Pasithea Therapeutics

Pasithea Therapeutics (NASDAQ: KTTA) is excited to share positive initial safety, tolerability, pharmacokinetic (PK) and preliminary efficacy data from the first 2 cohorts of patients (n=6) in its Phase 1 clinical trial of PAS-004 in advanced cancer, being conducted at four clinical sites in the United States. Key Findings: Safety:  No treatment-related adverse events (TRAEs) or dose-limiting toxicities (DLTs) observed to date, including no rash or gastrointestinal (GI) AEs Pharmacokinetics (PK):  Plasma exposure increased with an increase in dose and linear PK is observed Long half-life of approximately 70 hours  Prolonged systemic exposure with minimal fluctuation in PAS-004 plasma concentration at steady state (Cmax/Cmin ratio of 1.2) - indicates a potential to achieve constant target inhibition.   Tolerability:  Long half-life of approximately 70 hours will allow for once daily dosing or longer intervals Efficacy:  Single patient in 2mg cohort with stage 3 colon cancer who received 4 prior lines of therapy achieves prolonged stable disease and remains on drug into 6th dosing cycle PAS-004 is a small molecule allosteric inhibitor of MEK 1/2 and the first macrocyclic MEK inhibitor to enter human clinical trials. The distinctive pharmacokinetic and safety profile highlights its potential as a next-generation MEK inhibitor, providing a unique profile among MEK inhibitors used for the treatment of Neurofibromatosis type 1 (NF1). We remain committed to advancing PAS-004 through clinical development to bring new hope to patients in need. For more details, visit: https://lnkd.in/dD2PzSY7 #Biotech #ClinicalTrials #Oncology #Neurofibromatosis #DrugDevelopment #PasitheaTherapeutics #Pharmacokinetics #PAS004 #NF1 #MAPK

Pasithea Therapeutics will attend and provide a company update during the H.C. Wainwright 26th Annual Global Investment Conference in NYC, from September 9th through September 11th. Pasithea management is pleased to be meeting investors during the conference. Kindly contact pgaynes@pasithea.com, or request through the conference portal for 1x1 meetings during the event. #HCWGlobalInvestment2024 #KTTA #biotech https://lnkd.in/gDr659zv

Congratulations to the team on completion of enrollment and initial dosing for Cohort 2 in our ongoing Phase 1 clinical trial of PAS-004, following a positive recommendation from the Safety Review Committee (SRC). Key Highlights: · Trial Progress: Completed the first dose cohort (2mg) with no dose-limiting toxicities or significant adverse events. · Next Steps: Enrollment and initial dosing for the second cohort (4mg) are complete. · Upcoming Milestones: Initial interim safety and pharmacokinetic (PK) data expected in Q3 2024. Stay tuned for more updates as we advance our mission to innovate treatments for challenging conditions! #MEKi #MAPK #PAS004 #SafetyReviewCommittee #KTTA #NF1 https://lnkd.in/dwbHbrUk

Active session at ASCO 2024 this weekend during our poster presentation: PAS-004: A novel macrocyclic MEK inhibitor inhibits cancer cell growth in vitro and tumor growth in mouse xenograft studies. #ASCO24 #PAS004 #MEKinhibitor #NF1 #NRAS #KTTA

Pasithea Therapeutics' abstract on PAS-004 has been accepted for poster presentation at the ASCO 2024 Annual Meeting. Join us to learn about our macrocyclic MEK inhibitor for the treatment of NF1 and other indications. #ASCO2024 #NF1 #PAS004 #MEKInhibitor https://lnkd.in/ezwxyi2H

We are proud to have completed the initial dosing of the first cohort in our Phase 1 trial (NCT06299839) and look forward to enrolling patients into higher-dose cohorts.   This milestone represents a significant step forward in bringing our next-generation MEK inhibitor for the treatment of neurofibromatosis type 1 (NF1). We are excited about the potential impact of PAS-004 in the lives of those affected by NF1 and aim to initiate a clinical trial of PAS-004 in NF1 patients with plexiform and/or cutaneous neurofibromas in the near future.   A heartfelt thank you to all patients and medical teams involved in this trial.    #NF1 #PAS004 #KTTA #ClinicalTrials #MEKInhibitor #MAPKPathway https://lnkd.in/eFecR_NB

Pasithea Therapeutics is pleased to announce that four U.S. clinical trial sites in Texas and Virginia are now open and actively enrolling patients for the Phase 1 clinical trial of PAS-004. This trial will assess the safety, pharmacokinetics (PK), pharmacodynamics (PD) and preliminary activity (efficacy) of PAS-004 in advance solid tumors and will define the preliminary recommended dose for the Phase 2 clinical trial in Neurofibromatosis type 1 (NF1) patients. We are grateful for our dedicated team's efforts and looking forward to share interim data in 2H 2024.  #PAS004 #Macrocyclic #MEKinhibitor #NF1 #MAPK https://lnkd.in/eeQ-y7xj

Congratulations to our chemistry, manufacturing, and controls (CMC) development team for achieving a significant milestone with the invention of a crystalline form of PAS-004. Our newly filed polymorph and stereoisomer patent applications, when issued, will extend PAS-004 patent protection to at least 2045.   We are pleased that our upcoming Phase 1 dose escalation trial will utilize the newly invented crystalline drug substance.   #Macrocycle #PasitheaTherapeutics #DrugDevelopment #PAS004 #MEKinhibitor #PolymorphPatent #StereoisomerPatent #Nasdaq #KTTA https://lnkd.in/eCF4-5me

We are pleased to announce that the FDA has accepted our IND application for PAS-004, marking it as the first macrocyclic MEK inhibitor to enter human clinical trials. Our Phase 1 dose escalation clinical trial will commence in the current quarter. The objectives of the dose escalation trial are to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics as well as anti-tumor responses of PAS-004 as monotherapy in advanced tumors driven by the MAPK pathway. Stay tuned for the initial study readouts, expected as early as Q3 2024. #PasitheaTherapeutics #KTTA #ClinicalTrials #InvestigationalNewDrug #FDA #Biotech #PAS004 #MEKi #MAPK https://lnkd.in/eBp7gCBk

Pasithea has chosen a humanized monoclonal antibody targeting α5β1 integrin, as its lead candidate for treating both sporadic and familial ALS. This selection follows extensive research demonstrating marked improvements in behavior and survival in ALS mouse models. PAS-003's unique features include inhibiting fibronectin effectively, high specificity, and potency, as confirmed by cryo-EM studies. CEO Dr. Tiago Reis Marques highlighted the antibody's readiness for production and referenced its association with ALS in a prestigious scientific journal. Pasithea chairman, Dr. Lawrence Steinman, expressed enthusiasm and credited collaborative efforts that led to this promising development. #ALSResearch #Biotechnology #KTTA #ALS #monoclonalantibody #PNAS https://lnkd.in/ecZE-McM