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Pasithea Updates PAS-004 Clinical Trial Data

Pasithea Therapeutics announced updated interim safety and clinical activity 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, including patients who have failed prior BRAF/MEK inhibitor treatment. The company also announced details of its protocol amendment to extend dose escalation and initiate a pilot food effect assessment. In total, 34 patients have been enrolled and dosed. No dose-limiting toxicities and no discontinuations due to TRAEs with 10 patients on study for greater than 90 days, of which six patients greater than 150 days, for patients greater than 300 days, and two patients greater than 365 days. All TRAEs were Grade 1 or Grade 2; low cumulative rates of rash and diarrhea across all patients at all doses throughout the study, including no rash or diarrhea in the four patients on study greater than 300 days and two patients greater than 365 days and no events of retinal or cardiac toxicity. Multiple patients demonstrating durable clinical benefit and tumor shrinkage, including several MEK/BRAF-pretreated patients who have remained on study for greater than six months and two patients on study for over one year - exceeding the approximately five-month median PFS reported in the literature for BRAF/MEK rechallenge in this setting. The final PFS data will not be known until the end of the trial. The company plans to submit and present a more robust data set at a future scientific conference.

Pasithea Amends PAS-004 Clinical Trial Protocol

Pasithea Therapeutics announced it has amended the clinical study protocol for the Phase 1/1b trial of PAS-004 in neurofibromatosis type 1 patients with symptomatic inoperable, incompletely resected, or recurrent plexiform neurofibroma, or PN. The amendments include an update to the dose escalation part of the study to allow for the enrollment of additional participants at two additional higher dose levels, the ability to backfill completed dose cohorts with up to two participants, and the evaluation of intermediate dose levels. In addition, the protocol amendments allow patients to remain on treatment for up to 18 months in Part A, and include additional MRI scans to evaluate PN, as well as adding more detailed cutaneous neurofibroma, or CN, measurements, including tumor height and volume. Pasithea has completed enrollment and multi-cycle dosing of the initial 4mg, 8mg, 12mg and 18mg cohorts, and enrolled the 24mg cohort and an intermediate 15mg cohort.

Pasithea Therapeutics Receives Orphan Drug Designation for PAS-004

Pasithea Therapeutics announced that the FDA has granted Orphan Drug Designation to PAS-004 for the treatment of Amyotrophic Lateral Sclerosis, or ALS.