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Pasithea Therapeutics Announces Activation of Clinical Trial Sites in South Korea for Phase 1/1b Trial of PAS-004 in Adult NF1 Patients
Globenewswireยท 2025-09-16 11:03
Core Insights - Pasithea Therapeutics Corp. has initiated clinical trials for PAS-004, a next-generation macrocyclic MEK inhibitor, in South Korea targeting neurofibromatosis type 1 (NF1) patients with symptomatic plexiform neurofibromas [1][9] Clinical Trial Details - The Phase 1/1b study aims to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of PAS-004 in adult NF1 participants [5] - The trial will be conducted at two sites in South Korea: ASAN Medical Centre and Severance Hospital, which are now actively recruiting participants [2][3] - The study consists of two parts: Part A focuses on dose escalation to identify the recommended Part B dose (RPBD), while Part B will evaluate the recommended phase 2 dose (RP2D) [6] Institutional Background - ASAN Medical Centre is the largest hospital in South Korea with 2,432 beds and a significant NF1 caseload, providing a strong research background for the trial [3] - Severance Hospital, one of the oldest and largest university hospitals in South Korea, has 2,437 beds and treats millions of outpatients annually, enhancing the trial's recruitment potential [4] Objectives of the Study - Primary objectives include assessing the safety and tolerability of PAS-004 over a 28-day treatment cycle and evaluating its preliminary efficacy on target plexiform neurofibromas [5] - Secondary objectives involve identifying the RPBD, characterizing the PK and PD profile, and evaluating the impact on quality of life (QOL) and associated symptoms [5][6]
Pasithea Therapeutics Completes Enrollment and Initial Dosing of First Cohort from its Phase 1/1b Clinical Trial of PAS-004 in Adult NF1 Patients
Globenewswireยท 2025-07-31 11:01
Core Insights - Pasithea Therapeutics Corp. has completed enrollment and initial dosing of three subjects in Cohort 1 of its Phase 1/1b clinical trial for PAS-004, a next-generation macrocyclic MEK inhibitor targeting neurofibromatosis type 1 (NF1) [1][2] Group 1: Clinical Trial Details - The Phase 1/1b study aims to evaluate the safety and tolerability of PAS-004 in adult NF1 patients with symptomatic and inoperable plexiform neurofibromas [3] - The trial consists of two parts: Part A will identify the recommended Part B dose (RPBD) through a modified 3+3 design, while Part B will determine the recommended phase 2 dose (RP2D) [4] - The study will be conducted at five clinical trial sites across Australia, South Korea, and the U.S. [5] Group 2: Drug Profile and Advantages - PAS-004 is designed as a once-daily dosed MEK inhibitor, potentially improving patient compliance compared to current FDA-approved therapies that require twice-daily dosing [2] - The primary objective of the trial includes evaluating the preliminary efficacy of PAS-004 on target neurofibroma volume and associated symptoms [3] - Initial safety data from ongoing trials in advanced cancer patients have been encouraging, leading to optimism about PAS-004's potential for NF1 patients [2][6]
Immuneering Reports Positive Overall Survival Data for Atebimetinib (IMM-1-104) from Ongoing Phase 2a Trial in First-Line Pancreatic Cancer Patients
Globenewswireยท 2025-06-17 10:00
Core Insights - Immuneering Corporation announced positive results from its Phase 2a clinical trial of atebimetinib (IMM-1-104) in combination with modified gemcitabine/nab-paclitaxel (mGnP) for first-line pancreatic cancer patients, showing a 94% overall survival (OS) at 6 months and a 72% progression-free survival (PFS) at the same time point [2][3][6] Group 1: Clinical Trial Results - The trial reported a 39% overall response rate (ORR) and an 81% disease control rate (DCR), with many patients experiencing deepening and durable regressions [6][9] - The median OS and PFS have not yet been reached, indicating ongoing efficacy [6] - The tolerability profile of atebimetinib in combination with mGnP was markedly favorable, with no Grade 3+ adverse events observed in most categories [6][10] Group 2: Future Plans and Milestones - A pivotal trial for atebimetinib in combination with mGnP is planned for 2026, reflecting the company's commitment to advancing this treatment option [1][11][14] - The company has increased target enrollment for the trial to approximately 50 patients based on the encouraging data [6][11] - Immuneering will host a conference call to discuss the data and provide a business update, indicating proactive communication with stakeholders [11]
Pasithea Therapeutics Presents Updated Interim Data from Ongoing Phase 1 Study of PAS-004 at the ASCO Annual Meeting 2025
GlobeNewswire News Roomยท 2025-06-02 12:02
