Pasithea Therapeutics Announces the First Cohort has Completed the Initial Dosing in its Phase 1 Trial Evaluating PAS-004 in RAS, NF1 and RAF Mutated Cancers

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Pasithea Therapeutics Corp. announces the completion of initial dosing for the first cohort in a Phase 1 trial evaluating PAS-004 in RAS, NF1, and RAF mutated cancers. Safety, tolerability, and biomarker data expected in 2H 2024. PAS-004 is a next-generation MEK inhibitor for neurofibromatosis type 1 (NF1) and other indications, showing potential as a best-in-class inhibitor.

Positive

• Completion of initial dosing for the first cohort in Phase 1 trial
• Evaluation of PAS-004 in MAPK pathway driven advanced solid tumors
• Focus on RAS, NF1, and RAF mutated cancers or patients failing BRAF/MEK inhibition
• Expected safety, tolerability, and biomarker data in 2H 2024
• PAS-004 as a next-generation MEK inhibitor for NF1 with extended half-life for better compliance and efficacy
• Plan to initiate a clinical trial in NF1 patients with neurofibromas

Negative

• None.

Oncology Medical Research Analyst

The commencement of the initial dosing of the first cohort in Pasithea Therapeutics' Phase 1 clinical trial for PAS-004 marks the transition of this investigational drug from preclinical to early clinical development. As a MEK inhibitor, PAS-004 targets the MAPK pathway, which is implicated in numerous cancers, making it a significant advance in precision oncology. Initial findings on safety, tolerability, pharmacokinetics and biomarker data are pivotal for understanding the drug's risk profile and potential efficacy. The ambitious target of a 'best-in-class' drug suggests that if PAS-004's unique macrocyclic structure confers advantages over existing MEK inhibitors, such as increased half-life and reduced off-target effects, it could disrupt current treatment paradigms and provide investment upside. However, investors should be aware of the inherent risks of clinical trials, particularly in early phases where many compounds fail to demonstrate sufficient safety or efficacy.

Pharmaceutical Market Research Analyst

The therapeutic landscape for NF1 and MAPK pathway-driven cancers is fiercely competitive and subject to rapid advancements. The claim of PAS-004 as the first macrocyclic MEK inhibitor in human trials positions Pasithea Therapeutics at the forefront of innovation within this drug class. If successful, the extended half-life of PAS-004 could be a game-changer in patient compliance, a factor that significantly influences treatment outcomes. The initiation of subsequent trials in NF1 patients would broaden the potential market for PAS-004, but it's essential for stakeholders to monitor the progression of these trials closely. The indication of planned trials for plexiform and cutaneous neurofibromas, typically challenging to treat, reflects a strategic move to address unmet medical needs, potentially driving investor interest and stock valuation. Nevertheless, the biotech sector's volatility, especially for clinical-stage companies like Pasithea, mandates investor diligence given that stock prices can fluctuate dramatically on positive or negative trial outcomes.

Biotech Financial Analyst

Pasithea Therapeutics' announcement is a meaningful development step for its lead compound, PAS-004. Investors should note the projected timeline for reporting initial data in the second half of 2024, which creates a long-term horizon for any investment thesis surrounding this news. Given that biotech investments are often speculative and hinge on clinical trial outcomes, the long lead time before efficacy and safety data become available is a risk factor to consider. Furthermore, market dynamics, such as competitor advancements and regulatory changes within this period, could influence the investment landscape. The company's stock could see increased volatility as the market anticipates interim results or milestones related to this trial. With the drug's novelty and the challenge of NF1, the potential for positive data could lead to significant upside, while negative data could inversely impact the company's valuation.

– Initial safety, tolerability and biomarker data expected to be reported in 2H 2024 –

SOUTH SAN FRANCISCO, Calif. and MIAMI, Fla., April 24, 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 indications, today announced the first cohort of 3 patients have commenced dosing. PAS-004 is being evaluated in a Phase 1 multicenter open label clinical trial (NCT06299839) 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.

“Completion of the initial dosing of the first cohort of 3 subjects is a significant milestone in Pasithea’s mission towards developing PAS-004 as a potential best-in-class next-generation MEK inhibitor. This Phase 1 study is designed to provide key insights into the safety, tolerability, pharmacokinetics and pERK biomarker data and we look forward to continuing enrollment to higher dose levels. In addition, as part of our clinical development plan, we plan to initiate a clinical trial of PAS-004 in NF1 patients with plexiform and / or cutaneous neurofibromas in the near future” 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 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). Blocking the phosphorylation of ERK 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.

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 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 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 focus of Pasithea Therapeutics Corp.'s Phase 1 trial involving PAS-004?

Pasithea Therapeutics Corp.'s Phase 1 trial evaluates PAS-004 in patients with MAPK pathway driven advanced solid tumors, specifically targeting RAS, NF1, and RAF mutated cancers or patients who have failed BRAF/MEK inhibition.

When is the expected timeline for reporting safety, tolerability, and biomarker data from the trial?

The safety, tolerability, and biomarker data from Pasithea Therapeutics Corp.'s Phase 1 trial evaluating PAS-004 is expected to be reported in the second half of 2024.

What makes PAS-004 unique as a MEK inhibitor in the trial?

PAS-004 is the first macrocyclic MEK inhibitor to enter human clinical trials, offering an extended half-life for better compliance rates and potentially improved efficacy in neurofibromatosis type 1 (NF1) patients.

What are the advantages of macrocycles in comparison to acyclic small molecules?

Macrocycles like PAS-004 exhibit stronger binding, better solubility, longer half-life, increased selectivity, and fewer off-target effects compared to acyclic small molecules.

Who is the Chief Executive Officer of Pasithea Therapeutics Corp.?

Dr. Tiago Reis Marques is the Chief Executive Officer of Pasithea Therapeutics Corp.