KTTA PASITHEA THERAPEUTICS CORP

Pasithea Therapeutics Abstract Accepted for Poster Presentation at 2023 Neurofibromatosis Conference

Pasithea Therapeutics Abstract Accepted for Poster Presentation at 2023 Neurofibromatosis Conference

Features Preclinical data of PAS-004 in Plexiform Neurofibroma

PALO ALTO, Calif. and MIAMI, June 01, 2023 (GLOBE NEWSWIRE) -- (NASDAQ: KTTA) (“Pasithea” or the “Company”), a biotechnology company focused on the discovery, research, and development of innovative treatments for central nervous system (CNS) disorders, today announced that pre-clinical results for its lead drug candidate, PAS-004, have been accepted for a poster presentation at the 2023 Neurofibromatosis (NF) Conference taking place June 24-27, 2023, in Scottsdale, Arizona.

“We are extremely pleased to be presenting preclinical data from PAS-004 conducted in collaboration with Dr. Wade Clapp at Indiana University, School of Medicine,” commented Dr. Graeme Currie, Pasithea’s Chief Development Officer. “The presentation will provide insight into PAS-004 efficacy and support further development of our lead candidate.”

Findings will be shared on a poster entitled “Evaluation of the Effects of a Novel MEK inhibitor PAS-004 in Plexiform Neurofibroma in a Pre-clinical Mouse Model of Neurofibromatosis Type 1”. Poster will be available to view during the 2023 NF Conference on the evening of Sunday, June 25th, from 5:00pm - 7:00pm.

About NF conference

First held in 1985 as a roundtable of 20 participants, the NF Conference is now the most important scholarly gathering of the NF research and clinical communities. The NF Conference is a global event organized by Children's Tumor Foundation (CTF), now attracting nearly 750 participants worldwide across a wide range of scientific disciplines, from research and clinical backgrounds, all focused on improving outcomes for patients with neurofibromatosis type 1 (NF1), neurofibromatosis type 2 (NF2) and schwannomatosis. The NF Conference is a critical forum for consensus building and advancing basic, translational, and clinical research in NF and related fields, while fostering collaborations within and beyond the NF community. Importantly, the NF Conference is a key venue for attracting and growing new investigators in NF research and clinical care.

About PAS-004

PAS-004 is a small molecule allosteric inhibitor of MEK 1/2 in the MAPK signaling pathway. The MAPK pathway has been implicated in a variety of diseases, as it functions to drive cell proliferation, differentiation, survival and a variety of other cellular functions that, when abnormally activated, are critical for the formation and progression of tumors, fibrosis and other diseases. MEK inhibitors block phosphorylation (activation) of extracellular signal-regulated kinases (ERK). Blocking the phosphorylation of ERK can lead to cell death and inhibition of tumor growth. Existing FDA approved MEK inhibitors are marketed for a range of diseases, including certain cancers and NF1. We believe these MEK inhibitors suffer from certain limitations, including known toxicities. Unlike current FDA approved MEK inhibitors, PAS-004 is macrocyclic, which we believe may lead to improved pharmacokinetic and safety (tolerability) profiles. Cyclization offers rigidity for stronger binding with drug target receptors. PAS-004 was designed to provide a longer half-life with what we believe is a better therapeutic window. Further, we believe the potency and safety profile that PAS-004 has demonstrated in preclinical studies may also lead to stronger and more durable response rates and efficacy, as well as better dosing schedules, which may not require the fasting or dietary restrictions of approved MEK inhibitors. PAS-004 has been tested in a range of mouse models of various diseases and has completed preclinical testing and animal toxicology studies to support an IND application with the FDA that we plan to submit in the third quarter of 2023. Additionally, PAS-004 has received orphan-drug designation from the FDA for the treatment of NF1.

About Pasithea Therapeutics Corp.

Pasithea Therapeutics is a biotechnology company primarily focused on the discovery, research and development of innovative treatments for central nervous system (CNS) disorders and RASopathies. With an experienced team of experts in the fields of neuroscience, translational medicine, and drug development, Pasithea is developing new molecular entities for the treatment of neurological disorders, including Neurofibromatosis type 1 (NF1), Amyotrophic Lateral Sclerosis (ALS) and Multiple Sclerosis (MS).

