Poxel obtains an FDA ‘Fast Track’











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(Boursier.com) — poxels announces that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation (FTD) to PXL770 for the treatment of patients with adrenomyeloneuropathy (AMN), the most common form of X-linked adrenoleukodystrophy (ALD). PXL770 is a new direct activator of adenosine monophosphate-activated protein kinase (AMPK), for which the initiation of a phase IIa proof-of-concept (POC) clinical study is planned in the middle of the year, under reserve of additional funding.

Thomas Kuhn, Chief Executive Officer of Poxel said: “FDA’s granting of Fast Track status to PXL770, shortly after granting it to PXL065, another of our very promising products, is a strong recognition the potential of our two programs in adrenoleukodystrophy, a disease for which there is currently no treatment Poxel is working to develop innovative treatments to improve the lives of patients with serious and rare chronic diseases with metabolic pathophysiology, and Fast Track status could significantly accelerate the time to approval of PXL770 in ALD.We are already working on the next steps, including the preparation of our two Phase 2a clinical studies that we plan to carry out. ‘initiate in the middle of the year with results expected in early 2023’.

Fast Track status is designed to accelerate the development of drugs that have demonstrated the potential to address unmet medical needs related to serious or life-threatening conditions. For Poxel, the Fast Track status will strengthen its access to the FDA, including through meetings and written exchanges throughout the development of PXL065. Medicines with this status are eligible for an accelerated authorization procedure and a priority review when submitting a New Drug Application (NDA), which may allow authorization faster product to market. This status also allows for a continuous review, which involves submitting sections of the registration application for a new medicine on the fly, rather than a complete application at the end of its development… The launch of the phase IIa proof-of-concept (POC) clinical study for PXL770 and PXL065 in X-linked adrenoleukodystrophy (ALD) is scheduled for mid-year, subject to additional funding, with results expected early 2023.


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