Poxel announces Phase 1 initiation of EYP001 for the treatment of chronic hepatitis B

Lyon, France, December 19, 2016 – POXEL SA (Euronext – POXEL – FR0012432516), a biopharmaceutical company focused on the development of innovative treatments for type 2 diabetes, announced that ENYO Pharma SA reported that they have initiated a Phase 1 program for EYP001, an FXR agonist that was licensed to ENYO Pharma from Poxel.

According to ENYO Pharma, the Phase 1a single and multiple ascending dose trial evaluating EYP001 in healthy subjects has been initiated, and the single dose escalation has been completed. ENYO Pharma stated that the results have shown that EYP001 was safe and well-tolerated at all doses studied in 46 healthy subjects. The safety and pharmacokinetics (PK) analysis of these first Phase 1 data are on track for completion in Q2 2017.

“The licensing agreement with ENYO Pharma demonstrates the leverage we are seeing with our portfolio. We are pleased that EYP001 has successfully advanced in the clinic and we look forward to further results in 2017,” said Thomas Kuhn, CEO of Poxel. “Through the licensing agreement that Poxel has with ENYO for EYP001, Poxel is entitled to receive milestone payments as EYP001 advances through development and royalties from sales.”

EYP001 is a synthetic farnesoid X receptor (FXR) agonist with a favorable profile for oral therapy. The first Phase 1 study was designed to determine the safety, tolerability and pharmacokinetics of EYP001 in healthy subjects.

ENYO Pharma also announced that the next phase of the Phase 1 clinical program of EYP001 is anticipated to begin in 2017 and will test the safety, PK and initial antiviral activity of EYP001 in subjects with chronic hepatitis B virus infection.

About EYP001

ENYO Pharma SA has licensed a family of FXR agonists from Poxel SA and holds worldwide exclusive rights on these patented compounds. EYP001 is a small non-bile acid molecule, acting on the host target nuclear receptor FXR, and is developed for the oral administration in patients with Chronic Hepatitis B (CHB). FXR is a novel and promising drug target with multiple activities required for viral replication and persistence. EYP001 interferes with HBV replication in the liver at post-entry steps likely impacting transcriptional activity of cccDNA. Activation of FXR function by EYP001 offers the potential for more efficient suppression of the virus leading to improved, durable viral suppression and cure rates.

About Poxel SA

Poxel uses its development expertise in metabolism to advance a pipeline of drug candidates focused on the treatment of type 2 diabetes. We have successfully completed our Phase 2 clinical program for our first-in-class lead product, Imeglimin, which targets mitochondrial dysfunction, in the U.S. and EU and have fully enrolled a Phase 2b clinical study in Japan. Our second program, PXL770, a direct AMPK activator, is in Phase 1 development. We intend to generate further growth through strategic partnerships and pipeline development. (Euronext: POXEL, www.poxel.com)

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