Pasithea Therapeutics Announces Initiation of Phase 1/1B Study of PAS-004 in Adult NF1 Patients and Activation of First Clinical Trial Site
Clinical Trial Announcement: Pasithea Therapeutics has initiated a Phase 1/1b clinical trial for its drug PAS-004, aimed at evaluating safety and efficacy in adult patients with neurofibromatosis type 1 (NF1) and plexiform neurofibromas, with the first patient expected to be dosed in Q2 2025.
Trial Details and Funding: The trial will take place across multiple sites in Australia, South Korea, and the U.S., with potential financial support from the Australian R&D Tax Incentive, offering refunds of up to 48.5% on eligible study costs.
Trade with 70% Backtested Accuracy
Analyst Views on KTTAW
No data
About the author
Pasithea Therapeutics Reports Encouraging Pharmacokinetic Data for PAS-004 Tablet in Ongoing Phase 1/1b Trial Involving Adult NF1 Patients
Pharmacokinetics of PAS-004: The tablet formulation of PAS-004 shows linear pharmacokinetics with a dose-proportional increase in exposure, achieving a Cmax/Cmin ratio of less than 2, indicating improved predictability and reduced variability compared to the capsule formulation.
Clinical Trial Results: In ongoing Phase 1/1b studies, the 4mg and 8mg tablet cohorts demonstrated significant pharmacokinetic parameters, with the 8mg tablet showing higher exposure levels than the 22mg capsule, suggesting enhanced efficacy for treating neurofibromatosis type 1-associated plexiform neurofibromas.
Long Half-Life: PAS-004 has a long half-life of approximately 57 hours, which supports once-daily dosing and may contribute to its therapeutic effectiveness in patients with symptomatic and inoperable plexiform neurofibromas.
Company Overview: Pasithea Therapeutics is focused on developing PAS-004 as a treatment for RASopathies and MAPK pathway-driven tumors, currently conducting clinical trials to evaluate its safety, tolerability, and efficacy in various patient populations.
Pasithea Therapeutics Launches Clinical Trial Site at University of Alabama at Birmingham for Ongoing Phase 1/1b Study of PAS-004 in Adult Patients with NF1
New Clinical Trial Site Activation: Pasithea Therapeutics has activated a new clinical trial site at the University of Alabama at Birmingham for its Phase 1/1b study of PAS-004, targeting adult patients with neurofibromatosis type 1 (NF1) and symptomatic plexiform neurofibromas.
Study Objectives and Design: The trial aims to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of PAS-004, with a two-part design involving dose escalation and expansion phases across multiple international sites.
Community Engagement: Pasithea is also serving as the Platinum Sponsor for the 2025 NF Caregivers Symposium at UAB, emphasizing collaboration with caregivers, clinicians, and advocates to improve outcomes for NF1 patients.
Forward-Looking Statements: The press release includes forward-looking statements regarding the company's clinical trials and future business strategies, highlighting the inherent risks and uncertainties associated with such projections.
Pasithea Therapeutics Begins Enrollment of Cohort 2 After Favorable SRC Review for Phase 1/1b Clinical Trial of PAS-004 in Adult NF1 Patients
Trial Progression: Pasithea Therapeutics has received a recommendation from the external Safety Review Committee to escalate the dosage of PAS-004 to 8mg in their Phase 1/1b clinical trial for neurofibromatosis type 1 (NF1), following a review of safety data from initial participants.
Study Objectives: The trial aims to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of PAS-004 in adult NF1 patients, with a focus on symptomatic and inoperable plexiform neurofibromas, and will be conducted across multiple sites in Australia, South Korea, and the U.S.
Pasithea Therapeutics Completes Enrollment and Initial Dosing of First Cohort from its Phase 1/1b Clinical Trial of PAS-004 in Adult NF1 Patients
Clinical Trial Progress: Pasithea Therapeutics has completed enrollment and initial dosing of three subjects in Cohort 1 of its Phase 1/1b clinical trial for PAS-004, a MEK inhibitor aimed at treating neurofibromatosis type 1 (NF1) with symptomatic plexiform neurofibromas.
Future Expectations: The company anticipates presenting initial proof-of-concept data for PAS-004 in NF1 patients by Q1 2026, highlighting its potential as a once-daily treatment option that may improve patient compliance compared to existing therapies.
Pasithea Therapeutics Appoints Expert in ETS2-driven Inflammatory Disease to Scientific Advisory Board
Appointment of Dr. James Lee: Pasithea Therapeutics has appointed Dr. James Lee to its scientific advisory board to assist in the development of PAS-004, a MEK inhibitor targeting ETS2 pathway inflammatory diseases such as IBD and Crohn's disease.
Current Clinical Trials: The company is conducting Phase 1 clinical trials for PAS-004 in advanced cancer patients and NF1-associated plexiform neurofibromas, with plans for further development based on non-dilutive financing options.
Pasithea Therapeutics Announces Preclinical Data that Shows PAS-004 Inhibits ETS2 Signaling, a Key Driver of Inflammation in IBD and Other Large Addressable Market Diseases
Potential of PAS-004: New preclinical data shows that PAS-004, a next-generation MEK inhibitor, significantly outperforms the FDA-approved selumetinib in inhibiting ETS2-driven inflammatory responses, suggesting its potential as a treatment for immune-mediated inflammatory diseases like IBD and ankylosing spondylitis.
