Palm Beach, FL – June 22, 2022 – FinancialNewsMedia.com News Commentary Neuroinflammatory disorder is the study of conditions where immune responses which damage components of the nervous system. It includes many rare neurological disease disorders like Alzheimer’s disease, Parkinson’s disease and Multiple Sclerosis. It is also associated with aging and Traumatic brain injury. According to a report from Future market Insights, the majority of rare diseases at present have none or little effective procedures of diagnosis & treatment, which can be partly attributed to absence of funding toward researches on rare disease pathogenesis and lack of representative patients. Rare neurological disease are among major types of rare diseases with ineffective diagnoses and treatment options. According to WHO, 1 in 10 individuals are expected to be diagnosed with rare neurological disorder in their lifetime. Brain diseases are considered to be one of the major determinants of the neurological disease prevalence worldwide, with early intervention being the only key to prevent or curtail long-term morbidity and relevant healthcare costs. Spreading awareness about these diseases along with increasing their visibility are key initiatives taken by various governments worldwide for speeding up diagnostic processes and provide affected families with access to proper counselling and treatment options.  A recently published report of Future Market Insights foresees the global rare neurological disease treatment market to record a spectacular growth through 2026. Revenues from treatment of rare neurological disorders worldwide are poised to surpass US$ 12,000 Mn by 2026-end.  Active Biotechs in the markets today include:  Pasithea Therapeutics Corp. (NASDAQ: KTTA), Ionis Pharmaceuticals, Inc. (NASDAQ: IONS), Denali Therapeutics Inc. (NASDAQ: DNLI), Amylyx Pharmaceuticals, Inc. (NASDAQ: AMLX), Cytokinetics, Incorporated (NASDAQ: CYTK).

The report said: “In North America, rare neurological conditions are considered to a major healthcare concern, although fewer individuals are currently affected by the disease. Complexity of these diseases, along with their inadequacy in treatment options have led to disproportionate share of spending in healthcare. Drug companies in North America are conducting robust researches in rare diseases, however they face difficulties related to cost of treatment development related to small or geographically dispersed populations.  Government and healthcare institutes in North America are therefore collaborating to develop a robust research network, in order to facilitate data sharing, enrollment in trials & studies, and advancement in rare diseases. This will further influence the rare neurological disease treatment market in North America. The report estimates North America to remain the largest revenue contributor to the market.”

Pasithea Therapeutics Corp. (NASDAQ: KTTA) Breaking News: Pasithea Therapeutics Acquires Alpha-5 Integrin, LLC –  Alpha-5 is a potentially First-In-Class monoclonal antibody for the Treatment of Amyotrophic Lateral Sclerosis (ALS) and other neurological diseases – Pasithea erapeutics Corp. (Pasithea” or the “Company”) today announced its acquisition of Alpha-5 integrin, LLC (“Alpha-5”), a privately-held preclinical-stage company developing a monoclonal antibody (mAbs) for the treatment of amyotrophic lateral sclerosis (ALS) and other neuroinflammatory disorders, such as Multiple Sclerosis (MS).

Alpha-5’s lead therapeutic candidate has a novel mechanism of action with the potential to improve clinical outcomes in patients with ALS, supported by post-mortem studies and with reproducible significant improvement in behavior and survival in the SOD1 mice model. The acquisition includes Alpha-5 proprietary antibodies with novel IP and brings to Pasithea a group of seasoned scientists and a state-of-the-art laboratory.

The Company acquired all of the outstanding equity interests in Alpha-5 at an enterprise value for $3.75 million, payable in 3.26 million shares of Pasithea common stock, valued at $1.15 per share, a 11% premium to the closing price on June 21, plus 1 million warrants. An entity controlled by Paul B. Manning, Chairman and CEO of PBM Capital, a healthcare-focused investment firm, was Alpha-5’s majority owner and, following the transaction, owns approximately 10% of Pasithea common stock. Cassel Salpeter & Co provided financial advisor to Company on this transaction.

“This agreement with Pasithea represents the culmination of years of work by Alpha-5 researchers successfully leveraging their deep scientific expertise in the integrin space. We believe Pasithea to be well-positioned to apply its capabilities to move this asset forward and make an impact on ALS disease for the benefit of patients.” said Paul B. Manning.

“Treatments for ALS are extremely limited. Only two drugs are currently approved, with minimal impact on disease, and the majority of patients progress to death within a few years of symptom onset. The Alpha-5 acquisition is transformative for Pasithea by adding a new drug with a novel mechanism of action to our pipeline, while preserving our strong cash position. In addition to the Alpha-5 development program, we also acquire a wet lab and scientific team to develop our existing tolerizing vaccine and complement program. Our plan is to file an Alpha-5 investigational new drug application (IND) with an orphan drug designation by the end of 2023,” stated Dr. Tiago Reis Marques, CEO of Pasithea.

