycholic acid.

“Intercept is building on its legacy of innovation with the OCA-BZF fixed-dose combination, the first investigational therapy of its kind in PBC,” said M. Michelle Berrey, M.D., M.P.H., President of Research & Development and Chief Medical Officer of Intercept. “We believe OCA and BZF have synergistic mechanisms of action that can potentially provide additional benefits to people with PBC when used in combination. Additionally, both medicines have been shown to help lower the key biochemical measures that predict long-term outcomes in PBC. BZF has also been associated with improvements in pruritus, a potential benefit we are exploring in our Phase 2 program.”

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.

“We’re seeing an uptick in the rate of patient enrollment,” said Remi Barbier, President & CEO. “In part, the pandemic challenged some clinical sites, from staffing shortages to operational gaps. We hope these challenges are in the rearview mirror as we continue to move forward with our Phase 3 studies of simufilam in Alzheimer’s disease, while keeping an eye on the balance sheet.”

SIGA Technologies, Inc. (NASDAQ: SIGA) recently announced that the U.S. Food and Drug Administration (FDA) approved the intravenous (IV) formulation of TPOXX for the treatment of smallpox. The IV formulation is an important option for those who are unable to swallow the oral capsules of TPOXX.

“We are grateful to the FDA for their work leading to approval of IV TPOXX, which will provide access to a broader patient population,” said Dr. Dennis Hruby, CSO of SIGA. “We are also appreciative to our colleagues at BARDA who have been working with us for many years to include oral and IV TPOXX in U.S. preparedness efforts and look forward to continuing to work with them on our liquid pediatric formulation.”

AbbVie (NYSE: ABBV) recently announced it will present positive data from a Phase 3 trial of cariprazine (VRAYLAR^®; 1.5mg/day), Study 3111-301-001, for the adjunctive treatment of major depressive disorder (MDD) in patients with an inadequate response to ongoing antidepressant therapy. The study met its primary endpoint of statistically significant improvement using the Montgomery-Åsberg Depression Rating Scale (MADRS) total score in patients compared with placebo. These results will be presented (Poster Number: P7-037) on Tuesday, May 24, at the American Psychiatric Association (APA) Annual Meeting in New Orleans.

AbbVie’s supplemental New Drug Application (sNDA) for cariprazine was supported by two positive registration-enabling studies, of which one was Study 3111-301-001. The sNDA is currently under review by the U.S. Food and Drug Administration (FDA) for expanded use in the adjunctive treatment of MDD with a decision expected by year-end.

“We are pleased to present these data demonstrating cariprazine’s potential to have an impact on patients as an adjunctive treatment of major depressive disorder,” said Michael Gold, M.D., therapeutic area head, neuroscience development, AbbVie. “The results from this study, along with previously reported data, served as the basis of our recent sNDA submission to the FDA and further underpin AbbVie’s commitment to advancing innovative psychiatric therapies for patients in need.”

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