Pasithea Therapeutics Advances ALS Treatment with New Lead Candidate PAS-003 Targeting α5β1 Integrin

Pasithea Therapeutics Corp. KTTA, based in Miami Beach, Florida, is making significant strides in the biotechnology field by announcing its selection of PAS-003 as the lead development candidate for tackling amyotrophic lateral sclerosis (ALS). This fully humanized monoclonal antibody (mAb) directly targets α5β1 integrin, a key protein implicated in both sporadic and familial forms of ALS.

Understanding α5β1 Integrin as a Therapeutic Target

α5β1 Integrin plays a crucial role in the progression of ALS, and studies have demonstrated that its inhibition can lead to improvements in motor function and enhanced survival, particularly in the SOD1^G93A mouse model of the disease. The selection of PAS-003 follows thorough screenings and characterizations of multiple mAbs to determine the most effective compound for ALS treatment.

Preclinical studies have consistently shown promising results, with PAS-003 positively impacting behavior and survival rates in ALS mouse models. These findings are particularly significant as they offer hope for a condition that affects approximately 30,000 patients in the United States alone, with 5,000 new cases diagnosed annually. With life expectancy post-diagnosis falling between three to five years, new therapies are urgently needed.

New Horizons for ALS Patients

PAS-003 stands out for its potent inhibition of fibronectin (FN), the primary ligand for α5β1, suggesting a direct mechanism for modifying disease progression. The antibody displays high affinity and specificity, attributes critical for effectiveness and safety in potential treatments.

Dr. Tiago Reis Marques, CEO of Pasithea, has expressed optimism regarding the potential of PAS-003 to transform the treatment landscape for both sporadic and familial ALS. Leveraging collaborations with esteemed institutions like the Mayo Clinic and Oregon Health Sciences University, the company has laid a solid foundation for advancing this groundbreaking therapy to clinical trials.

Fuelled by substantial preclinical data and strong patent filings, PAS-003 is ready to embark on manufacturing and IND-enabling (Investigational New Drug) studies, marking a pivotal development milestone in Pasithea's efforts to combat CNS disorders.

Monoclonal Antibodies: A Beacon of Hope for Neurodegenerative Diseases

Pasithea's Chairman, Dr. Lawrence Steinman, who holds an endowed chair in Neurology at Stanford University, expressed his enthusiasm for PAS-003. Drawing parallels to his seminal work on integrins and multiple sclerosis, he highlights the potential for PAS-003 to become an effective treatment for ALS.

Pasithea Therapeutics remains at the forefront of CNS-focused biotech companies, committed to addressing the dire need for new ALS treatments as current FDA-approved medications offer limited efficacy in slowing disease progression.

In their relentless pursuit of innovative treatments for CNS disorders, including ALS, Pasithea stands as a beacon of hope for patients and their families, demonstrating the profound impact targeted biotechnological interventions can have on improving the human condition.

Caution Regarding Forward-Looking Statements

It's important to note that Pasithea's forward-looking statements, including expectations regarding PAS-003, involve assumptions and are subject to numerous conditions and uncertainties, which are detailed in the company’s SEC filings. These statements are crafted with the best information available and reflect the company’s predictions, but actual results may differ materially.

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