Pasithea Therapeutics' Phase 1/1b Clinical Trial for PAS-004 in Adult NF1 Patients Continues with Positive Safety Review Committee Recommendation

Pasithea Therapeutics announced the enrollment of Cohort 2 in its Phase 1/1b clinical trial of PAS-004 for adult NF1 patients, following a positive Safety Review Committee recommendation to escalate to the next dose level of 8mg tablets. Initial interim clinical data from the first two cohorts is expected in Q1 2026.

Pasithea Therapeutics (NASDAQ: KTTA) has received approval to advance to Cohort 2 in its Phase 1/1b clinical trial of PAS-004, a next-generation macrocyclic MEK inhibitor for neurofibromatosis type 1 (NF1) patients. The external Safety Review Committee's recommendation follows a successful safety review of Cohort 1, where no dose limiting toxicities were observed in the initial three patients. The trial will now proceed with Cohort 2, testing an 8mg tablet dosage. The company has already enrolled the first three patients in this cohort, noting strong enrollment demand. Initial interim clinical data from the first two cohorts is expected in Q1 2026 [1].

The primary objective of the Phase 1/1b study (NCT06961565) is to evaluate the safety and tolerability of PAS-004 when administered for one 28-day treatment cycle in adult NF1 participants with at least one and up to two additional target plexiform neurofibromas (PNs) that are symptomatic and inoperable, incompletely resected, or recurrent. Secondary objectives include identifying the recommended Part B dose (RPBD) or Maximum Tolerated Dose (MTD) of PAS-004, characterizing the PK and PD profile of PAS-004, and evaluating its preliminary efficacy on target PN volume and associated symptoms [1].

Pasithea is a clinical-stage biotechnology company focused on developing PAS-004, a next-generation macrocyclic MEK inhibitor intended for the treatment of RASopathies, MAPK pathway-driven tumors, and other diseases. The company is currently testing PAS-004 in a Phase 1 clinical trial in advanced cancer patients (NCT06299839) and a Phase 1/1b clinical trial in adult patients with neurofibromatosis type 1 (NF1)-associated plexiform neurofibromas (NCT06961565) [1].

The trial is planned to be conducted at five clinical trial sites in Australia, South Korea, and the U.S. The study will be divided into two parts. In Part A, up to 24 eligible participants will be enrolled sequentially to receive one of four planned dose levels of PAS-004 tablets (4mg, 8mg, 12mg, 18mg) in a modified 3+3 design. Part A will identify the recommended RPBD. During Part B, approximately 24 eligible participants will be enrolled in parallel to receive one of two planned dose levels of PAS-004 tablets at the RPBD level and at a dose level below the RPBD for up to six continuous 28-day treatment cycles. Part B will identify the recommended phase 2 dose (RP2D) [1].

Pasithea Therapeutics Contact
Patrick Gaynes
Corporate Communications

References:
[1] https://www.stocktitan.net/news/KTTA/pasithea-therapeutics-announces-enrollment-of-cohort-2-following-pt9rywcc0dwu.html