Pasithea Therapeutics Announces Activation of Clinical Trial Sites in South Korea for Phase 1/1b Trial of PAS-004 in Adult NF1 Patients
Pasithea Therapeutics (NASDAQ: KTTA) has announced the activation of two major clinical trial sites in South Korea for its Phase 1/1b study of PAS-004, a next-generation macrocyclic MEK inhibitor. The trial will evaluate the drug's safety, tolerability, and pharmacokinetics in adult patients with neurofibromatosis type 1 (NF1) who have symptomatic and inoperable plexiform neurofibromas.
The activated sites include ASAN Medical Centre and Severance Hospital, which together have access to an estimated 10,000 NF1 patients in South Korea. Professor Lee Beom-Hee from ASAN Medical Center, which has the largest NF1 caseload in South Korea, will lead the trial at their facility. The drug PAS-004 has shown a distinct pharmacokinetic profile and offers a more convenient dosing regimen compared to existing treatments.
Pasithea Therapeutics (NASDAQ: KTTA) ha annunciato l'attivazione di due importanti centri di sperimentazione clinica in Corea del Sud per lo studio di fase 1/1b di PAS-004, un inibitore macrociclico MEK di ultima generazione. Lo studio valuterà la sicurezza, la tollerabilità e la farmacocinetica del farmaco in pazienti adulti con neurofibromatosi di tipo 1 (NF1) che presentano neurofibromatosomi plexiformi sintomatici e non operabili.
I siti attivati includono ASAN Medical Centre e Severance Hospital, che insieme hanno accesso a circa 10.000 pazienti NF1 in Corea del Sud. Il professor Lee Beom-Hee dell'ASAN Medical Center, che detiene la maggior quantità di casi NF1 in Corea, guiderà lo studio presso la loro struttura. PAS-004 ha mostrato un profilo farmacocinetico distinto e propone un regime di dosaggio più conveniente rispetto ai trattamenti esistenti.
Pasithea Therapeutics (NASDAQ: KTTA) ha anunciado la activación de dos importantes centros de ensayos clínicos en Corea del Sur para su estudio de fase 1/1b de PAS-004, un inhibidor MEK macrocíclico de próxima generación. El ensayo evaluará la seguridad, la tolerabilidad y la farmacocinética del fármaco en pacientes adultos con neurofibromatosis tipo 1 (NF1) que presentan neurofibromas plexiformes sintomáticos e inoperables.
Los centros activados incluyen ASAN Medical Centre y Severance Hospital, que en conjunto tienen acceso a aproximadamente 10.000 pacientes NF1 en Corea del Sur. El profesor Lee Beom-Hee del ASAN Medical Center, que tiene la mayor carga de NF1 en Corea, dirigirá el ensayo en su instalación. PAS-004 ha mostrado un perfil farmacocinético distinto y ofrece un régimen de dosificación más cómodo en comparación con los tratamientos existentes.
Pasithea Therapeutics (NASDAQ: KTTA)가 PAS-004의 1상/1b 연구를 위한 한국 내 두 개의 주요 임상시험 사이트를 활성화했다고 발표했습니다. 차세대 거대 고리형 MEK 억제제인 PAS-004는 성인 NF1(신경섬유종증 1형)에서 증상 있는 비수술적 플렉시포름 신경섬유종을 가진 환자들의 안전성, 내약성 및 약물동역학을 평가할 예정입니다.
활성화된 사이트로는 ASAN Medical Centre와 Severance Hospital이 포함되며, 이들 합산으로 한국에서 약 만국 NF1 환자 10,000명에 접근할 수 있습니다. ASAN Medical Center는 한국에서 NF1 사례가 가장 많은 곳으로, 이곳의 연구를 이수민 교수가 이끌 예정이며 시설에서 시험이 진행됩니다. PAS-004는 독특한 약동학적 프로필을 보였고 기존 치료에 비해 더 편리한 투여 일정이 제시됩니다.
