Palm Beach, FL –– February 3, 2022  – FinancialNewsMedia.com News Commentary – Multiple Sclerosis (MS) is an immune-mediated disease of the central nervous system. It is characterized by demyelination, inflammation, and degenerative changes such as progressive brain and spinal cord atrophy, neuroaxonal loss, and others. According to the Multiple Sclerosis Trust, 2.5 million people in the world were estimated to have MS in 2017. In addition to this, the treatment cost of MS has become an economic burden in many countries. According to the Institute for Clinical and Economic Review, the annual cost of treatment in the U.S. is estimated to be USD 28,000.0 million. Hence, there is active government support for the treatment in terms of better healthcare spending, expert recommendations, and drug approvals.  A report from Fortune Business Insights, projected that the global multiple sclerosis drugs market size was USD 26.05 billion in 2020. It continued: “The global impact of the COVID-19 has been unprecedented and staggering, with multiple sclerosis drugs witnessing a moderate negative demand shock across all regions amid the pandemic. Based on our analysis, the global market exhibited a growth rate of 4.2% in the year 2020, which is lower as compared to the previous years. The market value is USD 27.38 billion in 2021 and is expected to reach USD 41.99 billion in 2028 at a CAGR of 6.3% in the 2021-2028 period. The sudden rise in CAGR is attributable to the market’s demand and growth, returning to pre-pandemic levels once the pandemic is over.”  Active Biotechs in the markets today include:  Pasithea Therapeutics Corp. (NASDAQ: KTTA), Novartis AG (NYSE: NVS), Sanofi (NASDAQ: SNY), TG Therapeutics, Inc. (NASDAQ: TGTX), Evelo Biosciences, Inc. (NASDAQ: EVLO).

The report said: “The major depressive disorder segment by depressive disorder is projected to account for the significant share over the forecast period and North America has been dominant and is projected to have significant share in the global market.  The increasing cases of depression are one of the major factors that are expected to drive the overall growth of the antidepressant market in North America, particularly in the United States over the forecast period. Moreover, there is a rise in the geriatric population in the United States, which is expected to create more opportunities for market players in the region.   Additionally, the growing FDA approvals and increasing pipeline products by key players concentrated in the region drive the studied market. For instance, in March 2019, the US FDA approved Spravato (esketamine) nasal spray, in conjunction with an oral antidepressant, for the treatment of resistant depression in adults. Thus, in view of the aforementioned factors, the antidepressant market is expected to witness significant growth over the forecast period in North America.”

Pasithea Therapeutics Corp. (NASDAQ: KTTA) Breaking News: Pasithea Therapeutics Initiates New Chemical Entity Drug Development Program in Multiple Sclerosis — Company commences program to develop a tolerizing vaccine and names Hooke Laboratories as its research partner —  Pasithea erapeutics Corp. (Pasithea” or the “Company”), a biotechnology company focused on the research and discovery of new and effective treatments for psychiatric and neurological disorders, today announced a new chemical entity (“NCE”) development program and named Massachusetts-based Hooke Laboratories as its research partner.

The Company aims to develop a tolerizing vaccine for multiple sclerosis (“MS”), a potentially disabling autoimmune disease in which the immune system attacks myelin, the protective sheath that surrounds nerves in the brain and spinal cord. MS affects an estimated 2.8 million people worldwide. Preclinical work will be conducted at Hooke Laboratories, a full-service Contract Research Organization (“CRO”) with deep experience in experimental autoimmune encephalomyelitis (“EAE”), the standard animal model of MS.

Pasithea’s Chairman, National Academy of Sciences Professor Lawrence Steinman, will help lead the program. Prof. Steinman is a world recognized leading authority in MS, and his research led to the development of the drug Tysabri, which is approved to treat patients with MS and Crohn’s disease.

“Our decision to initiate a program in MS is a strong strategic fit and a natural progression of our work and mission,” stated Dr. Tiago Reis Marques, Chief Executive Officer of Pasithea Therapeutics. “Prof. Steinman’s expertise, along with our capabilities in central nervous system disorders, position us well to develop a new approach for the treatment for MS.”

“Our goal is to develop a tolerizing vaccine with a favorable safety profile and high efficacy, following on recently discovered mechanistic links driving the pathophysiology of MS,” stated Prof. Lawrence Steinman, Chairman of Pasithea Therapeutics. “The clinical potential of this strategy is large and exciting, as it can provide a novel method of treating a fundamental cause of the disease.”

