Pasithea Therapeutics Announces Positive Safety Review Committee (SRC) Recommendation from its ongoing Phase 1 Clinical Trial of PAS-004 in Advanced Cancer
Pasithea Therapeutics (NASDAQ: KTTA) announced positive safety review recommendations for its Phase 1 clinical trial of PAS-004, advancing to cohort 5 with a 22mg capsule dose. The trial, evaluating a next-generation macrocyclic MEK inhibitor for neurofibromatosis type 1 (NF1) and other cancers, showed no dose-limiting toxicities in cohort 4A (15mg capsule) patients.
Notably, none of the 14 patients treated with PAS-004 (12 capsule, 2 tablet formulations) experienced rash, a common side effect with competitor MEK inhibitors that often leads to treatment discontinuation. The drug demonstrates a half-life exceeding 60 hours and substantial exposure levels. The ongoing multi-center, open-label study (NCT06299839) evaluates safety, tolerability, and preliminary efficacy in patients with MAPK pathway-driven advanced solid tumors with RAS, NF1, or RAF mutations.
Pasithea Therapeutics (NASDAQ: KTTA) ha annunciato raccomandazioni positive per la revisione della sicurezza nel suo studio clinico di Fase 1 relativo a PAS-004, avanzando al coorte 5 con una dose di 22 mg in forma di capsula. Lo studio, che valuta un inibitore MEK macrocyclico di nuova generazione per la neurofibromatosi di tipo 1 (NF1) e altri tumori, non ha evidenziato tossicità limitanti la dose nei pazienti del coorte 4A (capsule da 15 mg).
È importante notare che nessuno dei 14 pazienti trattati con PAS-004 (12 in formulazione a capsula, 2 a compressa) ha manifestato eruzioni cutanee, un effetto collaterale comune con gli inibitori MEK concorrenti che spesso portano all'interruzione del trattamento. Il farmaco presenta un'emivita superiore a 60 ore e livelli di esposizione significativi. Lo studio attualmente in corso, multicentrico e open-label (NCT06299839), valuta la sicurezza, la tollerabilità e l'efficacia preliminare in pazienti con tumori solidi avanzati guidati dalla via MAPK con mutazioni RAS, NF1 o RAF.
Pasithea Therapeutics (NASDAQ: KTTA) anunció recomendaciones positivas para la revisión de seguridad en su ensayo clínico de Fase 1 de PAS-004, avanzando a la cohorte 5 con una dosis de cápsula de 22 mg. El ensayo, que evalúa un inhibidor MEK macro cíclico de nueva generación para la neurofibromatosis tipo 1 (NF1) y otros cánceres, no mostró toxicidades limitantes de dosis en pacientes de la cohorte 4A (cápsula de 15 mg).
Notablemente, ninguno de los 14 pacientes tratados con PAS-004 (12 en formulación de cápsula, 2 en tabletas) experimentó erupciones cutáneas, un efecto secundario común con los inhibidores MEK competidores que a menudo llevan a la interrupción del tratamiento. El fármaco demuestra una vida media que supera las 60 horas y niveles de exposición sustanciales. El estudio en curso, multicéntrico y abierto (NCT06299839), evalúa la seguridad, tolerabilidad y eficacia preliminar en pacientes con tumores sólidos avanzados impulsados por la vía MAPK con mutaciones RAS, NF1 o RAF.
파시테아 테라퓨틱스 (NASDAQ: KTTA)는 PAS-004의 1상 임상시험에 대한 긍정적인 안전성 검토 권고를 발표하며 22mg 캡슐 용량의 코호트 5로 진행한다고 발표했습니다. 이 시험은 신경섬유종증 제1형(NF1) 및 기타 암을 위한 차세대 매크로사이클 MEK 억제제를 평가하며, 코호트 4A(15mg 캡슐) 환자에서 용량 제한 독성이 나타나지 않았습니다.
특히, PAS-004로 치료받은 14명 환자 중 어느 누구도 발진을 경험하지 않았습니다. 발진은 종종 치료 중단으로 이어지는 경쟁사의 MEK 억제제에서 흔히 나타나는 부작용입니다. 이 약물은 60시간을 초과하는 반감기를 가지며 상당한 노출 수준을 보여줍니다. 진행 중인 다기관, 공개 연구(NCT06299839)는 RAS, NF1 또는 RAF 변이가 있는 MAPK 경로에 의해 유도된 진행성 고형 종양 환자에서 안전성, 내약성 및 초기 효능을 평가합니다.
Pasithea Therapeutics (NASDAQ: KTTA) a annoncé des recommandations positives pour la révision de la sécurité de son essai clinique de Phase 1 concernant PAS-004, avançant vers la cohorte 5 avec une dose de 22 mg en capsule. L'essai, qui évalue un inhibiteur MEK macrocyclique de nouvelle génération pour la neurofibromatose de type 1 (NF1) et d'autres cancers, n'a montré aucune toxicité limitante de dose chez les patients de la cohorte 4A (capsule de 15 mg).
