Poxel Announces New Solid Form Patent for PXL065 that Provides Additional Protection through 2041
09 Giugno 2022 - 7:30AM
Business Wire
- Results of PXL065 Phase 2 (DESTINY-1) trial in NASH expected
in Q3 2022
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
All statements other than statements of historical fact included
in this press release about future events are subject to (i) change
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and other words and terms of similar meaning or the negative
thereof. 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 be materially different
from the expected results or performance expressed or implied by
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Investor relations / Media
Aurélie Bozza Investor Relations & Communication Senior
Director aurelie.bozza@poxelpharma.com +33 6 99 81 08 36
Elizabeth Woo Senior Vice President, Investor Relations &
Communication elizabeth.woo@poxelpharma.com
NewCap Emmanuel Huynh or Arthur Rouillé poxel@newcap.eu +33 1 44
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