Pasithea Therapeutics Selects PAS-003 Lead Development Candidate, a Humanized Monoclonal Antibody that Targets α5β1 Integrin for the Treatment of both Sporadic and Familial ALS - Seite 2

Dr. Lawrence Steinman, Chairman of Pasithea and the George A. Zimmermann Endowed Chair in the Neurology Department at Stanford University commented, “I have spent my career studying integrins and I believe α5β1 integrin is an important therapeutic target for the treatment of ALS. I am as excited about the PAS-003 development program as I was 30 years ago when I first published as senior author in Nature on targeting integrins for treating multiple sclerosis (MS). This original work led to the development of natalizumab (Tysabri), a monoclonal antibody that targets α4β1 integrin, that went on to become a disease modifying treatment for MS patients.” Dr. Steinman continued, “I would like to thank all of the parties involved, including the Mayo Clinic and Oregon Health Sciences University, who were influential in the discovery and research efforts, as well as Paul B. Manning and FightMND, a registered not-for-profit Australian charity, who helped fund the progress to our lead candidate selection.”

About PAS-003

PAS-003 is a fully humanized proprietary monoclonal antibody targeting α5β1 integrin for the treatment of both sporadic and familial amyotrophic lateral sclerosis (ALS) and other neurological diseases.

About Amyotrophic Lateral Sclerosis

ALS, or Lou Gehrig’s disease, is a fatal, progressive neurodegenerative disease that affects nerve cells in the brain and spinal cord, causing loss of muscle control. It most commonly affects people between the ages of 40 and 70, with an average age of 55 at the time of diagnosis. It affects as many as 30,000 patients in the United States, with 5,000 new cases diagnosed each year. The average life expectancy after diagnosis is three to five years, however ALS patients’ quality of life is typically poor. While approximately 5-10% of cases are hereditary caused by mutations in genes such as the superoxide dismutase 1 (SOD1) gene (familial ALS), the large majority of cases (90-95%) are sporadic and associated with mutations in the TAR DNA Binding Protein 43 kDa (TDP-43) gene (sporadic ALS). While the pathogenesis of ALS is not fully understood, studies have shown that the disease is multifactorial, with several interlinked mechanisms contributing to neurodegeneration, including neuroinflammation, which has been shown to play an important role in neurodegeneration. Currently there is no known cure or treatment that halts or reverses disease progression. There are currently six FDA approved medications to treat ALS and its symptoms, however, they have been shown to only modestly slow the progression of ALS. Therefore, despite these FDA approved therapies, the medical need for new treatments for ALS patients is very high.