- Results of PXL065 Phase 2 (DESTINY-1) trial in NASH expected in Q3 2022
LYON, France--(BUSINESS WIRE)-- POXEL SA (Euronext: POXEL - FR0012432516), a clinical stage biopharmaceutical company developing innovative treatments for serious chronic diseases with metabolic pathophysiology, including non-alcoholic steatohepatitis (NASH) and rare metabolic disorders, announced today that the U.S. Patent and Trademark Office (PTO) has issued to Poxel US Patent No. 11319313 which represents a new patent for PXL065, a novel, proprietary deuterium-stabilized R-stereoisomer of pioglitazone. The new patent describes a specific form of PXL065 with unique properties. Importantly, this recently issued patent provides additional protection through 2041 and could expand protection for PXL065 worldwide, with the potential for an additional 5 years through patent term extension.
Poxel CEO, Thomas Kuhn, commented: “We are pleased that our continuing efforts to enhance our patent portfolio has resulted in this successful addition of a key patent to our intellectual property. This new patent for PXL065 extends exclusivity, and we are also prosecuting the related patent applications globally. We also look forward to reporting Phase 2 DESTINY-1 topline results for PXL065 in NASH expected in the third quarter.”
Acquired in 2018, pursuant to a strategic agreement with DeuteRx, PXL065 is the deuterated-stabilized R stereoisomer (single R-isomer) of pioglitazone, its parent molecule. It is currently being evaluated in a Phase 2 study (DESTINY-1) for NASH, with results expected in Q3 2022, and will be evaluated in a Phase 2a biomarker proof-of-concept (POC) clinical trial for adrenoleukodystrophy (ALD), which is prepared to initiate as soon as possible, subject to additional financing.
About Poxel SA
Poxel is a clinical stage biopharmaceutical company developing innovative treatments for chronic serious diseases with metabolic pathophysiology, including non-alcoholic steatohepatitis (NASH) and rare disorders. Poxel has clinical and earlier-stage programs from its adenosine monophosphate-activated protein kinase (AMPK) activator and deuterated TZD platforms targeting chronic and rare metabolic diseases. For the treatment of NASH, PXL065 (deuterium-stabilized R-pioglitazone) is in a streamlined Phase 2 trial (DESTINY-1). PXL770, a first-in-class direct AMPK activator, has successfully completed a Phase 2a proof-of-concept trial for the treatment of NASH, which met its objectives. For the rare inherited metabolic disorder, adrenoleukodystrophy (ALD), the company intends to initiate Phase 2a proof of concept studies with PXL065 and PXL770 in patients with adrenomyeloneuropathy (AMN). TWYMEEG® (Imeglimin), Poxel’s first-in-class lead product that targets mitochondrial dysfunction, has been approved and launched for the treatment of type 2 diabetes in Japan. Poxel expects to receive royalties and sales-based payments from Sumitomo Pharma. Poxel has a strategic partnership with Sumitomo Pharma for Imeglimin in Japan, China, South Korea, Taiwan and nine other Southeast Asian countries. The Company intends to generate further growth through strategic partnerships and pipeline development. Listed on Euronext Paris, Poxel is headquartered in Lyon, France, and has subsidiaries in Boston, MA, and Tokyo, Japan.
For more information, please visit: www.poxelpharma.com
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Source: Poxel SA
Released June 9, 2022