Pasithea Therapeutics Reports Positive SRC Recommendation for PAS-004 Phase 1 Cancer Trial

Pasithea Therapeutics Corp., a clinical-stage biotechnology firm, has received a positive recommendation from its external Safety Review Committee to advance to the next stage of its Phase 1 clinical trial for PAS-004, a novel macrocyclic MEK inhibitor. This trial aims to explore treatment options for neurofibromatosis type 1 (NF1) and various cancer types. The committee's decision was based on an analysis of safety data from three patients participating in Cohort 5, confirming the absence of any dose-limiting toxicities (DLTs).

The trial plans to escalate to Cohort 6, which will involve administering a 30mg capsule formulation of PAS-004. Importantly, no instances of rash, a common side effect linked to low doses of competing MEK inhibitors, have been reported in any of the initial 19 participants, which include patients taking both the capsule (15) and tablet (4) forms of PAS-004. Rash can often lead to treatment discontinuation in clinical practice, highlighting the significance of these findings.

CEO Dr. Tiago Reis Marques expressed optimism about the trial's progress, noting the high demand for enrollment and the identification of participants for Cohort 6. The company is observing substantial exposure levels to PAS-004, with potential to maintain effective pERK inhibition below the no observed adverse effect levels (NOAEL), as seen in earlier nine-month chronic toxicity studies. Notably, in other approved MEK inhibitors for NF1, the occurrence of rash exceeds 80%, often resulting in patients discontinuing treatment prematurely.

The ongoing Phase 1 trial is a multi-center, open-label study employing a 3+3 dose escalation design. It is focused on assessing the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and initial efficacy of PAS-004 in individuals with advanced solid tumors driven by the MAPK pathway. Participants in the trial have documented RAS, NF1, or RAF mutations or have not responded to previous BRAF/MEK inhibition treatments.

Pasithea Therapeutics Corp. specializes in pioneering treatments for central nervous system (CNS) disorders and RASopathies. The company leverages a team of experts in neuroscience, translational medicine, and drug development to create new molecular entities. Their work focuses on neurological disorders such as Neurofibromatosis type 1 (NF1), Solid Tumors, and Amyotrophic Lateral Sclerosis (ALS).

Pasithea's commitment to innovation in biotechnology is evident in its efforts to develop next-generation treatments that address unmet medical needs. By advancing PAS-004 in their clinical trials, the company aims to offer new hope for patients with challenging conditions such as NF1 and various cancers, potentially transforming the therapeutic landscape for these diseases.