Pasithea Therapeutics Corp. is a biotechnology company focuses on the research and discovery of new and treatments for psychiatric and neurological disorders. The company was founded by Yassine Bendiabdallah and Steinman Lawrence J in May, 2020 and is headquartered in Miami Beach, FL.
相关临床试验
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成立时间
2020
进行中（未招募）
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- Pasithea Therapeutics completed a $60 million public offering led by prominent healthcare investors to fund development of PAS-004, a next-generation MEK inhibitor. - The company is currently testing PAS-004 in Phase 1 clinical trials for advanced cancer patients and Phase 1/1b trials for neurofibromatosis type 1-associated plexiform neurofibromas. - The funding extends Pasithea's cash runway through at least the first half of 2028, supporting ongoing clinical development and research activities. - PAS-004 represents a novel macrocyclic oral MEK inhibitor designed to treat RASopathies, MAPK pathway-driven tumors, and other related diseases.
- The ALS Association awarded Pasithea Therapeutics approximately $1 million through its Hoffman Clinical Trial Awards Program to study PAS-004, a next-generation macrocyclic MEK inhibitor, in ALS patients. - The Phase 1 study will evaluate PAS-004 in twelve ALS patients across three sequential dose cohorts over approximately 28 weeks, marking the first clinical trial of this MEK inhibitor in ALS. - PAS-004 targets MAPK and MEK enzymes involved in TDP-43-related neurodegeneration and neuroinflammation, with promising preclinical results in the SOD mouse model of ALS. - The trial will assess safety and tolerability while measuring changes in ALS Functional Rating Scale-Revised scores and neurofilament light chain levels as potential biomarkers of clinical activity.
- Pasithea Therapeutics announced preclinical data showing PAS-004 provides superior inhibition of ETS2-driven inflammatory responses compared to FDA-approved selumetinib in a human macrophage model mimicking IBD inflammation. - The study conducted at Francis Crick Institute demonstrated PAS-004's greater downregulation of ETS2 target genes across all tested doses, suggesting more robust MEK inhibition under inflammatory conditions. - PAS-004 significantly reduced key macrophage inflammatory functions including cytokine production, phagocytosis, and reactive oxygen species generation, positioning it as a potential oral treatment for IBD and other inflammatory diseases. - The findings suggest PAS-004 could target multiple cytokines including IL-1β, which is not directly modulated by current JAK inhibitors, potentially offering broader therapeutic benefits than existing treatments.
- DelveInsight's 2025 pipeline report reveals over 10 pharmaceutical companies are actively developing 12+ therapies for neurofibromatoses treatment across various clinical stages. - Key developments include Healx Limited's HLX-1502 entering Phase II trials for NF1 patients and Shanghai Fosun Pharmaceutical's FCN-159 advancing to Phase III development. - The pipeline features diverse therapeutic approaches including MEK inhibitors, with companies like Pasithea Therapeutics and NFlection Therapeutics contributing novel small molecule candidates. - Leading pharmaceutical companies such as Novartis are conducting long-term studies assessing dabrafenib and trametinib effects in pediatric neurofibromatoses patients.
- Pasithea Therapeutics has closed a $5 million public offering of common stock and warrants, with additional proceeds of $1.3 million from warrant exercises. - The clinical-stage biotech is developing PAS-004, a next-generation macrocyclic MEK inhibitor targeting neurofibromatosis type 1 (NF1) and other cancer indications. - Proceeds will support ongoing research, clinical trials, and potential strategic acquisitions to advance the company's pipeline of CNS disorder and MAPK pathway-driven tumor treatments.
- Pasithea Therapeutics' Phase 1 trial of PAS-004 demonstrated up to 91% inhibition of pERK, confirming substantial target engagement in advanced cancer patients at doses as low as 8mg. - The MEK inhibitor has shown a favorable safety profile with no dose-limiting toxicities or rash observed in the first 19 patients, a significant advantage over competitor drugs that typically cause rash in over 80% of patients. - A stage 4 pancreatic cancer patient with KRAS G12R mutation achieved tumor volume reduction of 9.8% and maintained stable disease for over 5 months, suggesting promising clinical activity.
- Pasithea Therapeutics has broadened its Phase 1 clinical trial for PAS-004 by opening new sites in Romania and Bulgaria, actively recruiting patients. - The trial is evaluating PAS-004, a next-generation MEK inhibitor, for advanced solid tumors with specific MAPK pathway mutations. - Initial dosing has been completed for Cohort 4A (15mg capsule), with ongoing recruitment for Cohort 4B (4mg tablet) participants. - Interim safety and pharmacokinetic data from Cohorts 4A and 4B are anticipated in Q1 2025, offering insights into PAS-004's efficacy.
- PAS-004, a next-generation MEK inhibitor, demonstrates a tolerable safety profile in early phase 1 trial cohorts of patients with advanced MAPK-driven cancers. - The trial observed no drug-related serious adverse effects or dose interruptions at 2 mg and 4 mg doses, with no reports of rash, gastrointestinal, or ocular toxicities. - Pharmacokinetic data reveals a long half-life of approximately 70 hours and a flat pharmacokinetic curve at steady-state, potentially enabling constant target inhibition. - Early signs of efficacy were observed in a heavily pretreated patient with BRAF K601E-mutated colorectal cancer, showing prolonged stable disease during treatment.
- Pasithea Therapeutics has commenced a Phase 1 clinical trial for PAS-004, a next-generation macrocyclic MEK inhibitor, at four U.S. sites. - The open-label, multicenter trial aims to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy of PAS-004 in patients with advanced solid tumors and NF1. - PAS-004 is the first macrocyclic MEK inhibitor in human trials, potentially offering improved compliance, selectivity, and a longer half-life compared to existing MEK inhibitors. - Interim data from the Phase 1 trial is anticipated in the second half of 2024, with plans for a Phase 2 trial in NF1 patients pending safety and PK assessments.
