KTTA's PAS-004 Tablet Delivers Proportional PK Exposure and Predictability in NF1 Trial

Key Trial Insight: PAS-004 Tablet Achieves More Favorable Pharmacokinetics Than Capsule Formulation

Pasithea Therapeutics (NASDAQ: KTTA) has reported new clinical pharmacokinetic (PK) results for its PAS-004 tablet formulation in adults with neurofibromatosis type 1 (NF1). The ongoing Phase 1/1b trial demonstrates that PK exposure with the tablet form increases proportionally with the dose, delivering improved predictability and reduced patient variability compared to the earlier capsule formulation. Notably, steady-state PK data revealed a Cmax/Cmin ratio under 2, and dose-normalized exposures that were about three times higher with the tablet than the capsule—allowing a lower dose tablet to match the exposure of a much higher-dose capsule.

Dose Proportionality and Exposure: Detailed Cohort Data at a Glance

Tablet formulations were tested at 4mg and 8mg doses in adults with symptomatic or inoperable NF1-related tumors. Key findings:

The 8mg tablet resulted in an area under the curve (AUC) and Cmax slightly above those measured for a 22mg capsule. This means a lower dose tablet delivers comparable or even superior exposure—offering a clear advantage for both patient dosing convenience and predictable therapeutic levels.

Steady-State Profile Suggests Improved Patient Outcomes

The data show both 4mg and 8mg tablet doses maintain Cmax and Cmin values above the IC50 (the concentration needed for 50% maximal effect in preclinical assays). Additionally, patient variability in exposure was lower for tablets, a desirable property for precision dosing and long-term safety. A half-life of roughly 57 hours suggests potential for once-daily dosing and manageable steady-state levels.

What This Means for Pasithea’s Clinical Program

Switching from capsule to tablet appears to confer notable benefits in pharmacokinetics, potentially improving patient adherence, efficacy predictability, and tolerability as clinical trials advance. These data may help support regulatory discussions and strengthen KTTA’s position in treating RASopathies like NF1-associated plexiform neurofibromas, as well as other MAPK pathway-driven tumors. The company continues its Phase 1/1b trial in NF1, alongside a separate Phase 1 program in advanced cancers.

Key Takeaway: Tablet PK Profile Supports Optimism for KTTA’s Next Steps

For investors and clinical watchers, the PAS-004 tablet’s PK data present a strong case for improved formulation over the capsule—offering better patient experience and more robust drug exposure at lower doses. As additional clinical data emerges, it will be important to watch whether these PK advantages translate into tangible safety and efficacy outcomes for patients with challenging NF1 and tumor diagnoses.

For more details or to view accompanying trial graphics, visit the full announcement from Pasithea Therapeutics and consult official sources.

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