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Investing.com -- Pasithea Therapeutics Corp (NASDAQ:KTTA) stock plummeted 25% in after-hours trading Thursday following the release of interim Phase 1 data for its MEK inhibitor PAS-004.
The clinical-stage biotech company reported initial results from its first-in-human trial evaluating PAS-004 in patients with MAPK pathway-driven advanced solid tumors. Despite the company highlighting a partial response in one melanoma patient and a disease control rate of 71.4% in patients with BRAF-mutated tumors, investors appeared unimpressed with the overall efficacy profile.
The trial data showed that among 21 efficacy-evaluable patients, only one achieved a partial response - a BRAF V600E melanoma patient who showed a 31.9% tumor reduction and remains on trial for over 11 months. A second melanoma patient achieved stable disease with minimal tumor shrinkage of 1.6% after six months of treatment.
Pasithea reported that PAS-004 demonstrated a favorable safety profile with all treatment-related adverse events being Grade 1 or 2, with no ocular or cardiovascular toxicities observed. Common side effects included nausea (18.5%), vomiting (14.8%), rash (7.4%), and diarrhea (7.4%).
The company is developing PAS-004 as a potential treatment for neurofibromatosis type 1-associated plexiform neurofibromas (NF1-PN). The drug showed dose-proportional pharmacokinetics with an AUC of approximately 5,480 ng·h/mL at the 30mg capsule dose.
Despite management’s optimistic interpretation of the data, the significant stock decline suggests investors had expected stronger efficacy signals from this interim readout.
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