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Pasithea Therapeutics (NASDAQ: KTTA) has reached a significant milestone in its Phase 1 clinical trial of PAS-004, a next-generation macrocyclic MEK inhibitor. The company has successfully completed enrollment and initial dosing of three subjects in Cohort 6, administering 30 mg capsules of PAS-004.
The ongoing trial is designed as a multi-center, open-label, dose escalation 3+3 study, focusing on patients with MAPK pathway driven advanced solid tumors. The study specifically targets patients with documented RAS, NF1, or RAF mutations, or those who have not responded to BRAF/MEK inhibition.
CEO Dr. Tiago Reis Marques expressed satisfaction with the rapid recruitment and enrollment pace, projecting complete trial enrollment by the end of 2025. The study aims to evaluate multiple aspects of PAS-004, including:
- Safety and tolerability
- Pharmacokinetics (PK)
- Pharmacodynamics (PD)
- Preliminary efficacy
Pasithea Therapeutics (NASDAQ: KTTA) has announced that it will present updated interim clinical data from its ongoing Phase 1 trial of PAS-004, a next-generation macrocyclic MEK inhibitor, at the 2025 ASCO Annual Meeting in Chicago. The presentation will take place on June 2, 2025, from 1:30 – 4:30 PM CDT.
The trial focuses on patients with MAPK pathway driven advanced solid tumors and has shown promising results through cohorts 4A and 4B, demonstrating clinical activity, target engagement, and a favorable safety profile. PAS-004 is being developed for treating neurofibromatosis type 1 (NF1) and other MAPK pathway driven indications.
The Phase 1 clinical trial (NCT06299839) is designed as a multi-center, open-label, dose escalation 3+3 study, evaluating safety, tolerability, pharmacokinetic, pharmacodynamic, and preliminary efficacy in patients with documented RAS, NF1 or RAF mutations, or those who have failed BRAF/MEK inhibition.
Pasithea Therapeutics (NASDAQ: KTTA) announced positive progress in its Phase 1 clinical trial of PAS-004, a next-generation macrocyclic MEK inhibitor for treating neurofibromatosis type 1 (NF1) and other cancers. The Safety Review Committee recommended advancing to Cohort 6 with a 30mg capsule dose following review of Cohort 5 data.
Key highlights include:
- No dose-limiting toxicities (DLTs) observed across 19 patients
- Zero instances of rash reported during the DLT period
- Strong enrollment demand with Cohort 6 patients already identified
The trial (NCT06299839) is a multi-center, open-label, dose escalation study evaluating PAS-004's safety, tolerability, and preliminary efficacy in patients with MAPK pathway driven advanced solid tumors. The company plans to release additional safety, pharmacokinetic, and pharmacodynamic data in the coming weeks.
Pasithea Therapeutics (NASDAQ: KTTA) has announced its participation in the upcoming 2025 CAGLA NeauxCancer Conference, a leading global oncology forum scheduled for March 27-29, 2025, in New Orleans.
The company's Vice President of Business Development, Mathew Lazarus, will present on March 28 at 11:00 AM CDT at The Roosevelt Hotel. His presentation will focus on PAS-004, the company's next-generation macrocyclic MEK inhibitor being developed for neurofibromatosis type 1 (NF1) and other cancer indications.
The presentation will include interim data from their ongoing Phase 1 study, covering safety, tolerability, and pharmacokinetic (PK) results in advanced cancer patients with MAPK pathway-driven tumors. Lazarus will also discuss Pasithea's progress in clinical development and their strategy to revolutionize cancer and NF1 treatment.
Pasithea Therapeutics (NASDAQ: KTTA) announced positive safety review recommendations for its Phase 1 clinical trial of PAS-004, advancing to cohort 5 with a 22mg capsule dose. The trial, evaluating a next-generation macrocyclic MEK inhibitor for neurofibromatosis type 1 (NF1) and other cancers, showed no dose-limiting toxicities in cohort 4A (15mg capsule) patients.
Notably, none of the 14 patients treated with PAS-004 (12 capsule, 2 tablet formulations) experienced rash, a common side effect with competitor MEK inhibitors that often leads to treatment discontinuation. The drug demonstrates a half-life exceeding 60 hours and substantial exposure levels. The ongoing multi-center, open-label study (NCT06299839) evaluates safety, tolerability, and preliminary efficacy in patients with MAPK pathway-driven advanced solid tumors with RAS, NF1, or RAF mutations.
Pasithea Therapeutics (NASDAQ: KTTA) has expanded its Phase 1 clinical trial for PAS-004, a next-generation macrocyclic MEK inhibitor, by opening three new sites in Eastern Europe. The trial now includes locations in Romania and Bulgaria, operating alongside four existing U.S. sites. The company has completed initial dosing of three patients in Cohort 4A (15mg capsule) and is currently recruiting for Cohort 4B (4mg tablet).
The ongoing trial is a multi-center, open-label, dose-escalation study evaluating PAS-004's safety, tolerability, and preliminary efficacy in patients with MAPK pathway-driven advanced solid tumors. The company expects to present interim safety and pharmacokinetic data from Cohorts 4A and 4B in Q1 2025.
Pasithea Therapeutics (NASDAQ: KTTA) announced positive safety results from its Phase 1 clinical trial of PAS-004, a next-generation macrocyclic MEK inhibitor. The Safety Review Committee recommended advancing to cohort 4 with a 15mg capsule dose, following no dose-limiting toxicities in the first 9 patients. Notably, no rash was observed, which is a common adverse event with competitor MEK inhibitors. The company will add cohort 4b to test a commercial formulation. PAS-004 demonstrates advantages over first-generation MEK inhibitors, including a longer half-life of 70 hours enabling once-daily dosing, and consistent plasma levels at steady-state.
Pasithea Therapeutics Corp. (NASDAQ: KTTA) has announced a $5 million private placement priced at-the-market under Nasdaq rules. The offering includes the sale of 1,219,513 shares of common stock (or pre-funded warrants) with accompanying Series A and short-term Series B warrants at $4.10 per share. Both warrant series have an exercise price of $3.85 per share, with Series A expiring in 5 years and Series B in 18 months.
The closing is expected around September 30, 2024, subject to customary conditions. H.C. Wainwright & Co. is the exclusive placement agent. Pasithea plans to use the net proceeds for working capital and general corporate purposes. The securities are offered under Section 4(a)(2) of the Securities Act and/or Regulation D and have not been registered, limiting their sale in the United States.
Pasithea Therapeutics (NASDAQ: KTTA) announced positive initial data from its Phase 1 clinical trial of PAS-004, a next-generation macrocyclic MEK inhibitor, for advanced cancer treatment. The trial, conducted at four U.S. sites, showed promising results in safety, tolerability, pharmacokinetics (PK), and preliminary efficacy.
Key findings include:
- No treatment-related adverse events or dose-limiting toxicities observed
- Long half-life of ~70 hours, supporting once-daily or less frequent oral dosing
- Constant target inhibition while avoiding peak plasma toxicities
- A patient with stage 3 colon cancer achieved prolonged stable disease
The company believes PAS-004 demonstrates a differentiated MEK inhibitor profile, potentially outperforming current inhibitors in safety, dosing frequency, and efficacy for treating neurofibromatosis type 1 (NF1) and other cancer indications.