Pasithea amended its Phase 1/1b NF1 trial to add 24mg and 32mg PAS-004 dose levels, backfill cohorts and extend treatment to 18 months with MRI and CN measurements. It completed dosing of 4mg, 8mg, 12mg and 18mg cohorts, enrolled 15mg and 24mg groups, plans an interim NF1 data update in Q4 2026.
Pasithea increased Part A dose escalation to include 24mg and 32mg PAS-004 cohorts, backfilled earlier 4mg–18mg cohorts with up to two additional participants each and added intermediate dose evaluation.
The trial has completed multi-cycle dosing in 4mg, 8mg, 12mg and 18mg cohorts, has enrolled a 15mg intermediate cohort and initiated dosing in the 24mg cohort.
Treatment duration for Part A has been lengthened to up to 18 months per patient, with additional MRI scans for plexiform neurofibroma evaluation and detailed cutaneous neurofibroma height and volume measurements.
Pasithea expects to provide an interim NF1 data update in Q4 2026 to inform Part B dose selection and future registrational study design.
