Pasithea Therapeutics Announces Completion of Enrollment and Initial Dosing of Patients in Cohort 6 from its Phase 1 Trial of PAS-004 in Advanced Cancer Patients
Pasithea Therapeutics (NASDAQ: KTTA) has reached a significant milestone in its Phase 1 clinical trial of PAS-004, a next-generation macrocyclic MEK inhibitor. The company has successfully completed enrollment and initial dosing of three subjects in Cohort 6, administering 30 mg capsules of PAS-004.
The ongoing trial is designed as a multi-center, open-label, dose escalation 3+3 study, focusing on patients with MAPK pathway driven advanced solid tumors. The study specifically targets patients with documented RAS, NF1, or RAF mutations, or those who have not responded to BRAF/MEK inhibition.
CEO Dr. Tiago Reis Marques expressed satisfaction with the rapid recruitment and enrollment pace, projecting complete trial enrollment by the end of 2025. The study aims to evaluate multiple aspects of PAS-004, including:
- Safety and tolerability
- Pharmacokinetics (PK)
- Pharmacodynamics (PD)
- Preliminary efficacy
Pasithea Therapeutics (NASDAQ: KTTA) ha raggiunto un importante traguardo nella sua sperimentazione clinica di Fase 1 di PAS-004, un inibitore macrocillico di nuova generazione del MEK. L'azienda ha completato con successo l'arruolamento e la somministrazione iniziale di tre soggetti nel Gruppo 6, somministrando capsule da 30 mg di PAS-004.
Lo studio in corso è progettato come uno studio multicentrico, in aperto, con schema di incremento di dose 3+3, focalizzato su pazienti con tumori solidi avanzati guidati dalla via MAPK. La ricerca si rivolge specificamente a pazienti con mutazioni documentate di RAS, NF1 o RAF, oppure a coloro che non hanno risposto all'inibizione di BRAF/MEK.
Il CEO, Dr. Tiago Reis Marques, ha espresso soddisfazione per il rapido ritmo di reclutamento e arruolamento, prevedendo il completamento dell'arruolamento entro la fine del 2025. Lo studio mira a valutare diversi aspetti di PAS-004, tra cui:
- Sicurezza e tollerabilità
- Farmacocinetica (PK)
- Farmacodinamica (PD)
- Efficacia preliminare
Pasithea Therapeutics (NASDAQ: KTTA) ha alcanzado un hito importante en su ensayo clínico de Fase 1 de PAS-004, un inhibidor macrocilíndrico de MEK de próxima generación. La empresa ha completado con éxito la inscripción y la dosificación inicial de tres sujetos en el Cohorte 6, administrando cápsulas de 30 mg de PAS-004.
El ensayo en curso está diseñado como un estudio multicéntrico, abierto, con escalada de dosis 3+3, centrado en pacientes con tumores sólidos avanzados impulsados por la vía MAPK. El estudio se dirige específicamente a pacientes con mutaciones documentadas en RAS, NF1 o RAF, o a aquellos que no han respondido a la inhibición de BRAF/MEK.
El CEO, Dr. Tiago Reis Marques, expresó satisfacción por el rápido ritmo de reclutamiento e inscripción, proyectando la finalización del reclutamiento para finales de 2025. El estudio tiene como objetivo evaluar varios aspectos de PAS-004, incluyendo:
- Seguridad y tolerabilidad
- Farmacocinética (PK)
- Farmacodinámica (PD)
- Eficacia preliminar
Pasithea Therapeutics (NASDAQ: KTTA)는 차세대 매크로사이클릭 MEK 억제제인 PAS-004의 1상 임상시험에서 중요한 이정표를 달성했습니다. 회사는 6번째 코호트에서 3명의 피험자 등록과 초기 투약을 성공적으로 완료했으며, PAS-004 30mg 캡슐을 투여했습니다.
진행 중인 임상시험은 다기관, 공개, 3+3 용량 증량 방식으로 설계되었으며, MAPK 경로에 의해 유발된 진행성 고형암 환자를 대상으로 합니다. 연구는 RAS, NF1, RAF 돌연변이가 확인된 환자 또는 BRAF/MEK 억제에 반응하지 않은 환자를 특별히 대상으로 합니다.
CEO인 Dr. Tiago Reis Marques는 빠른 모집 및 등록 속도에 만족감을 표하며, 2025년 말까지 임상시험 등록 완료를 예상하고 있습니다. 본 연구는 PAS-004의 여러 측면을 평가하는 것을 목표로 합니다:
- 안전성 및 내약성
- 약동학 (PK)
- 약력학 (PD)
- 예비 효능
Pasithea Therapeutics (NASDAQ : KTTA) a atteint une étape importante dans son essai clinique de Phase 1 de PAS-004, un inhibiteur macrocyclique de MEK de nouvelle génération. La société a réussi à compléter l'inscription et la première administration de trois sujets dans la cohorte 6, en leur donnant des capsules de PAS-004 de 30 mg.