Forward Looking Statements

This press release contains statements that constitute “forward-looking statements.” Forward-looking statements are subject to numerous conditions, many of which are beyond the control of the Company. While the Company believes these forward-looking statements are reasonable, undue reliance should not be placed on any such forward-looking statements, which are based on information available to the Company on the date of this release. These forward-looking statements are based upon current estimates and assumptions and are subject to various risks and uncertainties, including, without limitation, those set forth in the Company’s filings with the U.S. Securities and Exchange Commission (SEC). Thus, actual results could be materially different. The Company undertakes no obligation to update these statements whether as a result of new information, future events or otherwise, after the date of this release, except as required by law.

Contact

Patrick Gaynes

Corporate Communications



EN
01/06/2023

Underlying

To request access to management, click here to engage with our
partner Phoenix-IR's CorporateAccessNetwork.com

Reports on PASITHEA THERAPEUTICS CORP

 PRESS RELEASE

Pasithea Therapeutics Completes Enrollment and Initial Dosing of First...

Pasithea Therapeutics Completes Enrollment and Initial Dosing of First Cohort from its Phase 1/1b Clinical Trial of PAS-004 in Adult NF1 Patients – Initial interim safety, tolerability, biomarker, and preliminary efficacy data expected in Q1 2026 – MIAMI, July 31, 2025 (GLOBE NEWSWIRE) -- (NASDAQ: KTTA) (“Pasithea” or the “Company”), a clinical-stage biotechnology company developing PAS-004, a next-generation macrocyclic MEK inhibitor for the treatment of neurofibromatosis type 1 (NF1) and other MAPK pathway driven indications, today announced the Company has completed enrollment and i...

 PRESS RELEASE

Pasithea Therapeutics Appoints Expert in ETS2-driven Inflammatory Dise...

Pasithea Therapeutics Appoints Expert in ETS2-driven Inflammatory Disease to Scientific Advisory Board Dr. James Lee of the Francis Crick Institute will help guide development of PAS-004 for ETS2-driven diseases such as inflammatory bowel disease (IBD) MIAMI, June 11, 2025 (GLOBE NEWSWIRE) -- (NASDAQ: KTTA) (“Pasithea” or the “Company”), a clinical-stage biotechnology company developing PAS-004, a next-generation macrocyclic MEK inhibitor, today announced the appointment of Dr. James Lee to its scientific advisory board (SAB) to help guide development of PAS-004 for the treatment of ET...

 PRESS RELEASE

Pasithea Therapeutics Presents Updated Interim Data from Ongoing Phase...

Pasithea Therapeutics Presents Updated Interim Data from Ongoing Phase 1 Study of PAS-004 at the ASCO Annual Meeting 2025 -- PAS-004 demonstrates preliminary clinical activity as a monotherapy in patients with heavily pre-treated, refractory solid tumors -- -- One patient in cohort 4A (15mg capsule) with stage 4 BRAF-mutated melanoma, who had progressed after two prior lines of therapy, including a prior MEK inhibitor + BRAF inhibitor combination therapy, achieves over 5 months of stable disease with tumor volume reduction of -14.9% and remains on treatment -- -- PAS-004 pharmacokinet...

 PRESS RELEASE

Pasithea Therapeutics Announces Preclinical Data that Shows PAS-004 In...

Pasithea Therapeutics Announces Preclinical Data that Shows PAS-004 Inhibits ETS2 Signaling, a Key Driver of Inflammation in IBD and Other Large Addressable Market Diseases -- Demonstrates PAS-004’s potential as a differentiated MEK inhibitor for immune-mediated inflammatory diseases such as IBD and ankylosing spondylitis – -- Positions PAS-004 for potential expansion beyond MAPK pathway driven tumors into inflammatory diseases – -- PAS-004 outperforms FDA-approved MEK inhibitor selumetinib in targeting ETS2 pathway – -- Study conducted at Francis Crick Institute by lead author of 2024 N...

 PRESS RELEASE

Pasithea Therapeutics Announces Initiation of Phase 1/1B Study of PAS-...

Pasithea Therapeutics Announces Initiation of Phase 1/1B Study of PAS-004 in Adult NF1 Patients and Activation of First Clinical Trial Site -- First patient expected to be dosed during Q2 2025 ---- Trial will evaluate safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy in both plexiform neurofibromas and cutaneous neurofibromas ---- Starting dose of 4mg tablet QD (once daily) ---- First trial site in Australia. Four additional sites planned for Australia, South Korea, and U.S. –-- Australian R&D Tax Incentive refund of up to 48.5% of eligible study-related cos...

ResearchPool Subscriptions

Get the most out of your insights

Get in touch