Il est notamment à souligner qu'aucun des 14 patients traités avec PAS-004 (12 en forme de capsule, 2 en comprimé) n'a présenté d'éruption cutanée, un effet secondaire courant des inhibiteurs MEK concurrents qui entraîne souvent une interruption du traitement. Le médicament montre une demi-vie dépassant 60 heures et des niveaux d'exposition substantiels. L'étude multicentrique en cours et en ouvert (NCT06299839) évalue la sécurité, la tolérabilité et l'efficacité préliminaire chez des patients ayant des tumeurs solides avancées liées à des mutations RAS, NF1 ou RAF dans la voie MAPK.
Pasithea Therapeutics (NASDAQ: KTTA) gab positive Sicherheitsüberprüfungen für seine Phase-1-Studie zu PAS-004 bekannt und schreitet zur Kohorte 5 mit einer Dosis von 22 mg in Kapselform voran. Die Studie, die einen neuartigen makrozyklischen MEK-Hemmer bei Neurofibromatose Typ 1 (NF1) und anderen Krebsarten bewertet, zeigte in der Kohorte 4A (15 mg Kapsel) keine dosisbegrenzenden Toxizitäten bei den Patienten.
Bemerkenswert ist, dass keiner der 14 Patienten, die mit PAS-004 (12 in Kapsel- und 2 in Tablettenform) behandelt wurden, einen Hautausschlag erlebte, der ein häufiges Nebenwirkung von konkurrierenden MEK-Hemmern ist und oft zu einer Beendigung der Behandlung führt. Das Medikament weist eine Halbwertszeit von über 60 Stunden und erhebliche Expositionslevels auf. Die laufende multizentrische, offene Studie (NCT06299839) bewertet die Sicherheit, Verträglichkeit und vorläufige Wirksamkeit bei Patienten mit fortgeschrittenen soliden Tumoren, die durch Mutationen in den RAS-, NF1- oder RAF-Wegen gefördert werden.
- Phase 1 trial successfully advancing to higher dose (22mg capsule)
- No dose-limiting toxicities observed in current dosing cohort
- No rash side effects reported in any of 14 treated patients
- Drug demonstrates long half-life of over 60 hours
- None.
Insights
The latest safety data from Pasithea's Phase 1 trial of PAS-004 represents a significant milestone in the development of next-generation MEK inhibitors. The trial's progression to the 22mg dose level without any dose-limiting toxicities (DLTs) is particularly noteworthy in the context of cancer drug development.
The most compelling aspect is the complete absence of rash in all 14 treated patients across both capsule and tablet formulations. This is a critical differentiator from existing MEK inhibitors, where rash typically emerges at low doses and forces many patients to discontinue treatment. The clean safety profile, combined with PAS-004's extended half-life of over 60 hours, suggests potential for improved patient compliance and treatment outcomes.
The trial's 3+3 dose escalation design is methodologically robust, requiring three patients at each dose level with an expansion to six patients if any toxicity is observed. This conservative approach provides strong safety validation while efficiently identifying the maximum tolerated dose.
The planned presentation of pharmacokinetic and pharmacodynamic data in Q1 2025 will be important for:
- Validating the drug's exposure levels and target engagement
- Determining optimal dosing strategies
- Supporting the potential expansion into NF1 indications
For investors, this positive safety profile substantially de-risks the clinical development program and strengthens PAS-004's potential positioning in both the NF1 and broader oncology markets. The absence of common MEK inhibitor side effects could translate into significant market advantage if maintained in later-stage trials.
- SRC recommended that the trial escalate to the next dose level of 22mg capsule
- No dose-limiting toxicities (DLT’s) or rash observed to date in either capsule or tablet formulations
MIAMI, Feb. 05, 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 that the external Safety Review Committee recommended that the Company’s Phase 1 clinical trial of PAS-004 in advanced cancer should proceed to cohort 5, 22mg capsule, without modification. This recommendation was based on the review of the safety data from three patients in cohort 4A (15mg capsule) and the absence of any dose limiting toxicities (DLT’s). In addition, no rash has been observed to date in any of the first 14 patients who have been dosed with PAS-004 in either capsule (12 patients) or tablet (2 patients) formulation. Rash is a common adverse event (AE) that is observed at low doses with competitor MEK inhibitors and may lead to the high discontinuation rate in real world practice.
“As we are observing substantial exposure levels of PAS-004, we remain encouraged by the safety profile PAS-004 continues to exhibit,” stated Dr. Tiago Reis Marques, Chief Executive Officer of Pasithea. “With the differentiated profile of PAS-004, we believe it is possible that this highly specific macrocyclic MEK inhibitor with a half life of greater than 60 hours may change the treatment paradigm for patients with NF1 and inoperable plexiform neurofibromas. We are looking forward to presenting updated pharmakokinetic (PK) and pharmacodynamic (PD) data during Q1 2025.”
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
What are the latest Phase 1 trial results for Pasithea's PAS-004 (KTTA)?
How does PAS-004's safety profile compare to other MEK inhibitors?
What is the half-life of Pasithea's PAS-004 drug (KTTA)?
When will Pasithea (KTTA) release updated PK and PD data for PAS-004?
What types of cancer patients are eligible for the PAS-004 Phase 1 trial?
