Significant Milestones Achieved in PAS-004 Toxicity Studies

Promising Outcomes from PAS-004 Chronic Toxicity Studies

Pasithea Therapeutics Corp. (NASDAQ: KTTA) is creating waves in the biotechnology sector with the recent completion of its chronic toxicity studies for PAS-004, a cutting-edge macrocyclic MEK inhibitor. This compound is being developed for treating neurofibromatosis type 1 (NF1) and other cancer-related conditions. These studies mark a significant step forward, encompassing both rats and dogs, revealing encouraging results that bolster the company's future clinical endeavors.

Study Results Indicate Solid Safety Profile

The comprehensive studies lasted for an extended duration, confirming earlier findings from 28-day toxicity examinations. By administering PAS-004 once daily for six months in rats and extending the trial to nine months for dogs, the research indicated a reassuring safety profile across both species. The dogs’ study established the no adverse effect level (NOAEL) at 0.5 mg/kg. Remarkably, this finding solidifies PAS-004's consistent safety profile and its potential for effective cancer therapies.

Long-term Dosing Insights

The studies showed that long-term dosing of PAS-004 not only matched the previously established safety profile but also seemed to correlate with effective pathway engagement. Dosages below the NOAEL are expected to yield significant reductions in pERK, a key component in tumor growth pathways. The robust data emerging from these studies reinforces the potential of PAS-004 as a preferred choice among MEK inhibitors in the market.

Clinical Applications and Future Trials

With mainly crystal form PAS-004 being utilized in human clinical trials, the consistent adverse event profile across its amorphous predecessor indicates promising prospects as the company prepares for patient dosing. The insights from these studies are anticipated to pave the way for more refined clinical practice, effectively targeting cancer cells while minimizing side effects, a significant concern with traditional therapies.

Comments from Leadership

Dr. Tiago Reis Marques, the CEO of Pasithea, expressed optimism regarding PAS-004's potential, asserting that sustained suppression of the Mitogen Associated Protein Kinase (MAPK) pathway might lead to enhanced efficacy. He also highlighted the company's eagerness to unveil further data on PAS-004, especially initial interim results from their Phase 1 clinical trials, which promise to deliver critical markers for its pharmacokinetic (PK) and pharmacodynamic (PD) profiles.

About Pasithea Therapeutics Corp.

Pasithea Therapeutics stands as a beacon in the realm of clinical-stage biotechnology, passionately devoted to innovating solutions for central nervous system (CNS) disorders and RASopathies. The company’s dedicated team, comprised of experts in neuroscience and drug development, is on an urgent quest to unveil new treatments for debilitating neurological conditions. PAS-004 is just one of their ambitious projects, which also includes research on solid tumors and diseases like Amyotrophic Lateral Sclerosis (ALS).

Frequently Asked Questions

What is PAS-004 developed by Pasithea Therapeutics?

PAS-004 is a next-generation macrocyclic MEK inhibitor designed to target neurofibromatosis type 1 (NF1) and other cancers, currently undergoing clinical trials.

What were the findings of the chronic toxicity studies?

The studies indicated a favorable safety profile for PAS-004, matching earlier 28-day study results, and establishing the NOAEL level at 0.5 mg/kg for dogs.

How long were the PAS-004 studies conducted?

The studies were conducted over six months in rats and nine months in dogs, providing extensive data on its safety and long-term effects.

What does the NOAEL mean for PAS-004?

NOAEL stands for No Adverse Effect Level; it indicates the maximum dose at which no harmful effects were observed, guiding safe dosing in future clinical trials.

What are Pasithea's future plans regarding PAS-004?

Pasithea plans to share more data on PAS-004, including initial results from its first-in-human Phase 1 clinical study, expected within the upcoming quarter.

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