Core Insights - Pasithea Therapeutics Corp. announced promising interim results for PAS-004, a next-generation macrocyclic MEK inhibitor, in a Phase 1 clinical trial targeting advanced cancer patients with MAPK pathway-driven tumors [1][6] Group 1: Clinical Trial Overview - The ongoing Phase 1 study employs a multi-center, open-label, dose escalation design to assess the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary efficacy of PAS-004 [1] - As of April 2, 2025, 21 patients have been enrolled across six cohorts, with pancreatic cancer (28.6%), colorectal cancer (28.6%), and melanoma (23.8%) being the most common diagnoses [2] Group 2: Efficacy and Safety - PAS-004 demonstrated a dose-dependent PK profile and preliminary clinical activity, with 10 out of 16 efficacy evaluable patients achieving stable disease at some point during the trial [5] - One patient with stage 4 BRAF-mutated melanoma showed a tumor volume reduction of -14.9% and has maintained stable disease for over 5 months [1][5] - All treatment-related adverse events were grade 1 or 2, with no known MEK inhibitor class-related adverse events observed [3] Group 3: Pharmacokinetics - Preliminary PK analysis indicates a linear PK profile with an estimated half-life exceeding 60 hours, and sufficient exposures for target engagement were achieved [4] - The peak to trough ratio was below 2 at steady state across all dose levels, supporting the potential for effective treatment [4] Group 4: Future Outlook - The CEO of Pasithea highlighted the potential of PAS-004 as a best-in-class MEK inhibitor, emphasizing its high selectivity and sustained pathway suppression, which may benefit both monotherapy and combination therapy [6] - The company is also conducting a Phase 1/1b clinical trial for PAS-004 in adult patients with neurofibromatosis type 1-associated plexiform neurofibromas [7]
Pasithea Therapeutics Announces Initiation of Phase 1/1B Study of PAS-004 in Adult NF1 Patients and Activation of First Clinical Trial Site
Globenewswireยท 2025-05-14 11:02
Core Insights - Pasithea Therapeutics Corp. has initiated a Phase 1/1b clinical trial for PAS-004, a macrocyclic MEK inhibitor, targeting adult patients with neurofibromatosis type 1 (NF1) and symptomatic plexiform neurofibromas, with the first patient expected to be dosed in Q2 2025 [1][4] Group 1: Clinical Trial Details - The trial aims to evaluate safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary efficacy of PAS-004 in adult NF1 patients [1][5] - The first clinical trial site is located at the Royal North Shore Hospital in Sydney, Australia, with additional sites planned in Australia, South Korea, and the United States [2][6] - The study will be conducted in two parts, with Part A focusing on dose exploration and Part B on determining the recommended phase 2 dose (RP2D) [8][9] Group 2: Financial and Operational Aspects - Pasithea has selected Novotech (Australia) Pty Limited as its clinical research organization (CRO) for the trial and anticipates eligibility for an Australian R&D Tax Incentive, which could provide a cash refund of up to 48.5% of eligible trial costs [3][6] - The company is funded to produce initial interim patient data in NF1 following recent financing activities, including the exercise of certain warrants [4] Group 3: Expert Commentary - Dr. Rebecca Brown, a member of Pasithea's Scientific Advisory Board, expressed optimism about the safety profile of PAS-004 based on previous data from advanced cancer patients and highlighted the importance of patient compliance due to the once-daily dosing regimen [4] - Dr. Tiago Reis Marques, CEO of Pasithea, emphasized the significance of this trial as a milestone for both the company and patients with NF1-related plexiform neurofibromas [4]
Pasithea Therapeutics Drug Shows Tumor Reduction In Pancreatic Cancer, Strong Early Trial Results
Benzingaยท 2025-05-06 13:29
Core Viewpoint - Pasithea Therapeutics Corp. has released promising interim pharmacodynamic data from its ongoing Phase 1 trial of PAS-004 in advanced cancer patients, leading to a significant increase in stock price during premarket trading [1][7]. Group 1: Clinical Trial Data - The Phase 1 trial evaluated different dosages of PAS-004, including 8mg, 15mg capsules, and 4mg tablets, with a focus on pharmacodynamic (PD) activity [1][4]. - Strong target engagement was demonstrated, with pERK levels showing reductions of up to 91% at the 8mg dose, indicating substantial target engagement in patients [2][4]. - Encouraging preliminary clinical observations were noted, with several patients achieving stable disease and tumor shrinkage while on PAS-004 treatment [4]. Group 2: Patient Outcomes - A notable case involved a patient with stage 4 KRAS G12R-mutated pancreatic cancer who experienced a tumor volume reduction of -9.8% over 5 months of treatment with the 15mg capsule [5]. - The external Safety Review Committee recommended proceeding to Cohort 6 (30mg capsule) based on safety data from previous cohorts, with no dose-limiting toxicities reported [6]. Group 3: Market Reaction - Following the release of the trial data, KTTA stock rose by 62.7%, reaching $2.33 during the premarket session [7].
