Poxel Announces Completion of Patient Enrollment for TIMES 2 Trial in Phase 3 Registration Program for Imeglimin, an Investigational Therapeutic Agent for Type 2 Diabetes, in Japan

POXEL SA (Euronext – POXEL - FR0012432516), a biopharmaceutical company focused on the development of innovative treatments for metabolic diseases, including type 2 diabetes and non-alcoholic steatohepatitis (NASH), announced today that patient enrollment has been completed in the TIMES 2 trial of the Phase 3 registration program for Imeglimin, an investigational therapeutic agent for type 2 diabetes, in Japan. Referred to as TIMES (Trials of IMeglimin for Efficacy and Safety), the Imeglimin Phase 3 registration program in Japan includes three pivotal trials to evaluate the efficacy and safety of Imeglimin in over 1,100 patients. The TIMES 2 trial is a 52-week, open-label, parallel-group study to assess the long-term safety and efficacy of Imeglimin in Japanese patients with type 2 diabetes. In this trial, Imeglimin is administrated as a monotherapy or combination therapy to over 700 patients with existing hypoglycemic agents, including a DPP4 inhibitor, SGLT2 inhibitor, biguanide, sulphonylurea and GLP1 receptor agonist.

"In less than one year after signing the strategic partnership with Sumitomo Dainippon Pharma, we have made substantial progress advancing all three pivotal Phase 3 TIMES trials for Imeglimin in Japan. This achievement is a direct result of our close collaboration with Sumitomo Dainippon Pharma. We remain on track for the TIMES 1 data results in the second quarter of 2019 and the TIMES 2 and TIMES 3 data results are anticipated in the second half of 2019,” said Thomas Kuhn, CEO of Poxel. "In addition to advancing the Imeglimin Phase 3 program in Japan, we have recently established a subsidiary and expanded our team with the appointment of Takashi Kaneko, MD, PhD, as Senior Vice President Medical and President of Poxel Japan K.K.”

"I am very pleased to report that the execution of the TIMES program, which is being led by Poxel, has continued to progress in a very timely manner and we have now completed enrollment of all three Phase 3 pivotal studies, which includes over 1,100 patients,” said Christophe Arbet-Engels, MD, PhD, Chief Medical Officer, Executive Vice President, Late Development and Medical Affairs of Poxel. "We are committed to the successful completion of the TIMES program and will continue to closely collaborate with our colleagues at Sumitomo Dainippon Pharma to support the Japanese New Drug Application submission anticipated in 2020. Our near-term goal in Japan is to provide patients with a new, innovative therapeutic option for type 2 diabetes.”

The TIMES program is a joint development effort between Poxel and Sumitomo Dainippon Pharma. The companies entered into a strategic partnership in October 2017 for the development and commercialization of Imeglimin in Japan, China, South Korea, Taiwan and nine other Southeast and East Asian countries.²

Imeglimin is an orally-available drug candidate with a novel mechanism of action that has been observed in clinical studies to demonstrate glucose lowering benefits by simultaneously targeting all three key organs which play an important role in the treatment of type 2 diabetes: the liver, muscles and the pancreas. Imeglimin has demonstrated in preclinical studies the potential to address mitochondrial dysfunction, which is believed to be at the core of type 2 diabetes pathophysiology. Imeglimin has completed Phase 1 and Phase 2 development in over 1,200 subjects in the U.S., Europe and Japan.

About the TIMES Program
TIMES (Trials of Imeglimin for Efficacy and Safety), the Phase 3 program for Imeglimin for the treatment of type 2 diabetes in Japan, consists of three pivotal trials involving over 1,100 patients. The TIMES program includes the following three trials that will be performed using the dose of 1,000 mg twice daily:

TIMES 1: A Phase 3, 24-week, double-blind placebo-controlled, randomized, monotherapy study to assess the efficacy, safety and tolerability of Imeglimin in Japanese patients with type 2 diabetes, using the change in HbA1c as the primary endpoint. Secondary endpoints of the trial will include other standard glycemic and non-glycemic parameters.

TIMES 2: A Phase 3, 52-week, open-label, parallel-group study to assess the long-term safety and efficacy of Imeglimin in Japanese patients with type 2 diabetes. In this study, Imeglimin will be administrated orally as a monotherapy or combination therapy with existing hypoglycemic agents, including a DPP4 inhibitor, SGLT2 inhibitor, biguanide, sulphonylurea and GLP1 receptor agonist.

TIMES 3: A Phase 3, 16-week, double-blind, placebo-controlled, randomized study with a 36-week open-label extension period to evaluate the efficacy and safety of Imeglimin in combination with insulin in Japanese patients with type 2 diabetes and inadequate glycemic control on insulin therapy.

About Imeglimin
Imeglimin is the first clinical candidate in a new chemical class of oral agents called Glimins by the World Health Organization. Imeglimin has a unique mechanism of action ("MOA”) that targets mitochondrial bioenergetics. Imeglimin acts on all three key organs which play an important role in the treatment of type 2 diabetes: the liver, muscles and the pancreas, and it has demonstrated glucose lowering benefits by increasing insulin secretion in response to glucose, improving insulin sensitivity and suppressing gluconeogenesis. This MOA has the potential to prevent endothelial and diastolic dysfunction, which can provide protective effects on micro- and macro-vascular defects induced by diabetes. It also has the potential for protective effect on beta-cell survival and function. This unique MOA offers the potential opportunity for Imeglimin to be a candidate for the treatment of type 2 diabetes in almost all stages of the current anti-diabetic treatment paradigm, including monotherapy or as an add-on to other glucose lowering therapies.

About Poxel SA
Poxel uses its development expertise in metabolism to advance a pipeline of drug candidates focused on the treatment of metabolic disorders, including type 2 diabetes and non-alcoholic steatohepatitis (NASH). We have successfully completed the Phase 2 clinical program for our first-in-class lead product, Imeglimin, which targets mitochondrial dysfunction, in the U.S., Europe and Japan. Together, with our partner Sumitomo Dainippon Pharma, we are conducting the Phase 3 Trials of IMeglimin for Efficacy and Safety (TIMES) program for the treatment of type 2 diabetes in Japan. Our partner Roivant Sciences is responsible for Imeglimin’s development and commercialization in countries outside of Poxel’s partnership with Sumitomo Dainippon Pharma, including the U.S. and Europe. PXL770, a first in class direct adenosine monophosphate-activated protein kinase (AMPK) activator, is advancing into a Phase 2a proof-of-concept program for the treatment of NASH. PXL770 could also have the potential to treat additional metabolic diseases. PXL065 (deuterium-stabilized R-pioglitazone), a mitochondrial pyruvate carrier (MPC), is in Phase 1 and being developed for the treatment of NASH. Poxel also has additional earlier-stage programs, including deuterated drug candidates for metabolic, specialty and rare diseases. We intend to generate further growth through strategic partnerships and pipeline development. (Euronext: POXEL, www.poxelpharma.com)

¹Source: Oppenheimer & Co. estimates.
²including: Indonesia, Vietnam, Thailand, Malaysia, The Philippines, Singapore, Republic of the Union of Myanmar, Kingdom of Cambodia and Lao People's Democratic Republic.

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