Pasithea Therapeutics Announces Opening of European Clinical Trial Sites and Completes Initial Dosing of Cohort 4

Rhea-AI Summary

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.

Positive

• Expansion of clinical trial sites to Eastern Europe, increasing patient recruitment potential
• Successful completion of initial dosing in Cohort 4A
• Active recruitment across seven total clinical sites

Negative

• None.

Insights

Clinical Trial Expert

The expansion of clinical trial sites into Eastern Europe and completion of Cohort 4A dosing represents a strategic development in Pasithea's Phase 1 trial of PAS-004. The addition of three sites in Romania and Bulgaria alongside four U.S. locations effectively doubles the trial's geographical reach, potentially accelerating patient recruitment - particularly important for rare conditions like NF1.

The 3+3 dose escalation design being employed is the gold standard for Phase 1 oncology trials, allowing for careful safety monitoring while advancing through different dose levels. The completion of initial dosing in Cohort 4A at 15mg capsule form, while simultaneously recruiting for Cohort 4B with 4mg tablet formulation, suggests the trial is progressing as planned.

The focus on MAPK pathway-driven tumors with specific mutations (RAS, NF1, RAF) and patients who failed first-generation MEK inhibitors is particularly noteworthy. This targeted approach, combined with the expanded geographical reach, positions the trial to gather more comprehensive data on PAS-004's potential efficacy across diverse patient populations.

Biotech Investment Analyst

For a micro-cap biotech with a market cap of just $3.3M, this development carries strategic significance. The expansion into Eastern European sites through Arensia partnership is a cost-effective approach, as clinical trials in these regions typically have lower operational costs while maintaining high-quality standards. This could help extend Pasithea's cash runway - a critical consideration for small biotechs.

The planned interim data readout in Q1 2025 from Cohorts 4A and 4B will be a key catalyst. The market will particularly focus on safety data and preliminary efficacy signals, as positive results could validate PAS-004's potential as a next-generation MEK inhibitor. The fact that they're testing both capsule and tablet formulations simultaneously suggests preparation for eventual commercialization considerations.

For retail investors, it's important to understand that while this progress is positive, Phase 1 trials primarily focus on safety rather than efficacy. The true value inflection points would likely come with later-stage trials showing efficacy data.

-- Interim data from Cohort 4 expected Q1 2025 --

MIAMI, Jan. 14, 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 cancer indications, today announced it has opened three clinical trial sites in Eastern Europe. These sites in Romania and Bulgaria are actively recruiting patients along with the four open sites in the United States, for Pasithea’s PAS-004 Phase 1 trial.

In Eastern Europe, Pasithea is working with Arensia Exploratory Medicine, Institute of Oncology Bucharest, Arensia Exploratory Medicine, Institute of Oncology Cluj-Napoca, and Arensia Exploratory Medicine, Multiprofile Hospital for Active Treatment Sveta Sofia- EOOD.

In addition, Pasithea has completed initial dosing of three patients in Cohort 4A (15mg capsule). Patient recruitment for Cohort 4B is ongoing (4mg tablet). The Company plans to present interim safety and pharmacokinetic (PK) data from Cohorts 4A and 4B in Q1 2025.

Dr. Tiago Reis Marques, Chief Executive Officer of Pasithea stated, “We are pleased to be working with Arensia in Eastern Europe, allowing PAS-004 to be tested in patients with tumor types more sensitive to single agent MEK treatment or patients who have previously failed first-generation MEK inhibitors.”

The ongoing Phase 1 clinical trial is a multi-center, open-label, dose-escalation 3+3 study design to evaluate the safety, tolerability, pharmacokinetic (PK), pharmacodynamic (PD), and preliminary efficacy of PAS-004 in patients with MAPK pathway-driven advanced solid tumors with a documented RAS, NF1 or RAF mutation or patients who have failed BRAF/MEK inhibition (NCT06299839).

About Pasithea Therapeutics Corp.

Pasithea is a biotechnology company focused on the discovery, research and development of innovative treatments for central nervous system (CNS) disorders and RASopathies. With an experienced team of experts in the fields of neuroscience, translational medicine, and drug development, Pasithea is developing new molecular entities for the treatment of neurological disorders, including Neurofibromatosis type 1 (NF1), Solid Tumors, and Amyotrophic Lateral Sclerosis (ALS).

Forward Looking Statements

This press release contains statements that constitute “forward-looking statements” made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements include statements regarding the Company’s ongoing Phase 1 clinical trial and the safety, tolerability, pharmacokinetic (PK), pharmacodynamics (PD) and preliminary efficacy of PAS-004, as well as all other statements, other than statements of historical fact, regarding the Company’s current views and assumptions with respect to future events regarding its business, as well as other statements with respect to the Company’s plans, assumptions, expectations, beliefs and objectives, the success of the Company’s current and future business strategies, product development, preclinical studies, clinical studies, clinical and regulatory timelines, market opportunity, competitive position, business strategies, potential growth opportunities and other statements that are predictive in nature. Forward-looking statements are subject to numerous conditions, many of which are beyond the control of the Company. While the Company believes these forward-looking statements are reasonable, undue reliance should not be placed on any such forward-looking statements, which are based on information available to the Company on the date of this release. These forward-looking statements are based upon current estimates and assumptions and are subject to various risks and uncertainties, including risks that future clinical trial results may not match results observed to date, may be negative or ambiguous, or may not reach the level of statistical significance required for regulatory approval, as well as other factors set forth in the Company’s most recent Annual Report on Form 10-K, Quarterly Report on Form 10-Q and other filings made with the U.S. Securities and Exchange Commission (SEC). Thus, actual results could be materially different. The Company undertakes no obligation to update these statements whether as a result of new information, future events or otherwise, after the date of this release, except as required by law.

Pasithea Therapeutics Contact

Patrick Gaynes
Corporate Communications
pgaynes@pasithea.com

FAQ

When will Pasithea (KTTA) release interim data for PAS-004 Cohorts 4A and 4B?

Pasithea Therapeutics plans to present interim safety and pharmacokinetic (PK) data from Cohorts 4A and 4B in Q1 2025.

What is the dosing difference between KTTA's PAS-004 Cohort 4A and 4B?

Cohort 4A uses a 15mg capsule formulation, while Cohort 4B uses a 4mg tablet formulation.

How many clinical trial sites does KTTA now have for its PAS-004 study?

KTTA has a total of seven clinical trial sites: four in the United States and three new sites in Eastern Europe (Romania and Bulgaria).

What type of patients is KTTA targeting in its PAS-004 Phase 1 trial?

The trial targets patients with MAPK pathway-driven advanced solid tumors with documented RAS, NF1 or RAF mutation, or patients who have failed BRAF/MEK inhibition.