Pasithea’s PAS-004 advances in cancer trial with no toxicities

Published 05/02/2025, 13:06
Pasithea’s PAS-004 advances in cancer trial with no toxicities

MIAMI - Pasithea Therapeutics Corp. (NASDAQ: KTTA), a micro-cap biotech firm with a market capitalization of $2.63 million focusing on developing treatments for central nervous system disorders and RASopathies, announced Wednesday that its Phase 1 clinical trial of PAS-004 will progress to a higher dose level after a favorable review of safety data. According to InvestingPro analysis, the company maintains a strong liquidity position with a current ratio of 14.81, indicating robust short-term financial stability. The trial, targeting advanced cancers with MAPK pathway mutations, will now test a 22mg capsule of the investigational drug.

The Safety Review Committee’s decision follows the absence of dose-limiting toxicities (DLTs) in the first 14 patients, including 12 treated with the capsule form and two with tablets. For investors seeking deeper insights, InvestingPro offers 12 additional investment tips and comprehensive financial metrics to better evaluate biotech investments like KTTA. Importantly, no incidences of rash, a common adverse event associated with competitor MEK inhibitors, were reported. This side effect often leads to discontinuation of treatment in clinical practice.

Pasithea’s CEO, Dr. Tiago Reis Marques, expressed optimism about the safety profile of PAS-004, a macrocyclic MEK inhibitor with a half-life exceeding 60 hours. The company, whose stock is currently trading near its 52-week low of $2.03, anticipates that this drug could transform treatment options for patients with neurofibromatosis type 1 (NF1) and inoperable plexiform neurofibromas. Despite recent market performance showing a 67.5% decline over the past year, analysis suggests the stock may be undervalued at current levels.

The ongoing study (NCT06299839) is a multi-center, open-label trial using a 3+3 dose-escalation design. It aims to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary efficacy of PAS-004 in patients with advanced solid tumors driven by RAS, NF1, or RAF mutations, or in those who have not responded to BRAF/MEK inhibition.

Pasithea plans to present updated PK and PD data during the first quarter of 2025, as the trial continues to gather evidence on the drug’s effects.

This news is based on a press release statement and does not imply endorsement of the claims. The company’s forward-looking statements are subject to risks and uncertainties, and actual results may differ materially from current expectations. Pasithea does not undertake any obligation to update these statements after the date of the release, except as required by law. The company’s next earnings report is expected on March 28, 2025, which could provide additional insights into its financial position and clinical progress.

This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.

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