Stanford Professor Larry Steinman, Chair of the Board and co-founder of Pasithea and a minority owner of Alpha-5 said, “My work has been instrumental for the discovery of natalizumab, an anti-alpha 4 integrin mAb. This was the first drug developed in the class of selective adhesion molecule inhibitors and a potent therapeutic for multiple sclerosis. We believe that alpha-5 integrin antibody can also be transformative in the treatment of other neurological disorders, such as ALS or Multiple Sclerosis (MS). Post-mortem human studies and preclinical work conducted so far support this therapeutic target and we are excited to move it into clinical trials.” Professor Steinman recused himself from the vote to approve the transaction.  CONTINUED…  Read the Pasithea Therapeutics full press release by going to:  https://ir.pasithea.com/

In other biotech news in the markets this week: 

Ionis Pharmaceuticals, Inc. (NASDAQ: IONS) partner Biogen recently announced results from the Phase 3 VALOR study and its open-label extension (OLE) of tofersen, an investigational antisense medicine being evaluated for people with superoxide dismutase 1 (SOD1) amyotrophic lateral sclerosis (ALS). The data show that earlier initiation of tofersen, compared to delayed initiation, slowed declines in clinical function, respiratory function, muscle strength and quality of life. At the time of the analysis, because the majority of participants survived without permanent ventilation (PV), the median time to death or PV could not be estimated. However, early survival data suggest a lower risk of death or PV with earlier initiation of tofersen. These results are based on new integrated data from the VALOR pivotal study and its OLE study.

The results were presented at the European Network to Cure ALS (ENCALS) meeting in Edinburgh, Scotland. An archived version of the presentation will be available on the Investors section of Biogen’s website at investors.biogen.com.

Denali Therapeutics Inc. (NASDAQ: DNLI), and Biogen Inc. 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.”

Amylyx Pharmaceuticals, Inc. (NASDAQ: AMLX) recently announced that Health Canada has approved ALBRIOZA (sodium phenylbutyrate and ursodoxicoltaurine), with conditions, for the treatment of amyotrophic lateral sclerosis (ALS). Clinical data demonstrated a statistically significant and clinically meaningful benefit in functional outcomes for people with ALS taking ALBRIOZA (also known as AMX0035) compared to people taking placebo, either as a stand-alone therapy or when added to existing treatments for ALS. This decision marks the first marketing approval for ALBRIOZA issued to Amylyx worldwide.

“For nearly a decade, we have been committed to creating more meaningful moments for people living with ALS and their families. We are excited with Health Canada’s decision to approve ALBRIOZA with conditions. ALBRIOZA is a therapy that demonstrated in our CENTAUR trial a statistically significant and clinically meaningful impact on function, alone or in addition to existing ALS therapies. We are grateful to the people who participated in our clinical trials, their families, the researchers, and the ALS community for helping to make this milestone happen,” said Justin Klee and Joshua Cohen, Co-CEOs and Co-Founders of Amylyx.

Cytokinetics, Incorporated (NASDAQ: CYTK) recently announced the start of COURAGE-ALS OLE (Clinical Outcomes Using Reldesemtiv on ALSFRS-R in a Global Evaluation in ALS Open Label Extension), an open-label extension clinical study designed to assess the long-term safety and tolerability of reldesemtiv in people with amyotrophic lateral sclerosis (ALS). Patients will be eligible for COURAGE-ALS OLE after completing their participation in COURAGE-ALS, the Phase 3 clinical trial of reldesemtiv, a next-generation fast skeletal muscle troponin activator (FSTA) for the potential treatment of ALS.

“We are pleased to provide continued access to reldesemtiv through the open-label extension study of COURAGE-ALS as is aligned with our commitment to people with ALS. This open-label extension will also allow us to gather longer-term data related to the effect of treatment with reldesemtiv on disease progression in ALS,” said Fady I. Malik, M.D., Ph.D., Cytokinetics’ Executive Vice President of Research & Development. “Additionally, we look forward to opening a Managed Access Program for reldesemtiv later this year for participants who completed our prior ALS clinical trials. ALS is a devastating, fatal disease with few approved therapies, and we recognize the urgency to provide access to people who have committed to our extensive clinical research while we also advance reldesemtiv in our ongoing Phase 3 clinical trial”

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