Pasithea Therapeutics Announces Enrollment of Cohort 2 following Positive Safety Review Committee (SRC) Recommendation for its Ongoing Phase 1/1b Clinical Trial of PAS-004 in Adult NF1 Patients
Pasithea Therapeutics (NASDAQ: KTTA) has received approval to advance to Cohort 2 in its Phase 1/1b clinical trial of PAS-004, a next-generation macrocyclic MEK inhibitor for neurofibromatosis type 1 (NF1) patients. The external Safety Review Committee's recommendation follows a successful safety review of Cohort 1, where no dose limiting toxicities were observed in the initial three patients.
The trial will now proceed with Cohort 2, testing an 8mg tablet dosage. The company has already enrolled the first three patients in this cohort, noting strong enrollment demand. Initial interim clinical data from the first two cohorts is expected in Q1 2026.
Pasithea Therapeutics (NASDAQ: KTTA) ha ottenuto l'autorizzazione a procedere con il Cohort 2 nello studio clinico di Fase 1/1b su PAS-004, un inibitore macrocilico di nuova generazione della MEK destinato a pazienti con neurofibromatosi di tipo 1 (NF1). La raccomandazione del Comitato Esterno per la Revisione della Sicurezza arriva dopo la valutazione positiva del Cohort 1, in cui non sono state osservate tossicità dose-limitanti nei primi tre pazienti.
Lo studio proseguirà ora con il Cohort 2, che testerà una compressa da 8 mg. I primi tre pazienti di questo gruppo sono già stati arruolati, con una domanda di partecipazione significativa. I primi dati clinici intermedi relativi ai primi due cohort sono attesi nel Q1 2026.
Pasithea Therapeutics (NASDAQ: KTTA) ha recibido aprobación para avanzar al Cohorte 2 en su ensayo clínico de Fase 1/1b de PAS-004, un inhibidor macrocilíco de la MEK de nueva generación para pacientes con neurofibromatosis tipo 1 (NF1). La recomendación del Comité Externo de Revisión de Seguridad sigue a una revisión satisfactoria del Cohorte 1, donde no se observaron toxicidades limitantes de dosis en los primeros tres pacientes.
El ensayo continuará con el Cohorte 2, evaluando una tableta de 8 mg. La compañía ya ha inscrito a los primeros tres pacientes de este cohorte, señalando una fuerte demanda de incorporación. Se esperan los primeros datos clínicos interinos de los dos primeros cohortes en el Q1 2026.
Pasithea Therapeutics (NASDAQ: KTTA)가 차세대 매크로사이클 MEK 억제제인 PAS-004의 1/1b상 임상시험에서 코호트 2로 진행할 승인을 받았습니다. 외부 안전성 검토위원회의 권고는 코호트 1의 안전성 검토 결과에 따른 것으로, 초기 세 명의 환자에서 투여 용량 제한 독성(dose limiting toxicities)이 관찰되지 않았습니다.
시험은 이제 8mg 정제을 투여하는 코호트 2로 진행됩니다. 회사는 이 코호트의 첫 세 명 환자를 이미 등록했으며, 등록 수요가 높은 것으로 보고했습니다. 첫 두 코호트에 대한 초기 중간 임상 데이터는 2026년 1분기(Q1)에 예상됩니다.
Pasithea Therapeutics (NASDAQ: KTTA) a obtenu l'autorisation de passer au Cohorte 2 de son essai clinique de phase 1/1b portant sur PAS-004, un inhibiteur macrocyclique de MEK de nouvelle génération destiné aux patients atteints de neurofibromatose de type 1 (NF1). La recommandation du comité externe de revue de sécurité fait suite à un bilan favorable du Cohorte 1, où aucune toxicité limitant la dose n'a été observée chez les trois premiers patients.
L'essai se poursuit désormais avec le Cohorte 2, qui testera un comprimé de 8 mg. La société a déjà enrôlé les trois premiers patients de ce groupe, notant une forte demande d'inscription. Les premières données cliniques intermédiaires des deux premiers cohortes sont attendues au T1 2026.
Pasithea Therapeutics (NASDAQ: KTTA) hat die Genehmigung erhalten, in Kohorte 2 seiner Phase-1/1b-Studie zu PAS-004 voranzuschreiten, einem next‑generation makrozyklischen MEK‑Inhibitor für Patienten mit Neurofibromatose Typ 1 (NF1). Die Empfehlung des externen Sicherheitsprüfungsausschusses folgt auf eine erfolgreiche Sicherheitsbewertung von Kohorte 1, in der bei den ersten drei Patienten keine dosislimitierenden Toxizitäten festgestellt wurden.
Die Studie wird nun mit Kohorte 2 fortgesetzt, die eine 8‑mg‑Tablette testet. Die ersten drei Patienten dieser Kohorte sind bereits eingeschlossen, wobei eine starke Anmeldebereitschaft verzeichnet wurde. Erste vorläufige klinische Daten aus den beiden ersten Kohorten werden für das 1. Quartal 2026 (Q1 2026) erwartet.
- No dose limiting toxicities (DLTs) observed in Cohort 1
- Strong enrollment demand reported for the clinical trial
- Successfully advanced to higher dose level (8mg) in Cohort 2
- First three patients already enrolled in Cohort 2
- None.
-- Recommendation that trial escalate to next dose level of 8mg tablet --
-- Initial interim clinical data from first two cohorts expected in Q1 2026 --
MIAMI, Sept. 08, 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 today announced that the external Safety Review Committee recommended that the Company’s Phase 1/1b open label study to assess the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of PAS-004, in adult participants with neurofibromatosis type 1 (NF1) should proceed to Cohort 2, 8mg tablet, without modification. This recommendation was based on the review of the safety data from three patients from Cohort 1 and the absence of any dose limiting toxicities (DLT’s).
“We are seeing substantial enrollment demand and have already enrolled the first three Cohort 2 patients,” stated Dr. Tiago Reis Marques, Chief Executive Officer of Pasithea.
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 PK and 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, 18mg) in a modified 3+3 design. Part A will identify the recommended RPBD. During Part B, approximately 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 Phase 1/1b clinical trial of PAS-004 in adult patients with NF1-associated plexiform neurofibromas, 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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