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 results from its Phase 1 clinical trial of PAS-004, a next-generation macrocyclic MEK inhibitor. The Safety Review Committee recommended advancing to cohort 4 with a 15mg capsule dose, following no dose-limiting toxicities in the first 9 patients. Notably, no rash was observed, which is a common adverse event with competitor MEK inhibitors. The company will add cohort 4b to test a commercial formulation. PAS-004 demonstrates advantages over first-generation MEK inhibitors, including a longer half-life of 70 hours enabling once-daily dosing, and consistent plasma levels at steady-state.
Pasithea Therapeutics (NASDAQ: KTTA) ha annunciato risultati positivi di sicurezza dal suo studio clinico di Fase 1 su PAS-004, un inibitore MEK macrociclico di nuova generazione. Il Comitato per la Revisione della Sicurezza ha raccomandato di passare al coorte 4 con una dose di capsula da 15 mg, dopo che non sono state osservate tossicità limitanti da dose nei primi 9 pazienti. In particolare, non è stata osservata alcuna eruzione cutanea, che è un evento avverso comune con gli inibitori MEK concorrenti. L'azienda aggiungerà il coorte 4b per testare una formulazione commerciale. PAS-004 presenta vantaggi rispetto agli inibitori MEK di prima generazione, inclusa un'emivita più lunga di 70 ore che consente la somministrazione una volta al giorno e livelli plasmatici costanti in stato stazionario.
Pasithea Therapeutics (NASDAQ: KTTA) anunció resultados positivos de seguridad de su ensayo clínico de Fase 1 de PAS-004, un inhibidor MEK macrocíclico de nueva generación. El Comité de Revisión de Seguridad recomendó avanzar al cohorte 4 con una dosis de cápsula de 15 mg, tras no observarse toxicidades limitantes por dosis en los primeros 9 pacientes. Notablemente, no se observó erupción cutánea, que es un evento adverso común con los inhibidores MEK competidores. La compañía añadirá el cohorte 4b para probar una formulación comercial. PAS-004 muestra ventajas sobre los inhibidores MEK de primera generación, incluida una vida media más larga de 70 horas que permite una dosificación una vez al día y niveles plasmáticos consistentes en estado estable.
파시티아 테라퓨틱스(Pasithea Therapeutics, NASDAQ: KTTA)는 차세대 매크로사이클 MEK 억제제 PAS-004의 1상 임상 시험에서 긍정적인 안전성 결과를 발표했습니다. 안전성 검토 위원회는 15mg 캡슐 용량으로 4군으로 진행할 것을 권장했습니다, 첫 9명 환자에서 용량 제한 독성이 관찰되지 않았습니다. 특히, 발진은 관찰되지 않았습니다, 이는 경쟁 MEK 억제제에서 일반적인 부작용입니다. 이 회사는 상업적 제형을 테스트하기 위해 4b 군을 추가할 것입니다. PAS-004는 하루 한 번 복용할 수 있도록 70시간의 긴 반감기를 포함하여, 1세대 MEK 억제제에 비해 여러 가지 이점을 보여줍니다.
Pasithea Therapeutics (NASDAQ: KTTA) a annoncé des résultats de sécurité positifs issus de son essai clinique de Phase 1 sur PAS-004, un inhibiteur MEK macrocyclique de nouvelle génération. Le Comité de Révision de la Sécurité a recommandé de passer à la cohorte 4 avec une dose de capsule de 15 mg, après l'absence de toxicités limitant la dose chez les 9 premiers patients. Notamment, aucune éruption cutanée n'a été observée, ce qui est un événement indésirable courant avec les inhibiteurs MEK concurrents. L'entreprise ajoutera la cohorte 4b pour tester une formulation commerciale. PAS-004 présente des avantages par rapport aux inhibiteurs MEK de première génération, y compris une demi-vie plus longue de 70 heures permettant une posologie quotidienne unique et des niveaux plasmatiques constants à l'état d'équilibre.
Pasithea Therapeutics (NASDAQ: KTTA) hat positive Sicherheitsdaten aus seiner klinischen Phase 1-Studie zu PAS-004, einem nächsten Generation makrozyklischen MEK-Inhibitor, bekannt gegeben. Das Sicherheitsteam empfahl, zur Kohorte 4 mit einer Dosis von 15 mg Kapsel überzugehen, nachdem bei den ersten 9 Patienten keine dosislimitierenden Toxizitäten beobachtet wurden. Bemerkenswerterweise wurde kein Ausschlag beobachtet, was ein häufiges unerwünschtes Ereignis bei konkurrierenden MEK-Inhibitoren ist. Das Unternehmen wird Kohorte 4b hinzufügen, um eine kommerzielle Formulierung zu testen. PAS-004 zeigt Vorteile gegenüber MEK-Inhibitoren der ersten Generation, einschließlich einer längeren Halbwertszeit von 70 Stunden, die eine einmal tägliche Dosierung ermöglicht, sowie konsistenten Plasmaspiegeln im steady state.
- No dose-limiting toxicities observed in Phase 1 trial
- Absence of rash side effect, which is common in competitor drugs
- PAS-004 shows superior half-life (70 hours) compared to competitors (<8 hours)
- Drug enables once-daily dosing vs. twice-daily for existing treatments
- Trial advancing to higher dose level, indicating good safety profile
- None.
Insights
The Phase 1 trial data for PAS-004 shows promising early safety signals. The absence of rash and dose-limiting toxicities through three dose cohorts is particularly noteworthy, as these are common issues with existing MEK inhibitors. The 70-hour half-life of PAS-004 could enable once-daily dosing, a significant improvement over current twice-daily treatments.
The pharmacokinetic profile showing consistent plasma levels and low Cmax/Cmin ratio suggests better tolerability. The addition of cohort 4b to test the commercial formulation indicates confidence in the drug's potential progression. However, while safety data is encouraging, efficacy data is still pending and the trial is in early stages with only 9 patients treated so far.
-- SRC recommended that the trial escalate to the next dose level of 15mg capsule --
-- No dose-limiting toxicities (DLTs) observed to date --
-- No rash observed to date --
MIAMI, Nov. 20, 2024 (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 proceeding to cohort 4, 15mg capsule, without modifications. This recommendation was based on the absence of any dose limiting toxicities (DLT’s). In addition, no rash was observed in any of the first 9 patients who received PAS-004. The Company has decided to add a cohort 4b to the trial, which will consist of 3 additional patients and introduce an alternate formulation which is intended for commercial use.
Dr. Tiago Reis Marques, Chief Executive Officer of Pasithea stated, “We are pleased to observe that as we continue to dose escalate, we have not yet seen rash emerge. 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. In addition, we are excited to dose patients with our potential commercial formulation.”
The 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).
PAS-004 Demonstrates a Differentiated MEK Inhibitor Profile
Unlike first-generation MEK inhibitors for the treatment of NF1 that require twice-daily dosing (BID) and exhibit short half-lives (<8 hours), PAS-004 has the potential to achieve prolonged target inhibition and once-daily dosing (QD) due to its long half-life of approximately 70 hours. As disclosed previously, the PK profile shows consistent plasma levels at steady-state, as reflected by a low Cmax to Cmin ratio, potentially reducing the risks for Cmax-related toxicity. These findings provide a compelling rationale for the advancement of PAS-004 into clinical trials for both the treatment of cutaneous and plexiform neurofibromas in NF1, cancer and other MAPK-driven opportunities. The company expects to provide additional trial updates on a periodic basis as the trial progresses.
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) 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
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