On Thursday, Pasithea Therapeutics Corp. (NASDAQ:KTTA) announced safety, tolerability, pharmacokinetic (PK), and preliminary efficacy data from the first 2 cohorts of patients (n=6) in its Phase 1 trial of PAS-004 in patients with MAPK pathway-driven advanced solid tumors with a documented RAS, NF1 or RAF mutation or patients who have failed BRAF/MEK inhibition.
Pasithea stock is trading higher on a strong volume of 9.01 million versus an average of 17.3k as per data from Benzinga Pro.
Pharmacokinetics (PK)
- Plasma exposure increased with an increase in dose, and linear PK was observed.
- A long half-life of approximately 70 hours will allow for once-daily dosing or longer intervals.
- Prolonged systemic exposure with minimal fluctuation in PAS-004 plasma concentration at a steady state indicates a potential to achieve constant target inhibition.
Also Read: Neurology Focused Pasithea Therapeutics Stock Soars Over 150% Today – Here’s Why
Safety & Tolerability
- No treatment-related adverse events (TRAEs) or dose-limiting toxicities (DLTs) have been observed to date.
- In the first 2 dosing cohorts (n=6), PAS-004 was shown to be well-tolerated with a favorable safety profile with no drug-related dose interruptions, reductions or discontinuations.
- To date, no rash, skin toxicity, gastrointestinal (GI) toxicity, or ocular toxicity has been observed at the 2 and 4 mg dose levels.
“In addition, we are encouraged to see early potential signs of efficacy, with a heavily pre-treated patient with colorectal cancer showing prolonged stable disease…We are encouraged that this patient has been treated continuously into the 6th 28-day dosing cycle with no toxicities or AEs observed. While still early in clinical development, we believe PAS-004 is showing early signs of differentiation, indicating PAS-004 has the potential to outperform current MEK inhibitors in terms of safety, reduced administration frequency, and potentially efficacy,” stated Tiago Reis Marques, CEO of Pasithea.
The study’s independent Safety Review Committee has completed its safety review of data from the second dose cohort of 4 mg. The company has initiated cohort 3 dosing at an increased dose of 8 mg in capsules and filed a protocol amendment to increase the dosing schedule.
Price Action: At last check Thursday, KTTA stock was up 71.70% at $6.60 during the premarket session.
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