Pasithea Therapeutics to Present Updated Data from Ongoing Phase 1 Trial of PAS-004 in Advanced Cancer Patients at the 2025 ASCO Annual Meeting
Pasithea Therapeutics (NASDAQ: KTTA) has announced that it will present updated interim clinical data from its ongoing Phase 1 trial of PAS-004, a next-generation macrocyclic MEK inhibitor, at the 2025 ASCO Annual Meeting in Chicago. The presentation will take place on June 2, 2025, from 1:30 – 4:30 PM CDT.
The trial focuses on patients with MAPK pathway driven advanced solid tumors and has shown promising results through cohorts 4A and 4B, demonstrating clinical activity, target engagement, and a favorable safety profile. PAS-004 is being developed for treating neurofibromatosis type 1 (NF1) and other MAPK pathway driven indications.
The Phase 1 clinical trial (NCT06299839) is designed as a multi-center, open-label, dose escalation 3+3 study, evaluating safety, tolerability, pharmacokinetic, pharmacodynamic, and preliminary efficacy in patients with documented RAS, NF1 or RAF mutations, or those who have failed BRAF/MEK inhibition.
Pasithea Therapeutics (NASDAQ: KTTA) ha annunciato che presenterà dati clinici intermedi aggiornati del suo studio di Fase 1 in corso su PAS-004, un inibitore macrocilico di nuova generazione del MEK, al Congresso Annuale ASCO 2025 a Chicago. La presentazione si terrà il 2 giugno 2025, dalle 13:30 alle 16:30 CDT.
Lo studio si concentra su pazienti con tumori solidi avanzati guidati dalla via MAPK e ha mostrato risultati promettenti nei coorti 4A e 4B, dimostrando attività clinica, coinvolgimento del target e un profilo di sicurezza favorevole. PAS-004 è sviluppato per il trattamento della neurofibromatosi di tipo 1 (NF1) e di altre patologie legate alla via MAPK.
Lo studio clinico di Fase 1 (NCT06299839) è uno studio multicentrico, open-label, con escalation di dose secondo il modello 3+3, volto a valutare sicurezza, tollerabilità, farmacocinetica, farmacodinamica ed efficacia preliminare in pazienti con mutazioni documentate in RAS, NF1 o RAF, o in quelli che hanno fallito la terapia con inibitori BRAF/MEK.
Pasithea Therapeutics (NASDAQ: KTTA) ha anunciado que presentará datos clínicos interinos actualizados de su ensayo de Fase 1 en curso sobre PAS-004, un inhibidor macro cíclico de MEK de próxima generación, en la Reunión Anual ASCO 2025 en Chicago. La presentación tendrá lugar el 2 de junio de 2025, de 1:30 a 4:30 PM CDT.
El ensayo se centra en pacientes con tumores sólidos avanzados impulsados por la vía MAPK y ha mostrado resultados prometedores en las cohortes 4A y 4B, demostrando actividad clínica, compromiso del objetivo y un perfil de seguridad favorable. PAS-004 se está desarrollando para el tratamiento de la neurofibromatosis tipo 1 (NF1) y otras indicaciones relacionadas con la vía MAPK.
El ensayo clínico de Fase 1 (NCT06299839) es un estudio multicéntrico, abierto, con escalada de dosis 3+3, que evalúa la seguridad, tolerabilidad, farmacocinética, farmacodinámica y eficacia preliminar en pacientes con mutaciones documentadas en RAS, NF1 o RAF, o en aquellos que han fallado la inhibición de BRAF/MEK.
Pasithea Therapeutics (NASDAQ: KTTA)는 차세대 매크로사이클릭 MEK 억제제인 PAS-004의 진행 중인 1상 임상시험 중간 업데이트 데이터를 2025년 시카고에서 열리는 ASCO 연례회의에서 발표할 예정입니다. 발표는 2025년 6월 2일 오후 1시 30분부터 4시 30분 CDT까지 진행됩니다.
본 임상시험은 MAPK 경로에 의해 진행되는 고형암 환자를 대상으로 하며, 4A 및 4B 코호트에서 임상 활성, 타겟 결합 및 우수한 안전성 프로파일을 보여주는 유망한 결과를 나타냈습니다. PAS-004는 신경섬유종증 1형(NF1) 및 기타 MAPK 경로 관련 적응증 치료제로 개발 중입니다.
1상 임상시험(NCT06299839)은 다기관, 공개, 3+3 용량 증량 방식으로 설계되었으며, RAS, NF1 또는 RAF 돌연변이가 확인된 환자 또는 BRAF/MEK 억제제 치료에 실패한 환자에서 안전성, 내약성, 약동학, 약력학 및 예비 효능을 평가합니다.
Pasithea Therapeutics (NASDAQ : KTTA) a annoncé qu'elle présentera des données cliniques intermédiaires mises à jour de son essai de Phase 1 en cours sur PAS-004, un inhibiteur macrocyclique de MEK de nouvelle génération, lors de la réunion annuelle ASCO 2025 à Chicago. La présentation aura lieu le 2 juin 2025, de 13h30 à 16h30 CDT.
