Pasithea Therapeutics Announces FDA Acceptance of IND Application to Evaluate PAS-004 in Advanced Cancer Patients
Pasithea Therapeutics Corp. (NASDAQ: KTTA) announced the FDA clearance to evaluate PAS-004, a macrocyclic MEK inhibitor, in patients with MAPK pathway driven advanced solid tumors. The phase 1 dose escalation study is expected to begin in Q1 2024, with an initial readout anticipated as early as Q3 2024.
Macrocyclic MEK inhibitors like PAS-004 represent a novel class of therapeutics in oncology with the potential to address treatment-resistant MAPK pathway-driven cancers. The MAPK pathway is integral to cell division and survival and its dysregulation is implicated in various forms of cancer. PAS-004's targeting of this pathway, specifically in patients with RAS, RAF, or NF1 mutations, or those who have not responded to previous BRAF/MEK inhibition, could offer a new avenue for treatment where other therapies have failed.
The clinical development of PAS-004, particularly its monotherapy evaluation, is significant. The safety, tolerability and anti-tumor efficacy data from the Phase 1 trial will be critical in determining its potential as a 'best-in-class' treatment. If PAS-004 demonstrates a more favorable dosing profile and improved clinical responses, it could substantially impact patient management and outcomes. The extension of research to Neurofibromatosis type 1 patients further underscores the potential versatility and impact of this compound in oncology.
The FDA's IND clearance for PAS-004 is a pivotal step for Pasithea Therapeutics, transitioning it into a clinical-stage company. This transition often results in increased scrutiny from investors and stakeholders, as clinical outcomes become a primary driver of valuation. The mention of Eastern Europe as a location for clinical trials suggests a strategic approach to trial execution, possibly due to regulatory, cost, or patient population considerations.
From a development perspective, the pharmacokinetics and pharmacodynamics data will be essential to understand how PAS-004 behaves in the human body and its mechanism of action at a molecular level. The preliminary readout expected in Q3 2024 will provide early indications of efficacy and safety, which are crucial for further investment and development decisions. For stakeholders, the trial's progress and results will be a significant determinant of Pasithea's future trajectory and stock performance.
The oncology market is highly competitive, with numerous companies seeking to develop innovative treatments for cancer. Pasithea's entry into this space with a first-in-class macrocyclic MEK inhibitor positions it within a niche segment of the market that could have a competitive edge. The oral administration and potential for less frequent dosing of PAS-004 may improve patient adherence and quality of life, which are important factors in treatment success and market acceptance.
Investors will monitor the development of PAS-004 closely, as early clinical data will inform the drug's commercial potential and Pasithea's valuation. A successful Phase 1 trial could lead to partnerships, licensing deals, or increased funding for further development. Conversely, any setbacks could have a negative impact on investor confidence. It's crucial to consider the long development timelines and high costs associated with oncology drug development when evaluating the potential financial implications of PAS-004's clinical trials.
01/02/2024 - 08:35 AM
-- PAS-004 is the first macrocyclic MEK inhibitor to enter human clinical trials --
-- Phase 1 dose escalation study in patients with MAPK pathway driven advanced solid tumors to begin in Q1 2024 –
-- Initial readout expected as early as Q3 2024 –
SOUTH SAN FRANCISCO, Calif. and MIAMI, Jan. 02, 2024 (GLOBE NEWSWIRE) -- Pasithea Therapeutics Corp.
The objectives of the dose escalation study are to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics as well as anti-tumor responses of PAS-004 as monotherapy in up to 36 advanced cancer patients with preliminary early data expected as early as Q3 2024.
“Receiving a study may proceed notification from the US FDA is a significant milestone in Pasithea’s maturation into a clinical stage company developing PAS-004 as a potential best-in-class next generation MEK inhibitor and demonstrates our ability to execute on our objectives,” said Dr. Tiago Reis Marques, Chief Executive Officer of Pasithea. “We believe PAS-004 has the potential to improve clinical responses in cancer patients as a monotherapy as well as provide a more tolerable and better dosing profile. After we have established a preliminary recommended phase 2 dose, we will use this information to bridge to dosing for Neurofibromatosis type 1 patients. We look forward to working with our clinical partners to start this study in the United States and Eastern Europe shortly.”
Administered orally, PAS-004 is expected to be an once day or less frequent dose which may provide better compliance rates as well as superior efficacy. PAS-004 is the first macrocyclic MEK inhibitor to enter human clinical trials. Macrocycles exhibit unique drug-like profiles because of their cyclic structure, potentially improving bioavailability, binding affinity, and overall pharmacokinetics in comparison to acyclic counterparts.
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 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 factors set forth in the Company’s most recent Form 10-K, Form 10-Q and 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 Gaynespgaynes@pasithea.com
What is the significance of the FDA clearance announced by Pasithea Therapeutics Corp. (KTTA)?
The FDA clearance allows Pasithea to evaluate PAS-004, a macrocyclic MEK inhibitor, in patients with MAPK pathway driven advanced solid tumors, marking a significant milestone in the company's development as a clinical stage company.
What are the objectives of the phase 1 dose escalation study for PAS-004?
The objectives of the study are to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and anti-tumor responses of PAS-004 as monotherapy in up to 36 advanced cancer patients, with preliminary early data expected as early as Q3 2024.
What are the potential benefits of PAS-004 as a monotherapy for cancer patients?
PAS-004 has the potential to improve clinical responses in cancer patients as a monotherapy, potentially providing a more tolerable and better dosing profile. It is also expected to be administered orally, potentially offering better compliance rates and superior efficacy.
Why is PAS-004 considered significant as the first macrocyclic MEK inhibitor to enter human clinical trials?
Macrocycles exhibit unique drug-like profiles due to their cyclic structure, potentially improving bioavailability, binding affinity, and overall pharmacokinetics in comparison to acyclic counterparts, making PAS-004 a significant advancement in MEK inhibitor development.
