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Pasithea Therapeutics Announces Positive PAS-004 Tablet Pharmacokinetic (PK) Data in Ongoing Phase 1/1b Trial in Adult NF1 Patients
Globenewswire· 2025-11-21 17:35
Core Insights - Pasithea Therapeutics Corp. announced positive pharmacokinetic (PK) data for its oral MEK inhibitor PAS-004, indicating improved properties in tablet form compared to capsules [1][2] Pharmacokinetics (PK) - The tablet formulation of PAS-004 (4mg and 8mg cohorts) showed a Cmin of 37.6 ng/mL, with dose-normalized exposures approximately three times higher than the capsule formulation [2] - The 8mg tablet demonstrated an area under the curve (AUC) and Cmax slightly greater than the 22mg capsule, with less patient variability and a similar Tmax range [2] - Cohort 1 (4mg tablet) results: AUC of 1,120 ng·h/mL and Cmax of 58.1 ng/mL; Cohort 2 (8mg tablet) results: AUC of 2,290 ng·h/mL, Cmax of 118 ng/mL, and Cmin of 75.4 ng/mL [3] Company Overview - Pasithea Therapeutics is focused on developing PAS-004 for treating neurofibromatosis type 1-associated plexiform neurofibromas and other diseases, currently in Phase 1 clinical trials [6]
Annovis Reports Peer-Reviewed Publication Highlighting Pharmacokinetics of Novel Crystal Buntanetap
Globenewswire· 2025-09-16 11:30
Core Insights - Annovis Bio, Inc. has published a new article in the peer-reviewed journal Biomolecules detailing the pharmacokinetic profile of a new crystal form of buntanetap, which is being developed for neurodegenerative diseases like Alzheimer's and Parkinson's [1][2]. Group 1: New Crystal Form of Buntanetap - The newly identified dihydrate crystal form of buntanetap offers greater stability compared to the original anhydrous form, which has been used in all previous studies [2]. - The publication confirms that the new crystal form maintains the pharmacokinetic profile and metabolism essential for the drug's therapeutic efficacy [2][4]. Group 2: Clinical Trials and Intellectual Property - The new crystal form of buntanetap is currently being utilized in a pivotal Phase 3 clinical trial (NCT06709014) for early Alzheimer's disease, with key readouts expected in Fall 2026 and Fall 2027 [4]. - This new form extends the intellectual property protection of the lead compound into the 2040s, covering its mechanism of action, therapeutic use, and potential combinations with other drugs [4]. Group 3: Company Commitment and Communication - The company emphasizes its commitment to rigorous analysis of buntanetap to ensure beneficial outcomes for patients [4]. - Annovis Bio is dedicated to developing innovative therapies aimed at improving patient outcomes and quality of life in neurodegenerative diseases [6].