Pasithea Therapeutics Announces Opening of Enrollment in the U.S. for its Phase 1 Trial of PAS-004

Rhea-AI Summary

Pasithea Therapeutics Corp. (NASDAQ: KTTA) announced the activation of four U.S. clinical trial sites for Phase 1 trial of PAS-004, a next-generation MEK inhibitor for treating NF1 and other cancer indications. The company plans to open three more sites in Eastern Europe. Preliminary interim data is expected in 2H 2024.

Insights

Medical Research Analyst

The commencement of Phase 1 clinical trials for PAS-004 introduces a significant development within the biotechnology sector, particularly for the treatment of neurofibromatosis type 1 (NF1) and other cancer indications. The selection of multiple sites across the U.S. and the anticipated expansion into Eastern Europe reflects a robust and geographically diversified approach to patient recruitment and data collection, which is critical for assessing drug safety and efficacy across different populations.

The focus on MAPK pathway-driven advanced solid tumors positions PAS-004 as a potential key player in the oncology market, where targeted therapies are increasingly sought after. PAS-004's macrocyclic structure could offer advantages over traditional small molecule inhibitors, such as improved pharmacokinetics and pharmacodynamics, which might translate to better patient outcomes and market competitiveness.

Investors should note the projected timeline for preliminary interim data in the second half of 2024, as this will provide a critical inflection point for evaluating the drug's future potential and could have significant influence on the company's stock valuation.

Oncology Doctor

The activation of clinical trial sites for a Phase 1 study of a MEK inhibitor like PAS-004 is a noteworthy event in the field of oncology. MEK inhibitors are a class of drugs that target the MAPK/ERK pathway, which is often dysregulated in various cancers and their role in managing tumors with RAS, NF1, or RAF mutations is of particular interest. The choice of Novotech as the CRO and collaboration with NEXT Oncology enhances the credibility of the trial, given the expertise these entities bring to the table.

For patients with NF1, a condition that can lead to benign and malignant tumors, the development of PAS-004 could represent a significant advancement in treatment options. The drug's macrocyclic nature suggests potential for enhanced efficacy and safety profiles, which are crucial factors in the treatment of pediatric and adult patients alike.

Pharmacologist

The pharmacological properties of PAS-004, particularly as a macrocyclic MEK inhibitor, are of interest. Macrocycles typically offer several advantages over acyclic compounds, including stronger binding affinities and better pharmacokinetic profiles, which may lead to more effective and safer therapeutic options. The extended half-life of PAS-004 could result in less frequent dosing requirements, potentially improving patient compliance and overall treatment success.

Understanding the pharmacokinetics (PK) and pharmacodynamics (PD) of PAS-004 is essential, as these will inform dosing strategies and predict therapeutic outcomes. The Phase 1 trial's goal to establish safety and PK data before progressing to Phase 2 trials is a standard approach that ensures a thorough evaluation of the drug's behavior in the human body before wider application.

-- Activation of four U.S. sites for Phase 1 clinical trial of PAS-004 to evaluate safety, dose, key biomarker data and preliminary efficacy --

-- Plans to open three additional sites in Eastern Europe in the coming months --

-- Preliminary interim data expected in 2H 2024 --

SOUTH SAN FRANCISCO, Calif. and MIAMI, Feb. 13, 2024 (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 the activation of four clinical trial sites in the United States. These U.S. clinical trial sites in Texas and Virginia are now open and actively enrolling patients.

This announcement follows the approval from the U.S. Food and Drug Administration (FDA) of the Investigational New Drug (IND) application for PAS-004, and FDA review of the protocol for the Company’s Phase 1 multicenter, open-label trial 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.

The objective of the Phase 1 study is to assess the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of PAS-004 as well as to evaluate the preliminary anticancer activity (efficacy) of PAS-004 and to define the preliminary recommended Phase 2 dose.