L'essai porte sur des patients atteints de tumeurs solides avancées liées à la voie MAPK et a montré des résultats prometteurs dans les cohortes 4A et 4B, démontrant une activité clinique, un engagement ciblé et un profil de sécurité favorable. PAS-004 est développé pour le traitement de la neurofibromatose de type 1 (NF1) et d'autres indications liées à la voie MAPK.
L'essai clinique de Phase 1 (NCT06299839) est une étude multicentrique, ouverte, avec escalade de dose selon le schéma 3+3, évaluant la sécurité, la tolérance, la pharmacocinétique, la pharmacodynamique et l'efficacité préliminaire chez des patients présentant des mutations documentées RAS, NF1 ou RAF, ou chez ceux ayant échoué à une inhibition BRAF/MEK.
Pasithea Therapeutics (NASDAQ: KTTA) hat angekündigt, dass es aktualisierte Zwischenberichte aus der laufenden Phase-1-Studie zu PAS-004, einem neuartigen makrozyklischen MEK-Inhibitor, auf dem ASCO Jahreskongress 2025 in Chicago präsentieren wird. Die Präsentation findet am 2. Juni 2025 von 13:30 bis 16:30 Uhr CDT statt.
Die Studie konzentriert sich auf Patienten mit fortgeschrittenen soliden Tumoren, die durch den MAPK-Signalweg getrieben werden, und zeigte vielversprechende Ergebnisse in den Kohorten 4A und 4B, mit klinischer Aktivität, Zielbindung und einem günstigen Sicherheitsprofil. PAS-004 wird zur Behandlung von Neurofibromatose Typ 1 (NF1) und anderen durch den MAPK-Signalweg bedingten Indikationen entwickelt.
Die Phase-1-Studie (NCT06299839) ist eine multizentrische, offene Dosis-Eskalationsstudie im 3+3-Design, die Sicherheit, Verträglichkeit, Pharmakokinetik, Pharmakodynamik und vorläufige Wirksamkeit bei Patienten mit dokumentierten RAS-, NF1- oder RAF-Mutationen oder bei Patienten, die auf eine BRAF/MEK-Inhibition nicht angesprochen haben, bewertet.
- Positive interim clinical data showing activity and favorable safety profile
- Successfully completed cohorts 4A and 4B of Phase 1 trial
- Demonstrated target engagement in clinical trials
- None.
Insights
Positive interim Phase 1 data for PAS-004 shows clinical activity with favorable safety profile; ASCO presentation validates scientific interest.
Pasithea's announcement provides meaningful interim clinical signals for their lead candidate PAS-004, a macrocyclic MEK inhibitor. The data through cohorts 4A and 4B demonstrates three critical early-stage development markers: clinical activity, target engagement, and favorable safety. This trifecta is particularly noteworthy for MEK inhibitors, which historically face challenging toxicity-efficacy balance issues.
The decision by ASCO to accept this abstract represents peer validation of the data's scientific merit. ASCO's selection process is highly competitive, particularly for early-stage molecules, suggesting the preliminary results have crossed meaningful thresholds of interest.
The 3+3 dose escalation design is following standard oncology development protocols, with the study strategically targeting patients with RAS, NF1, or RAF mutations - genetic drivers of the MAPK pathway. This positions PAS-004 to address both rare disease applications (NF1-related neurofibromas) and broader cancer indications where MAPK dysregulation occurs.
What's particularly interesting is management's emphasis on achieving the "sweet spot between PK, PD and tolerability" - suggesting they believe they've optimized the pharmacokinetic/pharmacodynamic relationship that often challenges MEK inhibitor development. For a small-cap biotech with a
Poster presentation on Monday, June 2, 2025 from 1:30 – 4:30 PM CDT at the ASCO Annual Meeting
MIAMI, April 24, 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 indications, today announced the acceptance of an abstract for a poster prenstation at the Annual Meeting of the American Society for Clinical Oncology (ASCO) taking place May 30 – June 3, 2025, in Chicago, Illinois.
The Company will present updated interim clinical data from its onging Phase 1 clinical trial of PAS-004 in patients with MAPK pathway driven advanced solid tumors.
“We are pleased to present interim clinical data of PAS-004 through cohort 4A and 4B, that to date has demonstrated clinical activity, target engagement, and a favorable safety profile,” said Dr. Tiago Reis Marques, Chief Executive Officer of Pasithea. “We believe PAS-004’s emerging profile may achieve the sweet spot between PK, PD and tolerability and may make PAS-004 an ideal candidate for the treatment of NF1 related cutaneous and plexiform neurofibromas as well as a potential candidate for treatment of various cancers and MAPK pathway driven diseases.”
Presentation and poster details
Title: Phase 1 dose-escalation study of the safety and pharmacokinetics of PAS-004, a macrocyclic MEK inhibitor, for the treatment of patients with MAPK pathway–driven advanced solid tumors
Session: Poster Session – Developmental Therapeutics – Molecularly Targeted Agents and Tumor Biology
Poster Board: 440
Date and Time: 6/2/2025, 1:30 – 4:30 PM CDT
The full abstract will be available on the ASCO® website on May 22, 2025, at 5:00 p.m. ET.
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 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 diseases.
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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