Pasithea Therapeutics Corp. ( KTTA ) is trading higher in the premarket session on Tuesday with a session volume of 22.14 million compared to the average volume of 2.81 million as per data from Benzinga Pro.

The clinical-stage biotechnology company released interim pharmacodynamic (PD) data from its ongoing Phase 1 trial of PAS-004 in advanced cancer patients.

The data includes results from cohorts 3 and 4A, evaluating 8mg and 15mg capsules, and cohort 4B evaluating 4mg tablets.

The data demonstrates strong target engagement consistent with PAS-004’s favorable pharmacological profile.

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Inhibition of ERK phosphorylation (pERK) is widely recognized as a gold-standard PD biomarker for assessing MEK inhibitor activity. To evaluate target engagement, pERK levels were measured in peripheral blood mononuclear cells (PBMCs) collected from patients at baseline and steady-state at day 22.

Preliminary results demonstrate robust pERK inhibition, with reductions in pERK levels of up to 91% even at the 8mg dose level, in line with a previously developed PK/PD model. This confirms substantial target engagement in patients receiving PAS-004.

Pharmacodynamic activity is supported by encouraging preliminary clinical observations, with several patients achieving stable disease and tumor shrinkage while on PAS-004 treatment.

Notably, one patient in cohort 4A (15mg capsule) with stage 4 KRAS G12R-mutated pancreatic cancer, having progressive disease while on three prior lines of therapy, achieved a tumor volume reduction of -9.8% over 5 months of PAS-004 treatment and currently remains on study.

In April, the external Safety Review Committee recommended that the company’s Phase 1 clinical trial of PAS-004 in advanced cancer should proceed to Cohort 6, 30mg capsule, without modification.

This recommendation was based on the review of the safety data from three patients from Cohort 5 and the absence of any dose-limiting toxicities (DLTs).

In late April, Pasithea Therapeutics ( KTTA ) completed enrollment and initial dosing of three subjects in Cohort 6 with 30 mg capsules of PAS-004. 

In September 2024, Pasithea Therapeutics ( KTTA ) announced safety, tolerability, pharmacokinetic (PK), and preliminary efficacy data from the first two 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.

Price Action: KTTA stock is up 62.7% at $2.33 during the premarket session at last check Tuesday.

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