Pasithea Therapeutics Corp. (NASDAQ: KTTA) shares are gaining significantly traction in the pre-market session today, following the release of promising interim data from its ongoing clinical trials. As of the latest check, KTTA stock saw a remarkable rise, trading at $6.11, representing a 58.91% increase from its previous close on US stock charts.
Pasithea Shared Encouraging Clinical-Trial Results
Pasithea (KTTA) published data from the first phase of clinical trials for PAS-004, which covered pharmacokinetics (PK), safety, and tolerability. PAS-004, a potential treatment for advanced solid tumors triggered by the MAPK pathway, is being investigated in this experiment at four US clinical sites.
These malignancies include those in which BRAF/MEK treatments have been ineffective and those with confirmed mutations in RAS, NF1, or RAF. Preliminary efficacy assessment of PAS-004, safety, tolerability, PK, and pharmacodynamics (PD) are the main areas of emphasis of this open-label, multi-center trial.
PAS-004: A Potential Next-Generation MEK Inhibitor
The clinical data has shown that PAS-004 exhibits a unique PK and safety profile, positioning it as a next-generation MEK inhibitor. Unlike typical MEK inhibitors, which often cause adverse side effects like rash or gastrointestinal toxicity even at low doses, PAS-004 has demonstrated a favorable safety profile. Notably, no such side effects have been observed, and the drug has maintained high exposure levels, further enhancing its potential in treatment.
With a half-life of approximately 70 hours, PAS-004 provides a steady inhibition of target pathways, avoiding the peak plasma toxicities that are common among other MEK inhibitors. This characteristic makes it particularly suitable for treating conditions like Neurofibromatosis type 1 (NF1).
KTTA Observed Early Signs of Efficacy and Future Potential
Additionally, Pasithea reported encouraging early efficacy signs, including a colorectal cancer patient with a BRAF K601E mutation showing prolonged stable disease after receiving continuous treatment through the 6th 28-day dosing cycle. This patient’s response highlights PAS-004’s potential to outperform current MEK inhibitors in both safety and effectiveness.
Pasithea aims to develop PAS-004 as a less frequent dosing option, potentially applicable beyond NF1 to other conditions.