Pasithea Therapeutics Reports Positive Pharmacodynamic Results Demonstrating Robust Target Engagement from its Ongoing Phase 1 Clinical Trial of PAS-004
Globenewswireยท 2025-05-06 11:03
Core Insights - Pasithea Therapeutics Corp. announced positive interim pharmacodynamic data from its Phase 1 trial of PAS-004, a macrocyclic MEK inhibitor targeting neurofibromatosis type 1 and other MAPK pathway-driven cancers [1][5] - The trial demonstrated up to 91% inhibition of pERK, confirming substantial target engagement and a favorable pharmacological profile [1][3] - One patient with stage 4 KRAS G12R mutated pancreatic cancer showed a tumor volume reduction of -9.8% over 5 months of treatment with PAS-004 [1][4] Pharmacodynamic Data - Inhibition of ERK phosphorylation (pERK) is a recognized biomarker for assessing MEK inhibitor activity, with measurements taken from patients at baseline and day 22 [2] - The results indicated robust pERK inhibition, with reductions of up to 91% at the 8mg dose level, aligning with previous PK/PD models [3] Clinical Observations - Preliminary clinical observations showed several patients achieving stable disease and tumor shrinkage while on PAS-004 treatment [4] - The ongoing Phase 1 trial is a multi-center, open-label, dose escalation study evaluating safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy in patients with MAPK pathway-driven advanced solid tumors [5] Company Overview - Pasithea Therapeutics is focused on developing innovative treatments for central nervous system disorders, RASopathies, and MAPK pathway-driven tumors [6]
Pasithea Therapeutics to Present Updated Data from Ongoing Phase 1 Trial of PAS-004 in Advanced Cancer Patients at the 2025 ASCO Annual Meeting
GlobeNewswire News Roomยท 2025-04-24 11:02
Core Viewpoint - Pasithea Therapeutics Corp. announced the acceptance of an abstract for a poster presentation at the ASCO Annual Meeting, highlighting the ongoing Phase 1 clinical trial of PAS-004, a macrocyclic MEK inhibitor for treating neurofibromatosis type 1 and other MAPK pathway-driven conditions [1][2]. Group 1: Clinical Trial Details - The ongoing Phase 1 clinical trial is a multi-center, open-label, dose escalation study designed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary efficacy of PAS-004 in patients with MAPK pathway-driven advanced solid tumors [5]. - Updated interim clinical data from cohorts 4A and 4B of the trial has shown clinical activity, target engagement, and a favorable safety profile [3]. Group 2: Presentation Information - The poster presentation will take place on June 2, 2025, from 1:30 PM to 4:30 PM CDT, under the title "Phase 1 dose-escalation study of the safety and pharmacokinetics of PAS-004" [4]. - The full abstract will be available on the ASCO website on May 22, 2025, at 5:00 PM ET [4]. Group 3: Company Overview - Pasithea Therapeutics is focused on the discovery, research, and development of innovative treatments for central nervous system disorders, RASopathies, and MAPK pathway-driven diseases [6].