Pasithea Therapeutics (KTTA) Advances PAS-004 Clinical Trial to Next Dosing Group

Pasithea Therapeutics Corp. (KTTA), a biotech firm focused on developing innovative treatments for cancer and neurofibromatosis type 1 (NF1), announced today that it has been cleared to continue its Phase 1 study of PAS-004. The independent Safety Review Committee has advised the Company to move forward with Cohort 6, which will involve dosing patients with a 30mg capsule, with no changes to the trial protocol.

This decision follows an evaluation of safety data from three individuals in Cohort 5, during which no dose-limiting toxicities (DLTs) were recorded. Notably, none of the first 19 participants — 15 who received the capsule and four who were administered the tablet version of PAS-004 — have developed rashes within the DLT assessment period. This is significant since rash is a frequent side effect associated with other MEK inhibitors, even at lower doses, and often results in patients stopping treatment prematurely in clinical settings.

“We are seeing substantial enrollment demand and have already identified Cohort 6 patients. In addition, we continue to observe substantial exposure levels of PAS-004, and remain excited about the possibility of delivering relevant pERK inhibition below the no observed adverse effect levels (NOAEL) as we modeled and observed during our previously conducted nine-month chronic toxicity studies. The on label rash rate for both approved MEKi for NF1 exceeds 80% which leads to patients discontinuing who otherwise should remain on treatment for longer periods of time”, stated Dr. Tiago Reis Marques, Chief Executive Officer of Pasithea (KTTA). “We will provide additional safety, pharmacokinetic (PK) and pharmacodynamic (PD) data over the next several weeks.”

The Phase 1 clinical trial currently underway is a multi-center, open-label dose-escalation study that follows a 3+3 design. Its purpose is to assess the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and early indications of effectiveness of PAS-004. The trial includes patients with advanced solid tumors characterized by mutations in the MAPK pathway, including those with RAS, NF1, or RAF gene alterations, as well as individuals whose previous treatment with BRAF/MEK inhibitors was unsuccessful (NCT06299839).