Pasithea Therapeutics announces interim data from PAS-004 trial

Pasithea Therapeutics (KTTA) announced interim Phase 1 data from its ongoing first-in-human trial evaluating PAS-004 in patients with MAPK pathway-driven advanced solid tumors with a documented RAS, NF1 or RAF mutation, or in patients who have failed prior BRAF/MEK inhibition. A BRAF V600E melanoma patient in Cohort 4A achieved an unconfirmed partial response with a 31.9% tumor reduction and remains on trial for greater than 11 months; prior best response when treated with a MEK + BRAF combination therapy was stable disease. Overall, 71.4% of patients identified with BRAF-mutated tumors achieved stable disease or partial response and 42.8% of patients achieved stable disease or partial response. A second BRAF V600E melanoma patient previously treated with MEK + BRAF combination therapy in Cohort 6 remains on trial for greater than 6 months with a stable disease and tumor shrinkage of 1.6%. PAS-004, dosed once daily, has been well-tolerated across all dose levels. No dose-limiting toxicities and no discontinuations have been reported. All treatment-related adverse events at least possible related to PAS-004 were Grade 1 or 2, with limited rash, nausea, vomiting, diarrhea and no ocular retinal abnormalities or cardiovascular toxicities observed.