Pasithea Announces Interim PD Data From Ongoing Phase 1 Trial Of PAS-004 In Advanced Cancer Patients; PAS-004 Shows Up To 91% Inhibition Of pERK, Confirming Substantial Target Engagement

-- PAS-004 shows up to 91% inhibition of pERK, confirming substantial target engagement --

-- One patient in cohort 4A with stage 4 KRAS G12R mutated pancreatic cancer achieves over 5 months of stable disease with tumor volume reduction of -9.8% --

MIAMI, May 06, 2025 (GLOBE NEWSWIRE) -- Pasithea Therapeutics Corp. (NASDAQ:KTTA) ("Pasithea" or the "Company"), a clinical-stage biotechnology company developing PAS-004, a next-generation macrocyclic MEK inhibitor for the treatment of neurofibromatosis type 1 (NF1) and other MAPK pathway driven cancer indications, today announced positive interim pharmacodynamic (PD) data from its ongoing Phase 1 trial of PAS-004 in advanced cancer patients. The data includes results from cohorts 3 and 4A, evaluating 8mg and 15mg capsules, as well as cohort 4B evaluating 4mg tablets, and demonstrates strong target engagement consistent with PAS-004's favorable pharmacological profile.

Inhibition of ERK phosphorylation (pERK) is widely recognized as a gold-standard PD biomarker for assessing MEK inhibitor activity. To evaluate target engagement, pERK levels were measured in peripheral blood mononuclear cells (PBMCs) collected from patients at baseline and steady-state at day 22.

Preliminary results demonstrate robust pERK inhibition, with reductions in pERK levels of up to 91% even at the 8mg dose level, in line with a previous developed PK/PD model, confirming substantial target engagement in patients receiving PAS-004.