Pasithea Therapeutics Announces Completion of Enrollment and Initial Dosing of Cohort 2 following Positive Safety Review Committee (SRC) Recommendation for PAS-004 in Ongoing Phase 1 Clinical Trial
Pasithea Therapeutics has completed enrollment and initial dosing for the second cohort in its Phase 1 clinical trial of PAS-004, a macrocyclic MEK inhibitor aimed to treat neurofibromatosis type 1 (NF1) and other conditions. The Safety Review Committee (SRC) recommended escalating to the next dose level (4mg) after a positive safety review of the first dose cohort (2mg), which showed no dose-limiting toxicities or clinically relevant adverse events. The trial, involving patients with advanced solid tumors driven by MAPK pathway mutations, aims to assess the safety, tolerability, and pharmacokinetics (PK) of PAS-004. Initial safety and PK data are expected by Q3 2024.
- Completed enrollment and initial dosing for the second cohort.
- SRC recommended dose escalation to 4mg after positive safety review.
- No dose-limiting toxicities or clinically relevant adverse events in the first cohort.
- Trial is on track for initial safety and PK data release in Q3 2024.
- to results from only three patients in the first cohort, which might not be statistically significant.
- Future results are still pending and uncertain, affecting investor confidence.
Insights
The progression of Pasithea Therapeutics' clinical trial for PAS-004 is a noteworthy development, especially given the company’s focus on treating neurofibromatosis type 1 (NF1) and other MAPK pathway-driven advanced solid tumors. The absence of dose-limiting toxicities (DLTs) and clinically relevant treatment-emergent adverse events at the 2mg dose level is a positive indicator of the drug’s potential safety profile. This is critical, as adverse events can often derail the development of promising therapeutics. The successful completion of enrollment in the second cohort is another positive sign, suggesting strong interest and rapid patient recruitment, which can accelerate the clinical trial timeline.
For retail investors, this news is encouraging as it signals progress without significant safety concerns, which can often lead to increased investor confidence and potential stock price appreciation in the short term. However, it’s important to remain cautious as the trial is still in its early phases and efficacy data will be important in determining the drug’s future potential. The upcoming interim safety and pharmacokinetic (PK) data release in Q3 2024 will provide more concrete insights into the drug’s performance, which will be a vital milestone.
From a clinical research perspective, the recommendation by the independent Safety Review Committee (SRC) to escalate to the next dose level without modifications is a significant milestone. It not only validates the initial safety profile of PAS-004 but also supports the continuation of the trial without delays, which is essential for maintaining momentum and investor interest. The primary objective of assessing safety and tolerability in a dose-escalation study is fundamental in early-phase trials to establish a baseline for the maximum tolerated dose (MTD) and to identify any potential adverse events early on.
For investors, the structured approach of the trial, with clear primary and secondary objectives, demonstrates Pasithea’s commitment to thorough and rigorous clinical evaluation. The focus on pharmacokinetics (PK) and pharmacodynamics (PD) parameters provides a deeper understanding of the drug’s mechanism of action and its behavior within the body, which are critical factors for future regulatory approval and market success. The strategic timeline projecting initial data release in Q3 2024 aligns well with market expectations for incremental updates, potentially bolstering investor confidence as the trial progresses.
The information around Pasithea Therapeutics' Phase 1 clinical trial for PAS-004 holds significant implications for the company’s market position and potential future revenue streams. Neurofibromatosis type 1 (NF1) and other MAPK pathway-driven advanced solid tumors represent substantial unmet medical needs, with currently limited treatment options. PAS-004, as a next-generation macrocyclic MEK inhibitor, could position Pasithea favorably within the oncology market if it proves to be effective and safe through subsequent trial phases.
For retail investors, understanding the market dynamics and potential competitive landscape is crucial. The successful development of PAS-004 could potentially lead to a first-mover advantage in treating NF1, offering significant revenue opportunities. Additionally, the positive safety recommendations and rapid progression in the trial could create upward momentum for the stock, although long-term success will hinge on efficacy results and eventual market adoption. Investors should monitor upcoming data releases closely, as these will be critical in assessing the commercial viability of PAS-004.
-- On track for initial interim safety and PK data release in Q3 2024 --
MIAMI, June 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 indications, announced today that an independent Safety Review Committee (SRC) has completed its safety review of data from the first dose cohort (2mg) treated in the ongoing Phase 1 clinical trial (NCT06299839) 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.
Based on these findings, the SRC recommended that the trial escalate to the next dose level (4mg) without modifications. This recommendation was based on the absence of any dose limiting toxicities (DLT’s) or clinically relevant treatment-emergent adverse events in the initial cohort of 3 patients. The Company has now completed enrollment and initial dosing of 3 patients in the second cohort.
Dr. Tiago Reis Marques, Chief Executive Officer of Pasithea stated, "We are pleased to have rapidly enrolled and completed first dosing of the participants in the second cohort following the SRC's positive recommendation to advance to 4mg of PAS-004. We look forward to continuing to develop PAS-004 as a potential treatment for solid tumors as well as cutaneous and plexiform neurofibromas in NF1 patients. We remain on track to present our initial safety and pharmacokinetic (PK) data in the third quarter of 2024."
The Phase 1 trial is a multicenter, open-label, dose escalation study evaluating the safety, tolerability, and pharmacokinetics (PK) and pharmacodynamics (PD) 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 primary objective of the study is to assess the safety and tolerability of PAS-004, with secondary objectives including PK and PD parameters, an evaluation of the preliminary anticancer activity (efficacy) of PAS-004 and defining the preliminary recommended Phase 2 dose(s).
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 and clinical trials, clinical and regulatory timelines, market opportunity, competitive position, 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 (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.
Contact
Patrick Gaynes
Corporate Communications
pgaynes@pasithea.com
FAQ
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