Pasithea Therapeutics (NASDAQ: KTTA) a annoncé l’activation de deux sites d’essais cliniques majeurs en Corée du Sud pour son essai de phase 1/1b de PAS-004, un inhibiteur MEK macrocyclique de nouvelle génération. L’essai évaluera la sécurité, la tolérabilité et la pharmacocinétique du médicament chez des adultes atteints de neurofibromatose type 1 (NF1) présentant des neurofibromes plexiformes symptomatiques et inopérables.
Les sites activés comprennent ASAN Medical Centre et Severance Hospital, qui ont ensemble accès à environ 10 000 patients NF1 en Corée du Sud. Le professeur Lee Beom-Hee de l’ASAN Medical Center, qui traite le plus grand nombre de cas NF1 en Corée, dirigera l’essai dans leurs locaux. PAS-004 a montré un profil pharmacocinétique distinct et offre un régime posologique plus pratique que les traitements existants.
Pasithea Therapeutics (NASDAQ: KTTA) hat die Aktivierung von zwei wichtigen klinischen Studienzentren in Südkorea für seine Phase-1/1b-Studie von PAS-004, einen neuartigen macrozyklischen MEK-Inhibitor, bekannt gegeben. Die Studie wird die Sicherheit, Verträglichkeit und Pharmakokinetik des Medikaments bei erwachsenen Patienten mit Neurofibromatose Typ 1 (NF1) untersuchen, die symptomatische und operativ nicht entfernbare plexiforme Neurofibrome haben.
Zu den aktivierten Standorten gehören ASAN Medical Centre und Severance Hospital, die zusammen Zugang zu schätzungsweise 10.000 NF1-Patienten in Südkorea haben. Prof. Lee Beom-Hee vom ASAN Medical Center, der die größte NF1-Fallzahl in Korea betreut, wird die Studie an ihrer Einrichtung leiten. PAS-004 hat ein deutliches pharmakokinetisches Profil gezeigt und bietet ein praktischeres Dosierungsschema im Vergleich zu bestehenden Behandlungen.
تم الإعلان عن تفعيل موقعين رئيسيين للتجارب السريرية في كوريا الجنوبية من قبل Pasithea Therapeutics (المدرجة في ناسداك: KTTA) للدراسة من المرحلة 1/1b لـ PAS-004، وهو مثبِّط MEK دائري كبير من الجيل التالي. ستقيّم التجربة سلامة الدواء وتحمله وعلم الحركة الدوائية لدى مرضى بالغين مصابين بالتصلُّب العصبي الليفي من النوع 1 NF1 والذين لديهم ورم عصبي شوكي شكلي بؤري وغير قابل للجراحة.
تشمل المواقع المفعّلة مركز ASAN الطبي ومستشفى سيڤينس، والتي تجمعان سويًا الوصول إلى ما يقارب 10,000 مريض NF1 في كوريا الجنوبية. سيقود البروفسور لي بوم-هي من مركز ASAN الطبي الدراسة في منشأتهم، وهو الأكثر عبءًا في حالات NF1 في كوريا. أظهر PAS-004 ملفًا دوائيًا حيويًا مميزًا ويوفّر نظام جرّ أكثر راحة مقارنة بالعلاجات القائمة.
Pasithea Therapeutics (NASDAQ: KTTA) 已宣布在韩国启用两大临床试验中心，开展其 PAS-004 1/1b 研究，这是一种新一代巨环MEK抑制剂。该试验将评估该药物在患有1型神经纤维瘤病（NF1）的成人患者中，具有症状性且无法手术切除的丛状神经纤维瘤的安全性、耐受性和药代动力学。
被激活的中心包括ASAN Medical Centre 与 Severance Hospital，两者合起来在韩国可接触到约10,000 名 NF1 患者。来自 ASAN 医疗中心、在韩国NF1病例数最多的李范熙教授将带队在其机构进行试验。PAS-004 展现了独特的药代动力学特征，相较于现有治疗方案，提供了更为便利的给药方案。
- Access to approximately 10,000 NF1 patients in South Korea through world-class facilities
- PAS-004 demonstrates improved pharmacokinetic profile and more convenient dosing regimen
- Partnership with South Korea's largest hospital and leading NF1 research institution
- None.