The Company's clinical development plan for PAS-004 following the Phase 1 study is to begin a Phase 2 clinical trial in NF1 pediatric and adult patients as soon as safety and PK are established.

Pasithea has selected Novotech as the clinical research organization (CRO) for the Phase 1 trial and will be collaborating in the U.S. with NEXT Oncology, led by Dr. Anthony Tolcher M.D., along with Dr. Ildefonso Rodriguez M.D., acting as principal investigator for the San Antonio, TX site. There are also three other clinical trial sites in Eastern Europe that are expected to open in the coming months.

“Activating our four clinical trial sites in the U.S. is a significant milestone in Pasithea’s mission towards developing PAS-004 as a potential best-in-class next-generation MEK inhibitor. We recognize the significant unmet needs and limited treatment options for patients with MAPK pathway-driven advanced solid tumors as well as NF1. We are ready to screen and enroll subjects in the coming month and look forward to gaining insight into the safety, tolerability and initial efficacy of PAS-004.” said Dr. Tiago Reis Marques, Chief Executive Officer of Pasithea.

PAS-004 is the first macrocyclic MEK inhibitor to enter human clinical trials, with an expected extended half-life in humans which may provide better compliance rates as well as improved efficacy in NF1. Macrocycles are known to exhibit stronger binding, better solubility and longer half-life with more selectivity and less off target effect as compared to acyclic small molecules.

About PAS-004

PAS-004 is a small molecule allosteric inhibitor of MEK 1/2, which are dual-specificity protein kinases, in the MAPK signaling pathway. The MAPK pathway has been implicated in a variety of diseases, as it functions to drive cell proliferation, differentiation, survival and a variety of other cellular functions that, when abnormally activated, are critical for the formation and progression of tumors, fibrosis and other diseases. MEK inhibitors block phosphorylation (activation) of extracellular signal-regulated kinases (ERK), which can lead to cell death and inhibition of tumor growth. Existing FDA approved MEK inhibitors are marketed for a range of diseases, including certain cancers and neurofibromatosis type 1 (NF1). We believe these MEK inhibitors suffer from certain limitations, including known toxicities. Unlike current FDA approved MEK inhibitors, PAS-004 is macrocyclic, which we believe may lead to improved pharmacokinetic and safety (tolerability) profiles. Cyclization offers rigidity for stronger binding with drug target receptors. PAS-004 was designed to provide a longer half-life with what we believe is a better therapeutic window. Further, we believe the potency and safety profile that PAS-004 has demonstrated in preclinical studies may also lead to stronger and more durable response rates and efficacy, as well as better dosing schedules. PAS-004 has been tested in a range of mouse models of various diseases and has completed preclinical testing and animal toxicology studies. Additionally, PAS-004 has received orphan-drug designation from the FDA for the treatment of NF1, which may provide seven years of marketing exclusivity upon approval of an NDA.

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 other diseases. 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 all 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 and 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 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. Thus, actual results could be materially different. The Company undertakes no obligation to update these forward-looking 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

What is the purpose of the Phase 1 clinical trial for PAS-004?

The Phase 1 trial aims to assess safety, dose, key biomarker data, preliminary efficacy, pharmacokinetics, and pharmacodynamics of PAS-004.

What is the expected timeline for preliminary interim data from the trial?

Preliminary interim data is expected in the second half of 2024.

Who is the clinical research organization (CRO) for the Phase 1 trial?

Novotech has been selected as the CRO for the Phase 1 trial.

What makes PAS-004 unique in terms of MEK inhibitors?

PAS-004 is the first macrocyclic MEK inhibitor to enter human clinical trials, offering an expected extended half-life in humans for better compliance rates and efficacy in NF1.

What are the benefits of macrocycles compared to acyclic small molecules in terms of drug properties?

Macrocycles exhibit stronger binding, better solubility, longer half-life, more selectivity, and fewer off-target effects compared to acyclic small molecules.