Pasithea Therapeutics Completes Enrollment and Initial Dosing of First Cohort from its Phase 1/1b Clinical Trial of PAS-004 in Adult NF1 Patients
Pasithea Therapeutics (NASDAQ: KTTA) has achieved a significant milestone in its clinical development program by completing enrollment and initial dosing of three subjects in Cohort 1 of its Phase 1/1b trial for PAS-004. The trial evaluates a novel once-daily macrocyclic MEK inhibitor in adult patients with neurofibromatosis type 1 (NF1) who have symptomatic and inoperable plexiform neurofibromas.
The company expects to present initial interim safety, tolerability, biomarker, and preliminary efficacy data in Q1 2026. PAS-004 aims to differentiate itself from current FDA-approved therapies that require twice-daily dosing, potentially offering better patient compliance and tolerability advantages.
Pasithea Therapeutics (NASDAQ: KTTA) ha raggiunto un traguardo importante nel suo programma di sviluppo clinico completando l'arruolamento e la somministrazione iniziale a tre soggetti nel Gruppo 1 del suo trial di Fase 1/1b per PAS-004. Lo studio valuta un nuovo inibitore macrocilico MEK somministrato una volta al giorno in pazienti adulti con neurofibromatosi di tipo 1 (NF1) che presentano neurofibromi plessiformi sintomatici e inoperabili.
L'azienda prevede di presentare i primi dati intermedi su sicurezza, tollerabilità, biomarcatori e efficacia preliminare nel primo trimestre del 2026. PAS-004 si propone di differenziarsi dalle terapie attualmente approvate dalla FDA, che richiedono una somministrazione due volte al giorno, offrendo potenzialmente un miglioramento nella compliance del paziente e nella tollerabilità.
Pasithea Therapeutics (NASDAQ: KTTA) ha alcanzado un hito significativo en su programa de desarrollo clínico al completar la inscripción y la dosificación inicial de tres sujetos en la Cohorte 1 de su ensayo de Fase 1/1b para PAS-004. El ensayo evalúa un nuevo inhibidor macro cíclico de MEK de administración diaria en pacientes adultos con neurofibromatosis tipo 1 (NF1) que presentan neurofibromas plexiformes sintomáticos e inoperables.
La compañía espera presentar los primeros datos interinos sobre seguridad, tolerabilidad, biomarcadores y eficacia preliminar en el primer trimestre de 2026. PAS-004 busca diferenciarse de las terapias aprobadas por la FDA que requieren dos dosis diarias, ofreciendo potencialmente mejores ventajas en cumplimiento y tolerabilidad para los pacientes.
파시테아 테라퓨틱스(NASDAQ: KTTA)는 PAS-004의 1상/1b상 임상시험 1코호트에서 3명의 피험자 등록 및 초기 투여를 완료하며 임상 개발 프로그램에서 중요한 이정표를 달성했습니다. 이 시험은 증상이 있고 수술이 불가능한 신경섬유종증 1형(NF1) 성인 환자를 대상으로 하는 새로운 하루 한 번 복용하는 매크로사이클릭 MEK 억제제를 평가합니다.
회사는 2026년 1분기에 초기 중간 안전성, 내약성, 바이오마커 및 예비 효능 데이터를 발표할 예정입니다. PAS-004는 하루 두 번 복용해야 하는 현재 FDA 승인 치료제와 차별화하여 환자의 복약 순응도와 내약성을 개선할 가능성을 목표로 합니다.
Pasithea Therapeutics (NASDAQ : KTTA) a franchi une étape importante dans son programme de développement clinique en complétant l'inscription et la première administration à trois sujets du Cohorte 1 de son essai de Phase 1/1b pour PAS-004. L'essai évalue un nouveau inhibiteur macrocyclique de MEK à prise quotidienne chez des patients adultes atteints de neurofibromatose de type 1 (NF1) présentant des neurofibromes plexiformes symptomatiques et inopérables.
L'entreprise prévoit de présenter les premières données intermédiaires sur la sécurité, la tolérance, les biomarqueurs et l'efficacité préliminaire au premier trimestre 2026. PAS-004 vise à se différencier des thérapies actuellement approuvées par la FDA qui nécessitent une administration deux fois par jour, offrant potentiellement une meilleure observance et une meilleure tolérance pour les patients.
Pasithea Therapeutics (NASDAQ: KTTA) hat einen bedeutenden Meilenstein in seinem klinischen Entwicklungsprogramm erreicht, indem die Einschreibung und erste Dosierung von drei Probanden in Kohorte 1 seiner Phase 1/1b-Studie für PAS-004 abgeschlossen wurde. Die Studie bewertet einen neuartigen einmal täglich einzunehmenden makrozyklischen MEK-Inhibitor bei erwachsenen Patienten mit Neurofibromatose Typ 1 (NF1), die symptomatische und nicht operable plexiforme Neurofibrome aufweisen.