Insights
Pasithea's NF1 drug trial expansion to South Korea accelerates patient recruitment with access to 10,000 potential participants.
Pasithea Therapeutics has expanded its Phase 1/1b clinical trial of PAS-004 to South Korea, activating two major medical centers and dosing their first South Korean patient. This represents significant operational progress for their lead candidate, a next-generation macrocyclic MEK inhibitor targeting neurofibromatosis type 1 (NF1) patients with plexiform neurofibromas.
The strategic expansion to Asan Medical Center and Severance Hospital - both premier healthcare institutions with specialized NF1 expertise - gives Pasithea access to an estimated
Particularly notable is the partnership with Professor Lee Beom-Hee at Asan Medical Center, who brings significant NF1 research experience, including pioneering work on MEK inhibition for neurocognitive symptoms. His endorsement of PAS-004's "distinct pharmacokinetic profile and more convenient dosing regimen" provides clinical validation for Pasithea's differentiation strategy.
This trial evaluates critical endpoints including safety, tolerability, pharmacokinetics, and pharmacodynamics - standard but essential parameters for early-phase development. The South Korean expansion creates a multinational dimension to the data collection, potentially strengthening the robustness of results across different populations. For a small biotech with a market cap under
First patient in South Korea dosed
MIAMI, Sept. 16, 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 activation of two South Korean clinical trial sites participating in its 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) with symptomatic and inoperable, incompletely resected, or recurrent plexiform neurofibromas.
The South Korea clinical trial sites, ASAN Medical Centre and Severance Hospital Yonsei University Health System, are now actively recruiting NF1 trial participants.
Professor Lee Beom-Hee of the Department of Pediatrics at Asan Medical Center said, “I am very pleased to partner with the Pasithea team to initiate testing of PAS-004 in adult patients with plexiform neurofibromas associated with NF1 at Asan Medical Center. Our institution has the largest NF1 caseload in South Korea and a long history of research leadership in this field. Our team was among the first to report the therapeutic benefits of MEK inhibition on neurocognitive decline, café-au-lait spots, and growth retardation caused by neurofibromatosis. We are eager to evaluate PAS-004, a next-generation MEK inhibitor that to date has demonstrated a distinct pharmacokinetic profile and a more convenient dosing regimen, which we believe may provide important benefits for our NF1 patients.”
Dr. Tiago Reis Marques, chief executive officer of Pasithea commented, “With access to world-class facilities and an estimated 10,000 NF1 patients in South Korea, we believe our clinical sites in the country will play a pivotal role in the success of this trial. We are excited to include South Korean patients in our NF1 study and look forward to advancing meaningful treatment options for this community.”
Asan Medical Center is a reference hospital and the teaching hospital of the University of Ulsan College of Medicine, located in Seoul, South Korea. With 2,432 beds for patients and a total floor area of approximately 280,000 square meters, it is the largest hospital in South Korea.
Severance Hospital is a teaching hospital located in Sinchon-dong, Seodaemun District, South Korea. It is one of the oldest and biggest university hospitals in South Korea. It has 2,437 beds and treats approximately 2,500,000 outpatients and 840,000 inpatients annually.
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 (dose escalation phase), 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, 12mg, 18mg) in a modified 3+3 design. Part A will identify the recommended RPBD. During Part B (expansion phase), 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
What is the purpose of Pasithea Therapeutics' Phase 1/1b trial for PAS-004?
Which clinical trial sites has KTTA activated in South Korea?
How many NF1 patients could potentially be accessed through KTTA's South Korean trial sites?
What advantages does PAS-004 offer compared to existing treatments?
Who is leading the PAS-004 trial at ASAN Medical Center?