L'essai en cours est conçu comme une étude multicentrique, ouverte, avec une escalade de dose selon le schéma 3+3, ciblant des patients atteints de tumeurs solides avancées dépendantes de la voie MAPK. L'étude vise spécifiquement des patients présentant des mutations documentées de RAS, NF1 ou RAF, ou ceux n'ayant pas répondu à une inhibition BRAF/MEK.
Le PDG, Dr Tiago Reis Marques, s'est dit satisfait du rythme rapide de recrutement et d'inscription, prévoyant un achèvement complet des inscriptions d'ici fin 2025. L'étude a pour objectif d'évaluer plusieurs aspects de PAS-004, notamment :
- Sécurité et tolérance
- Pharmacocinétique (PK)
- Pharmacodynamie (PD)
- Efficacité préliminaire
Pasithea Therapeutics (NASDAQ: KTTA) hat einen bedeutenden Meilenstein in seiner Phase-1-Studie von PAS-004, einem neuartigen makrozyklischen MEK-Inhibitor, erreicht. Das Unternehmen hat die Einschreibung und erste Dosierung von drei Probanden in Kohorte 6 erfolgreich abgeschlossen und dabei 30 mg Kapseln von PAS-004 verabreicht.
Die laufende Studie ist als multizentrische, offene, Dosissteigerungsstudie nach dem 3+3-Schema konzipiert und konzentriert sich auf Patienten mit fortgeschrittenen soliden Tumoren, die durch den MAPK-Signalweg angetrieben werden. Die Studie richtet sich speziell an Patienten mit dokumentierten RAS-, NF1- oder RAF-Mutationen oder an solche, die nicht auf eine BRAF/MEK-Inhibition angesprochen haben.
Der CEO, Dr. Tiago Reis Marques, zeigte sich zufrieden mit dem schnellen Rekrutierungs- und Einschreibeverlauf und prognostiziert eine vollständige Einschreibung bis Ende 2025. Die Studie zielt darauf ab, verschiedene Aspekte von PAS-004 zu bewerten, darunter:
- Sicherheit und Verträglichkeit
- Pharmakokinetik (PK)
- Pharmakodynamik (PD)
- Vorläufige Wirksamkeit
- Completed enrollment and initial dosing of three subjects in Cohort 6 ahead of schedule
- On track to complete full trial enrollment by end of 2025
- Development of next-generation MEK inhibitor targeting multiple cancer indications
- None.
Insights
Pasithea's Phase 1 enrollment progress shows operational efficiency but represents routine early-stage clinical development without efficacy data.
Pasithea's enrollment of three subjects in Cohort 6 (30 mg) of their PAS-004 trial represents standard progression in early clinical development. The 3+3 dose escalation design they're using is the gold standard approach in oncology trials, prioritizing patient safety through incremental dose increases while monitoring toxicity thresholds.
Their progression to this higher dose cohort suggests acceptable safety at lower doses, though no specific safety data appears in the announcement. The accelerated enrollment pace mentioned by management indicates efficient trial execution, providing a concrete timeline with full enrollment projected by end of 2025.
The trial's focus on MAPK pathway-driven tumors with specific genetic mutations (RAS, NF1, RAF) demonstrates a targeted approach aligned with PAS-004's mechanism as a MEK inhibitor. This patient selection strategy is scientifically sound for a next-generation macrocyclic MEK inhibitor.
While this represents methodical progress through their clinical program, this milestone doesn't provide the efficacy data or complete safety profile that would substantially de-risk their development program. This is a routine step in the lengthy clinical development process for oncology drugs.
MIAMI, April 29, 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 MAPK pathway driven cancer indications, today announced the Company has completed enrollment and initial dosing of three subjects in Cohort 6 with 30 mg capsules of PAS-004.
“We are pleased to have recruited, enrolled and commenced dosing of the initial three subjects in Cohort 6 more rapidly than anticipated and we currently expect to complete enrollment of all patients in the trial by the end of 2025,” said Dr. Tiago Reis Marques, Chief Executive Officer of Pasithea.
The ongoing Phase 1 clinical trial is a multi-center, open-label, dose escalation 3+3 study design to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (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 clinical-stage biotechnology company focused on the discovery, research and development of innovative treatments for central nervous system (CNS) disorders, RASopathies and MAPK pathway driven tumors.
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 of PAS-004 in advanced cancer patients, the Company’s planned Phase 1/1b clinical trial of PAS-004 in adult NF1 patients, 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, pre-clinical 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
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