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

-- Blocking of α5β1 integrin has been shown to improve motor function and increase survival in the SOD1^G93A mouse model of ALS --
-- Fully humanized anti-α5β1 monoclonal antibody is ready for manufacture and IND-enabling studies --

SOUTH SAN FRANCISCO, Calif. and MIAMI, Nov. 09, 2023 (GLOBE NEWSWIRE) -- Pasithea Therapeutics Corp. (NASDAQ: KTTA) (“Pasithea” or the “Company”), a biotechnology company focused on the discovery, research, and development of innovative treatments for central nervous system (CNS) disorders, announced today that it has selected a lead therapeutic candidate for its PAS-003 program, a proprietary humanized monoclonal antibody (mAb) that targets α5β1 integrin, a protein found to be overexpressed in both human and mouse subjects with amyotrophic lateral sclerosis (ALS).

Scientists at Pasithea have performed extensive mAb screening and characterization to enable selection of a lead therapeutic candidate with optimal properties for the treatment of ALS. This work included further validation of α5β1 integrin as a target in both familial (SOD1) and sporadic (TDP-43) ALS mouse models with reproducible improvements on behavior and survival. Extensive mechanism of action studies link disease model efficacy to effects on the migration and adhesion of immune cells. The humanized lead candidate is a potent inhibitor of the primary ligand fibronectin (FN), has been optimized for high affinity and has high (sub-nanomolar) specificity with contact sites directly adjacent to the FN binding site documented by cryogenic electron microscopy (cryo-EM).

Dr. Tiago Reis Marques, Chief Executive Officer of Pasithea commented, “We have chosen the most optimal anti-α5β1 humanized mAb for the treatment of both sporadic and familial ALS. PAS-003 is now ready for manufacturing and IND-enabling studies. In July 2023, in conjunction with scientists at the Mayo Clinic and Oregon Health Sciences University, we published a study in the renowned scientific peer-reviewed journal Proceedings of the National Academy of Sciences (PNAS) describing an increase of α5β1 integrin expression with disease progression in both mouse models of ALS and in human postmortem tissue samples of ALS patients. Additionally, this publication highlights the role of α5β1 integrin on different cell types involved in neuroinflammation in ALS and has shown that blocking α5β1 integrin is a therapeutic target for the treatment of ALS.” Dr. Marques continued, “We are pleased to have achieved this significant development milestone through extensive and repeated preclinical studies, to have made key patent filings and we are looking forward to introducing our PAS-003 program to partners to appropriately advance this important program to the clinic.”