Pasithea Therapeutics Unveils Promising Phase 1 Data for PAS-004, Showcasing Robust Target Engagement in Cancer Treatment

May 6, 2025

DENVER, Colo., May 06, 2025 (247marketnews.com)- Pasithea Therapeutics (NASDAQ:KTTA) reported compelling interim pharmacodynamic (PD) data from its ongoing Phase 1 clinical trial. The results, covering cohorts 3 (8mg capsules), 4A (15mg capsules), and 4B (4mg tablets), demonstrate robust target engagement, with up to 91% inhibition of phosphorylated ERK (pERK), a key biomarker for MEK inhibitor activity. A standout clinical observation, a stage 4 pancreatic cancer patient achieving 9.8% tumor reduction and over five months of stable disease, underscores PAS-004’s potential in the $50 billion oncology therapeutics market, positioning Pasithea as a rising star in precision medicine.

Dr. Tiago Reis Marques, Pasithea’s CEO, stated, “With today’s update, we are pleased that PAS-004 has demonstrated clinically meaningful reductions in pERK levels at dose levels that are both well-tolerated and safe, with no rash observed. We believe PAS-004’s profile offers the potential to finely modulate MAPK pathway activity, enabled by its previously reported long half-life and favorable pharmacokinetic (PK) profile with a Cmax/Cmin ratio below 2. We’re also encouraged by the emerging clinical signals we’re seeing across multiple cancer types and look forward to sharing further safety, PK and PD data in the coming months.”

Breakthrough Pharmacodynamic Results

The Phase 1 trial, a multi-center, open-label, dose-escalation 3+3 study (ClinicalTrials.gov: NCT06299839), evaluates PAS-004’s safety, tolerability, pharmacokinetics (PK), PD, and preliminary efficacy in patients with advanced solid tumors harboring RAS, NF1, or RAF mutations, or those who failed BRAF/MEK inhibition. PD data, measured by pERK levels in peripheral blood mononuclear cells (PBMCs) at baseline and day 22, revealed reductions of up to 91% at the 8mg dose, confirming substantial target engagement consistent with PAS-004’s favorable PK profile, characterized by a long half-life and a Cmax/Cmin ratio below 2. This robust inhibition, even at lower doses, aligns with a prior PK/PD model, highlighting PAS-004’s ability to modulate the MAPK pathway effectively.

Clinical observations further bolster these findings. A patient in cohort 4A (15mg capsule) with stage 4 KRAS G12R-mutated pancreatic cancer, previously progressing on three lines of therapy, achieved a 9.8% tumor volume reduction and over five months of stable disease, remaining on study. Other patients across cohorts reported stable disease and tumor shrinkage, signaling PAS-004’s potential across multiple cancer types.

Strategic Context and Market Opportunity

PAS-004’s interim data positions Pasithea to address unmet needs in NF1 and MAPK-driven cancers, a market projected to grow at a 7% CAGR through 2030 (MarketsandMarkets). Unlike existing MEK inhibitors, PAS-004’s macrocyclic design offers enhanced specificity and reduced toxicity, as evidenced by the absence of rash—a common side effect. The pancreatic cancer patient’s 9.8% tumor reduction is particularly significant, given the disease’s 5-year survival rate of ~12% (American Cancer Society, 2025). Pasithea’s focus on precision oncology aligns with industry trends, akin to Firefly Neuroscience’s Evoke acquisition (May 5, 2025), where strategic moves amplify market potential. The trial’s multi-center design and inclusion of diverse mutations enhance PAS-004’s applicability, targeting a $50 billion oncology therapeutics market.

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