Pasithea Therapeutics announced positive interim Phase 1 data for PAS-004 in advanced cancer patients with RAS, NF1, or RAF mutations.
Significant clinical activity and favorable safety profile were observed in the study, indicating the potential of PAS-004 as a MEK inhibitor for NF1 treatment.
Monotherapy Activity
Partial response and stable disease observed in advanced melanoma patients with BRAF V600E mutation on PAS-004 for over 6 months.
Safety and Pharmacokinetics
PAS-004 demonstrated favorable safety profile with all treatment-related adverse events Grade 1 or 2, and dose-proportional pharmacokinetics with promising drug exposure levels.
Best-in-Class MEK Inhibitor
Emerging as a potential best-in-class MEK inhibitor for NF1 treatment with differentiated candidate features and early signals of efficacy.
- The interim results show promising clinical activity of PAS-004 in advanced cancer patients, especially in BRAF-mutated tumors.
- The favorable safety profile and drug exposure levels suggest potential for sustained pathway inhibition and meaningful clinical responses in NF1 patients.
The positive Phase 1 data of PAS-004 highlight its potential as a promising MEK inhibitor for the treatment of NF1, with early signs of efficacy, favorable safety profile, and potential for prolonged treatment duration.