Das Unternehmen plant, erste Zwischenberichte zu Sicherheit, Verträglichkeit, Biomarkern und vorläufiger Wirksamkeit im ersten Quartal 2026 vorzustellen. PAS-004 soll sich von derzeit von der FDA zugelassenen Therapien unterscheiden, die eine zweimal tägliche Einnahme erfordern, und bietet potenziell Vorteile bei der Patienten-Compliance und Verträglichkeit.
- None.
- Early-stage clinical development with efficacy yet to be proven
- Results not expected until Q1 2026
- Small initial cohort size of only three subjects
– Initial interim safety, tolerability, biomarker, and preliminary efficacy data expected in Q1 2026 –
MIAMI, July 31, 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 Company has completed enrollment and initial dosing of three subjects in Cohort 1 (4mg tablet) from its ongoing Phase 1/1b multicenter, open-label clinical trial evaluating PAS-004 in adult NF1 patients with symptomatic and inoperable, incompletely resected, or recurrent plexiform neurofibromas.
“Completion of enrollment and initial dosing of Cohort 1 marks a key milestone in our mission to develop PAS-004 as a potential best-in-class, next-generation MEK inhibitor for the treatment of NF1,” stated Dr. Tiago Reis Marques, Chief Executive Officer of Pasithea. “PAS-004 is a once-daily dosed MEK inhibitor in development for the treatment of NF1 patients with plexiform neurofibromas, as opposed to the current FDA-approved therapies that require twice-daily dosing. This may potentially offer a best-in-class advantage in terms of patient compliance. Based on the initial encouraging safety profile observed to date in our ongoing Phase 1 trial in advanced cancer patients, we are optimistic about the potential of PAS-004 to offer the NF1 population a better-tolerated MEK inhibitor and look forward to presenting initial NF1 proof-of-concept data in Q1 2026.”
About the Phase 1/1b Clinical Trial in Adult NF1 Patients
The primary objective of the Phase 1/1b study (NCT06961565) is to evaluate the safety and tolerability of PAS-004 when administered for one 28-day treatment cycle in adult NF1 participants with at least one and up to two additional target plexiform neurofibromas (PNs) that are symptomatic and inoperable, incompletely resected, or recurrent. Secondary objectives are (i) to identify the recommended Part B dose (RPBD) or Maximum Tolerated Dose (MTD) of PAS-004, (ii) to characterize the pharmacokinetics (PK) and pharmacodynamics (PD) profile of PAS-004, (iii) to evaluate the preliminary efficacy of PAS-004 on target PN volume, (iv) to evaluate the preliminary efficacy of PAS-004 on the size, appearance, and associated symptoms of cutaneous neurofibromas (CNs), and (v) to evaluate the impact of PAS-004 on quality of life (“QOL”) and any physical symptoms attributed to the target PN. Experimental objectives are (i) to evaluate the impact of PAS-004 on QOL and any physical symptoms attributed to CNs, (ii) to evaluate the impact of PAS-004 on pain and function attributed to PNs, and (iii) to investigate PAS-004 effects on CN tumor cellular and molecular biology.
The trial will be conducted in two parts. In Part A, following a screening period of up to 28 days, up to 24 eligible participants will be enrolled sequentially to receive one of four planned dose levels of PAS-004 tablets (4mg, 8mg, 12 mg, and 18mg) in a modified 3+3 design. Part A will identify the recommended RPBD. During Part B, up to 24 eligible participants will be enrolled in parallel to receive one of two planned dose levels of PAS-004 tablets. Participants will be dosed at the RPBD level and at a dose level below the RPBD for up to six continuous 28-day treatment cycles. Part B will identify the recommended phase 2 dose (RP2D).
The study is planned to be conducted at five clinical trial sites in Australia, South Korea and the U.S.
About Pasithea Therapeutics Corp.
Pasithea is a clinical-stage biotechnology company primarily focused on the research and development of its lead drug candidate, PAS-004, a next-generation macrocyclic MEK inhibitor intended for the treatment of RASopathies, MAPK pathway-driven tumors, and other diseases. The Company is currently testing PAS-004 in a Phase 1 clinical trial in advanced cancer patients (NCT06299839), and a Phase 1/1b clinical trial in adult patients with neurofibromatosis type 1 (NF1) associated plexiform neurofibromas (NCT06961565).
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 ongoing 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 and financing 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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