– Initial interim safety, tolerability, biomarker, and preliminary efficacy data expected in Q1 2026 – MIAMI, July 31, 2025 (GLOBE NEWSWIRE) -- Pasithea Therapeutics Corp. (NASDAQ: KTTA) ("Pasithea" or the "Company"), a clinical-stage biotechnology company developing PAS-004, a next-generation macrocyclic MEK inhibitor for the treatment of neurofibromatosis type 1 (NF1) and other MAPK pathway driven indications, today announced the Company has completed enrollment and initial dosing of three subjects in Coh ...

- 94% OS and 72% PFS observed at 6 months for atebimetinib (IMM-1-104) in combination with modified Gemcitabine/nab-paclitaxel (mGnP), N=34; median OS and PFS not yet reached - - Striking tumor reductions with 39% overall response rate and 81% disease control rate observed as of the data cutoff, including many patients with deepening, durable regressions and multiple examples of individual lesions rendered undetectable - - Markedly favorable tolerability profile observed, demonstrating potential best-in-cla ...

Core Insights - Pasithea Therapeutics Corp. announced promising interim results for PAS-004, a next-generation macrocyclic MEK inhibitor, in a Phase 1 clinical trial targeting advanced cancer patients with MAPK pathway-driven tumors [1][6] Group 1: Clinical Trial Overview - The ongoing Phase 1 study employs a multi-center, open-label, dose escalation design to assess the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary efficacy of PAS-004 [1] - As of April 2, 2025, 21 patients have been enrolled across six cohorts, with pancreatic cancer (28.6%), colorectal cancer (28.6%), and melanoma (23.8%) being the most common diagnoses [2] Group 2: Efficacy and Safety - PAS-004 demonstrated a dose-dependent PK profile and preliminary clinical activity, with 10 out of 16 efficacy evaluable patients achieving stable disease at some point during the trial [5] - One patient with stage 4 BRAF-mutated melanoma showed a tumor volume reduction of -14.9% and has maintained stable disease for over 5 months [1][5] - All treatment-related adverse events were grade 1 or 2, with no known MEK inhibitor class-related adverse events observed [3] Group 3: Pharmacokinetics - Preliminary PK analysis indicates a linear PK profile with an estimated half-life exceeding 60 hours, and sufficient exposures for target engagement were achieved [4] - The peak to trough ratio was below 2 at steady state across all dose levels, supporting the potential for effective treatment [4] Group 4: Future Outlook - The CEO of Pasithea highlighted the potential of PAS-004 as a best-in-class MEK inhibitor, emphasizing its high selectivity and sustained pathway suppression, which may benefit both monotherapy and combination therapy [6] - The company is also conducting a Phase 1/1b clinical trial for PAS-004 in adult patients with neurofibromatosis type 1-associated plexiform neurofibromas [7]

Core Insights - Pasithea Therapeutics Corp. has initiated a Phase 1/1b clinical trial for PAS-004, a macrocyclic MEK inhibitor, targeting adult patients with neurofibromatosis type 1 (NF1) and symptomatic plexiform neurofibromas, with the first patient expected to be dosed in Q2 2025 [1][4] Group 1: Clinical Trial Details - The trial aims to evaluate safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary efficacy of PAS-004 in adult NF1 patients [1][5] - The first clinical trial site is located at the Royal North Shore Hospital in Sydney, Australia, with additional sites planned in Australia, South Korea, and the United States [2][6] - The study will be conducted in two parts, with Part A focusing on dose exploration and Part B on determining the recommended phase 2 dose (RP2D) [8][9] Group 2: Financial and Operational Aspects - Pasithea has selected Novotech (Australia) Pty Limited as its clinical research organization (CRO) for the trial and anticipates eligibility for an Australian R&D Tax Incentive, which could provide a cash refund of up to 48.5% of eligible trial costs [3][6] - The company is funded to produce initial interim patient data in NF1 following recent financing activities, including the exercise of certain warrants [4] Group 3: Expert Commentary - Dr. Rebecca Brown, a member of Pasithea's Scientific Advisory Board, expressed optimism about the safety profile of PAS-004 based on previous data from advanced cancer patients and highlighted the importance of patient compliance due to the once-daily dosing regimen [4] - Dr. Tiago Reis Marques, CEO of Pasithea, emphasized the significance of this trial as a milestone for both the company and patients with NF1-related plexiform neurofibromas [4]

Pasithea Therapeutics Corp. KTTA is trading higher in the premarket session on Tuesday with a session volume of 22.14 million compared to the average volume of 2.81 million as per data from Benzinga Pro. The clinical-stage biotechnology company released interim pharmacodynamic (PD) data from its ongoing Phase 1 trial of PAS-004 in advanced cancer patients. The data includes results from cohorts 3 and 4A, evaluating 8mg and 15mg capsules, and cohort 4B evaluating 4mg tablets. The data demonstrates strong tar ...

Core Insights - Pasithea Therapeutics Corp. announced positive interim pharmacodynamic data from its Phase 1 trial of PAS-004, a macrocyclic MEK inhibitor targeting neurofibromatosis type 1 and other MAPK pathway-driven cancers [1][5] - The trial demonstrated up to 91% inhibition of pERK, confirming substantial target engagement and a favorable pharmacological profile [1][3] - One patient with stage 4 KRAS G12R mutated pancreatic cancer showed a tumor volume reduction of -9.8% over 5 months of treatment with PAS-004 [1][4] Pharmacodynamic Data - Inhibition of ERK phosphorylation (pERK) is a recognized biomarker for assessing MEK inhibitor activity, with measurements taken from patients at baseline and day 22 [2] - The results indicated robust pERK inhibition, with reductions of up to 91% at the 8mg dose level, aligning with previous PK/PD models [3] Clinical Observations - Preliminary clinical observations showed several patients achieving stable disease and tumor shrinkage while on PAS-004 treatment [4] - The ongoing Phase 1 trial is a multi-center, open-label, dose escalation study evaluating safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy in patients with MAPK pathway-driven advanced solid tumors [5] Company Overview - Pasithea Therapeutics is focused on developing innovative treatments for central nervous system disorders, RASopathies, and MAPK pathway-driven tumors [6]

Core Viewpoint - Pasithea Therapeutics Corp. announced the acceptance of an abstract for a poster presentation at the ASCO Annual Meeting, highlighting the ongoing Phase 1 clinical trial of PAS-004, a macrocyclic MEK inhibitor for treating neurofibromatosis type 1 and other MAPK pathway-driven conditions [1][2]. Group 1: Clinical Trial Details - The ongoing Phase 1 clinical trial is a multi-center, open-label, dose escalation study designed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary efficacy of PAS-004 in patients with MAPK pathway-driven advanced solid tumors [5]. - Updated interim clinical data from cohorts 4A and 4B of the trial has shown clinical activity, target engagement, and a favorable safety profile [3]. Group 2: Presentation Information - The poster presentation will take place on June 2, 2025, from 1:30 PM to 4:30 PM CDT, under the title "Phase 1 dose-escalation study of the safety and pharmacokinetics of PAS-004" [4]. - The full abstract will be available on the ASCO website on May 22, 2025, at 5:00 PM ET [4]. Group 3: Company Overview - Pasithea Therapeutics is focused on the discovery, research, and development of innovative treatments for central nervous system disorders, RASopathies, and MAPK pathway-driven diseases [6].