- The results of the Phase II (DESTINY-1) study for PXL065 in NASH are expected in the third quarter of 2022
LYON, France – (BUSINESS WIRE) – Regulatory reports:
The company POXEL SA (Euronext: POXEL – FR0012432516), a clinical-based biopharmaceutical company developing innovative treatments for serious chronic diseases with metabolic pathophysiology, including non-alcoholic steatohepatitis (NASH) and rare metabolic diseases, announces today that the United States Patent and Trademark Office (US Patent and Trademark Office – PTO) issued to Poxel U.S. Pat. 11319313, which represents a new patent for PXL065, a new R-stereoisomer of pioglitazone stabilized by deuterium substitution. This new patent describes a specific form of PXL065 with unique properties. In addition, PXL065 provides additional protection until 2041 with international coverage and potential patent renewal for another 5 years.
Poxel CEO Thomas Kuhn said: We are pleased that our continued efforts to strengthen our patent portfolio have resulted in the addition of this key new patent protection for PXL065. This new patent extends the exclusivity of PXL065 and we have also filed patent applications to extend it worldwide. We are also looking forward to reporting on the top results of the DESTINY-1 Phase II study for PXL065 at NASH, which is expected in the third quarter. “.
PXL065, obtained in 2018 under a strategic agreement with DeuteRx, is the R stereoisomer of pioglitazone, its parent molecule, stabilized by deuterium substitution. It is currently being evaluated in a phase 2 (DESTINY-1) study for NASH, with results expected in the third quarter of 2022, and will be evaluated in a Phase IIa Adrenoleukodystrophy (ALD) Phase II Verification Clinical Study, which will be launched as soon as possible. , provided that additional funding is provided.
About Poxel AG
Poxel is a dynamic biopharmaceutical company which relies on its expertise for development innovative ways of treating metabolic diseasesof which non – alcoholic steatohepatitis (NASH) and some rare diseases. The company currently has clinical programs and early-stage development capabilities thanks to adenosine monophosphate activated protein kinase (AMPK) activator platforms and deuterated thiazolidinedione (TDZ) molecular platforms for the treatment of chronic and rare metabolic diseases. For the treatment of NASH, PXL065 (R-pioglitazone stabilized by deuterium substitution) is evaluated in a phase II study (DESTINY-1). a PXL770, a first-class direct activator of adenosine monophosphate-activated protein kinase (AMPK), has successfully completed a phase IIa concept validation study for the treatment of NASH, thereby meeting its objectives. In the field of adrenoleukodystrophy (ALD), a rare inherited metabolic disease, the company intends to initiate a phase IIa validation study with PXL065 and PXL770 in patients with adrenomyeloneuropathy (AMN). TWYMEEG® (Imeglimin), Poxel’s flagship product and the first in its class of drugs to address mitochondrial dysfunction, has been approved in Japan and is marketed for the treatment of type 2 diabetes. Poxel expects to receive royalties and sales-based payments. Sumitomo Pharma is Poxel’s strategic partner for Imeglimin in Japan, China, South Korea, Taiwan and nine other Southeast Asian countries. The company intends to continue its development through a proactive strategic partnership policy and the development of its drug candidate portfolio. Poxel is listed on Euronext Paris, is headquartered in Lyon, France, and has subsidiaries in Boston, United States and Tokyo, Japan.
For more information, visit: www.poxelpharma.com
All statements other than historical statements in this press release regarding future events are subject to (i) changes without notice and (ii) factors beyond the Company’s control. Such statements may include, but are not limited to, any statement that precedes, follows, or includes words such as “goal,” “believe,” “expect,” “target,” “intend,” “may,” to expect”. , estimate Forward-looking statements are subject to inherent risks and uncertainties beyond the Company’s control that could cause the Company’s actual results or performance to differ materially from those expressed or anticipated in such statements.
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