Pasithea reports 41% skin-tumor area reduction

Pasithea Therapeutics (NASDAQ:KTTA) reported initial Phase 1/1b results for its experimental drug PAS-004, showing a median best reduction of 41% in target cutaneous neurofibroma surface area across 15 evaluable participants.

At the 4mg, 8mg and 12mg doses planned for Phase 2, median best reduction reached 46%, while participants followed through 12 treatment cycles recorded a median reduction of 49%, rising to 71% in the 4mg cohort at Cycle 15.

All 18 evaluable participants with plexiform neurofibromas showed reductions in tumor volume, with two meeting the partial-response threshold, although one participant's 22.5% reduction remains subject to confirmation, while no treatment-related serious adverse events or treatment-related discontinuations were reported.

The ongoing open-label study enrolled 19 participants across six dose groups, while two Grade 3 increases in blood creatine phosphokinase, a muscle enzyme, required temporary dosing interruptions and subsequently resolved.

The FDA cleared the investigational new drug application for a randomized, double-blind, placebo-controlled Phase 2 trial involving approximately 200 adults with NF1-associated cutaneous neurofibromas, evaluating three once-daily doses of PAS-004 between 4mg and 12mg.