Pleco Therapeutics B.V.

Pleco Therapeutics Announces Positive Outcome of Pre-IND meeting with FDA for PTX-252 in Acute Myeloid Leukaemia

NIJMEGEN, The Netherlands, March 26, 2025 (GLOBE NEWSWIRE) -- Pleco Therapeutics, a clinical-stage biopharmaceutical company developing novel therapies for difficult-to-treat cancers, announces a positive outcome from its Pre-Investigational New Drug (Pre-IND) meeting with the U.S. Food and Drug Administration (FDA). The meeting addressed the continued development of PTX-252, an intravenous (IV) formulation designed to treat patients with Acute Myeloid Leukaemia (AML).

The pre-IND meeting provided an opportunity for the Company to discuss its Investigational New Drug (IND) development plan and receive FDA guidance on nonclinical and clinical study requirements for its new drug candidate PTX-252. In the written response from the Division of Hematologic Malignancies, the FDA provided constructive feedback and expressed support for Pleco’s proposed development strategy.

PTX-252 is a small molecule designed to remove toxic heavy metals from the tumour microenvironment, improving the functioning of the tumour suppressor protein p53, thus increasing the sensitivity of cancer cells to chemotherapy. The compound has been granted Orphan Drug Designation by the FDA for the treatment in AML.

“The FDA’s constructive feedback supports our mission to bring PTX-252 to cancer patients with limited treatment options,” says Ivo Timmermans, Founder and co-CEO of Pleco Therapeutics. “The guidance provides a clear path forward to opening the IND to advance PTX-252 into the clinic as swiftly as possible.”

Michael Stalhamer, President Pleco Therapeutics USA: “Collaborating with the US FDA and other Regulatory Bodies early in the development of a medicinal product is a key step. Pleco Therapeutics is grateful for the feedback which helps to define and streamline our clinical development program, while ensuring a safe and effective regulatory pathway to patients.”

Pleco is co-developing PTX-252 with Belgian based specialty pharma company Hyloris Pharmaceuticals.

About Pleco Therapeutics

Pleco Therapeutics is a clinical stage specialty biopharmaceutical company that aims to improve the survival rate of cancer patients through its novel Plecoid™ therapies that increase the effectiveness of current cancer treatments. Pleco is headquartered in the Netherlands, with a U.S. subsidiary in Raleigh, North Carolina. www.plecotherapeutics.com.

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Pleco Therapeutics
Email: julie.powell@plecotherapeutics.com
Website: www.plecotherapeutics.com