“Hooke is the world’s most experienced EAE CRO, and we are delighted to be working with Pasithea to advance this important research program,” said Suzana Marusic, MD, PhD, Hooke’s founder and a pioneer in the development of adoptive transfer EAE models in C57BL/6 mice.  CONTINUED…  Read the Pasithea Therapeutics full press release by going to:  https://ir.pasithea.com/

In other biotech news in the markets this week: 

Novartis AG (NYSE: NVS) recently commenting on 2021 results, Vas Narasimhan, CEO of Novartis, said: “Novartis delivered another year of solid operational performance with mid-single digit top-line growth, margin expansion, and strong free cash flow. Our in-market growth drivers continue to perform well across geographies, supporting our confidence in our mid and long-term growth outlook. Despite some pipeline setbacks, we delivered important innovation milestones including for: Entresto, ¹⁷⁷Lu-PSMA-617, iptacopan, Kisqali, and Leqvio. Looking ahead, we are focused on delivering on our pipeline and key technology platforms, which includes 20+ potential assets with significant sales, to be approved by 2026. We remain balanced in our capital allocation priorities as we continue to invest in innovation alongside returning capital to our shareholders”.

Novartis is a focused medicines company. During 2021 we continued to build depth in five core therapeutic areas (Cardio-Renal, Immunology, Neuroscience, Oncology and Hematology), strength in technology platforms (Targeted Protein Degradation, Cell Therapy, Gene Therapy, Radioligand Therapy, and xRNA), and have a balanced geographic footprint. Our confidence to grow sales in the near-term is driven by multi-billion-dollar sales from: Cosentyx, Entresto, Kesimpta, Zolgensma, Kisqali and Leqvio. To fuel further growth through 2030 and beyond, we have 20+ new assets with at least USD 1 billion sales potential, that could be approved by 2026. Novartis is also pioneering the shift to advanced technology platforms.

Sanofi (NASDAQ: SNY) recently announced a second Phase 3 trial evaluating Dupixent^® (dupilumab) in adults with uncontrolled prurigo nodularis, a chronic type 2 inflammatory skin disease, met its primary and key secondary endpoints, showing it significantly reduced itch and skin lesions compared to placebo at 24 weeks in this investigational setting. The data confirm the positive results that were previously reported from the Phase 3 PRIME2 trial and will be submitted to regulatory authorities around the world starting in the first half of this year. The impact of prurigo nodularis on quality of life is one of the highest among inflammatory skin diseases due to the extreme itch.

“These results strengthen our understanding of the underlying biology of prurigo nodularis and are encouraging as we seek to help patients severely impacted by symptoms like unbearable itch, skin lesions, stinging and burning,” says Naimish Patel, M.D, Head of Global Development, Immunology and Inflammation at Sanofi. “We are committed to researching the science behind type 2 inflammation to advance and shift perceptions in a number of inflammatory skin diseases that are not well-understood. The decision to accelerate directly into a Phase 3 clinical trial for prurigo nodularis was driven by our conviction that type 2 inflammation is a key driver of this highly pruritic disease and underscores our commitment to quickly bring novel treatments to patients who are in urgent need of new options.”

TG Therapeutics, Inc. (NASDAQ: TGTX) recently announced two data presentations, highlighted data from the UNITY-CLL Phase 3 trial evaluating the combination of ublituximab, the Company’s investigational anti-CD20 monoclonal antibody and UKONIQ (umbralisib), the Company’s inhibitor of PI3K-delta and CK1-epsilon, (U2), in patients with both treatment naïve and relapsed or refractory chronic lymphocytic leukemia (CLL). Data presentations occurred yesterday evening during the 63^rd American Society of Hematology (ASH) annual meeting and exposition.

Michael S. Weiss, Chairman and Chief Executive Officer of TG Therapeutics stated, “We are pleased to share two presentations last night at the ASH annual meeting which included additional analyses of the UNITY-CLL Phase 3 trial evaluating the U2 combination in patients with both treatment naïve and relapsed or refractory CLL. We believe these presentations showcase the versatility of the U2 combination both by treatment subgroup, and also interestingly in a patient population generally characterized as unsuitable for BTKi-based therapy. While significant advances have been made in the treatment of CLL, there still remains underserved patients who may not be good candidates for or fail to respond to currently available treatments.”

Evelo Biosciences, Inc. (NASDAQ: EVLO), a clinical stage biotechnology company developing SINTAX medicines as a new modality of orally delivered treatments for inflammatory disease, recently announced data for EDP1815, the Company’s lead product in inflammation, detailing its mechanism of action and supporting further clinical development in patients with psoriasis and atopic dermatitis. The data were presented in two posters on Saturday, January 15, 2022, at the 2022 Winter Clinical Dermatology Congress in Koloa, Hawaii.

“The data presented today build on the substantial evidence accumulated through our clinical and preclinical work, deepening our understanding of the mechanism by which EDP1815 drives its clinical effects. They explain how an oral, gut-restricted SINTAX medicine can interact with the immune system in the gut, leading to systemic inflammation resolution without immunosuppression or concerning side-effects,” said Douglas Maslin, M.Phil, M.B. B.Chir, Dermatology and Pharmacology Physician at Addenbrooke’s Hospital and Immunology Clinical Lead of Evelo. “We are particularly pleased to share these results with the clinical community as we progress EDP1815 into later stages of development for the treatment of psoriasis and atopic dermatitis, two inflammatory diseases that affect millions of people worldwide.”

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