Broader Implications: The study indicates that PAS-004 may provide a more effective approach to targeting multiple cytokines involved in chronic inflammation, positioning it as a promising oral treatment option for various inflammatory conditions beyond its initial focus on MAPK pathway-driven tumors.
Pasithea Therapeutics Reports Encouraging Pharmacokinetic Data for PAS-004 Tablet in Ongoing Phase 1/1b Trial Involving Adult NF1 Patients
Pharmacokinetics of PAS-004: The tablet formulation of PAS-004 shows linear pharmacokinetics with a dose-proportional increase in exposure, achieving a Cmax/Cmin ratio of less than 2, indicating improved predictability and reduced variability compared to the capsule formulation.
Clinical Trial Results: In ongoing Phase 1/1b studies, the 4mg and 8mg tablet cohorts demonstrated significant pharmacokinetic parameters, with the 8mg tablet showing higher exposure levels than the 22mg capsule, suggesting enhanced efficacy for treating neurofibromatosis type 1-associated plexiform neurofibromas.
Long Half-Life: PAS-004 has a long half-life of approximately 57 hours, which supports once-daily dosing and may contribute to its therapeutic effectiveness in patients with symptomatic and inoperable plexiform neurofibromas.
Company Overview: Pasithea Therapeutics is focused on developing PAS-004 as a treatment for RASopathies and MAPK pathway-driven tumors, currently conducting clinical trials to evaluate its safety, tolerability, and efficacy in various patient populations.
Pasithea Therapeutics Launches Clinical Trial Site at University of Alabama at Birmingham for Ongoing Phase 1/1b Study of PAS-004 in Adult Patients with NF1
New Clinical Trial Site Activation: Pasithea Therapeutics has activated a new clinical trial site at the University of Alabama at Birmingham for its Phase 1/1b study of PAS-004, targeting adult patients with neurofibromatosis type 1 (NF1) and symptomatic plexiform neurofibromas.
Study Objectives and Design: The trial aims to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of PAS-004, with a two-part design involving dose escalation and expansion phases across multiple international sites.
Community Engagement: Pasithea is also serving as the Platinum Sponsor for the 2025 NF Caregivers Symposium at UAB, emphasizing collaboration with caregivers, clinicians, and advocates to improve outcomes for NF1 patients.
Forward-Looking Statements: The press release includes forward-looking statements regarding the company's clinical trials and future business strategies, highlighting the inherent risks and uncertainties associated with such projections.
Pasithea Therapeutics Begins Enrollment of Cohort 2 After Favorable SRC Review for Phase 1/1b Clinical Trial of PAS-004 in Adult NF1 Patients
Trial Progression: Pasithea Therapeutics has received a recommendation from the external Safety Review Committee to escalate the dosage of PAS-004 to 8mg in their Phase 1/1b clinical trial for neurofibromatosis type 1 (NF1), following a review of safety data from initial participants.
Study Objectives: The trial aims to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of PAS-004 in adult NF1 patients, with a focus on symptomatic and inoperable plexiform neurofibromas, and will be conducted across multiple sites in Australia, South Korea, and the U.S.
Pasithea Therapeutics Completes Enrollment and Initial Dosing of First Cohort from its Phase 1/1b Clinical Trial of PAS-004 in Adult NF1 Patients
Clinical Trial Progress: Pasithea Therapeutics has completed enrollment and initial dosing of three subjects in Cohort 1 of its Phase 1/1b clinical trial for PAS-004, a MEK inhibitor aimed at treating neurofibromatosis type 1 (NF1) with symptomatic plexiform neurofibromas.
Future Expectations: The company anticipates presenting initial proof-of-concept data for PAS-004 in NF1 patients by Q1 2026, highlighting its potential as a once-daily treatment option that may improve patient compliance compared to existing therapies.
Pasithea Therapeutics Appoints Expert in ETS2-driven Inflammatory Disease to Scientific Advisory Board
Appointment of Dr. James Lee: Pasithea Therapeutics has appointed Dr. James Lee to its scientific advisory board to assist in the development of PAS-004, a MEK inhibitor targeting ETS2 pathway inflammatory diseases such as IBD and Crohn's disease.
Current Clinical Trials: The company is conducting Phase 1 clinical trials for PAS-004 in advanced cancer patients and NF1-associated plexiform neurofibromas, with plans for further development based on non-dilutive financing options.
Pasithea Therapeutics Announces Preclinical Data that Shows PAS-004 Inhibits ETS2 Signaling, a Key Driver of Inflammation in IBD and Other Large Addressable Market Diseases
Potential of PAS-004: New preclinical data shows that PAS-004, a next-generation MEK inhibitor, significantly outperforms the FDA-approved selumetinib in inhibiting ETS2-driven inflammatory responses, suggesting its potential as a treatment for immune-mediated inflammatory diseases like IBD and ankylosing spondylitis.
Broader Implications: The study indicates that PAS-004 may provide a more effective approach to targeting multiple cytokines involved in chronic inflammation, positioning it as a promising oral treatment option for various inflammatory conditions beyond its initial focus on MAPK pathway-driven tumors.
