Product Pipeline

Our Goal is to make a Significant Impact on Metabolic Diseases

Poxel is a dynamic biopharmaceutical company that uses its extensive expertise in developing innovative drugs for metabolic diseases, with a focus on type 2 diabetes and non-alcoholic steatohepatitis (NASH). In our mid-to-late stage pipeline, we are currently advancing three drug candidates as well as earlier-stage opportunities from our AMPK activation and TZD platforms.

Type 2 Diabetes

Imeglimin, Poxel’s first-in-class lead product, targets mitochondrial dysfunction. Together, with our partner Sumitomo Dainippon Pharma, we have successfully completed the Phase 3 TIMES program for the treatment of type 2 diabetes in Japan. A New Drug Application in Japan (J-NDA) is currently advancing through regulatory review with our partner Sumitomo Dainippon Pharma, and a target product launch is anticipated in fiscal year 2021 (Sumitomo Dainippon Pharma’s fiscal year, from April 2021 to March 2022).

In the US, Europe, and other countries not covered by the partnership with Sumitomo Dainippon Pharma, Poxel will regain Imeglimin rights, effective January 31, 2021 and is considering various options to advance Imeglimin in those countries.

NASH

PXL770, a first-in-class direct adenosine monophosphate-activated protein kinase (AMPK) activator, is in 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) inhibitor, is advancing into a Phase 2 clinical trial for the treatment of NASH.

Poxel also has additional earlier-stage programs targeting metabolic, specialty and rare diseases. The Company intends to generate further growth through strategic partnerships.


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Imeglimin

Imeglimin is a new chemical substance classified as a tetrahydrotriazine compound, and the first clinical candidate in a chemical class. 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 pancreas, muscles, and the liver, 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.

Japan/Asia

In Japan, China and 11 other East and Southeast Asian countries, Sumitomo Dainippon Pharma is our strategic partner for Imeglimin. For Japan, Poxel and Sumitomo Dainippon Pharma have successfully completed the Phase 3 TIMES program for Imeglimin in over 1,110 patients. A New Drug Application in Japan (J-NDA) is currently advancing through regulatory review with our partner Sumitomo Dainippon Pharma, and a target product launch is anticipated in fiscal year 2021 (Sumitomo Dainippon Pharma’s fiscal year, from April 2021 to March 2022). The TIMES program was funded by Sumitomo Dainippon Pharma, and they will commercialize the product for this market. In China, South Korea, Taiwan and nine other Southeast Asian countries including Indonesia, Vietnam, Thailand, Malaysia, the Philippines, Singapore, Myanmar, Cambodia, and Laos, Sumitomo Dainippon Pharma will be solely responsible for the development and commercialization of Imeglimin.

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U.S. and Europe

In the US, Europe, and other countries not covered by the partnership with Sumitomo Dainippon Pharma, Poxel will regain Imeglimin rights, effective January 31, 2021 and is considering various options to advance Imeglimin in those countries.

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PXL770

PXL770 is a first-in-class direct AMPK activator. AMPK is a central regulator of multiple metabolic pathways leading to the control of lipid metabolism, glucose homeostasis and inflammation. Based on its central metabolic role, targeting AMPK offers the opportunity to pursue a wide range of indications to treat chronic metabolic diseases, including diseases that affect the liver, such as NASH.

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PXL065 (DRX-065)

PXL065 is deuterium-stabilized R-pioglitazone. Although pioglitazone is not approved by the FDA for the treatment of NASH, it is the most extensively studied drug for NASH and has demonstrated “resolution of NASH without worsening of fibrosis” in a Phase 4 trial. Pioglitazone is the only drug recommended for biopsy-proven NASH patients by the Practice Guidelines published by the American Association for the Study of Liver Diseases (AASLD) and the European Association for the Study of the Liver (EASL). Pioglitazone’s off-label use for NASH, however, has been limited due to the PPARγ-related side effects, which include weight gain, bone fractures and fluid retention.

Pioglitazone is a 1:1 mixture of two mirror-image compounds (R- and S-stereoisomers) that interconvert in vivo. Using deuterium, we stabilized each stereoisomer and characterized their different pharmacological properties. In in vitro studies, PXL065 has been shown to target MPC as an inhibitor. In preclinical animal models, PXL065 exhibits the anti-inflammatory and NASH activity associated with pioglitazone with little or no weight gain or fluid retention, side effects which are associated with the S-stereoisomer. Based upon preclinical and Phase 1 results to date, We believe that PXL065 may have a better therapeutic profile than pioglitazone for NASH.

PXL007 (EYP001)

We have a licensing agreement with Enyo Pharma for our FXR (farnesoid X receptor) agonist. Enyo has completed a Phase 1 study and they are currently conducting Phase 2 trials in Hepatitis B and NASH.

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Additional Pipeline Opportunities

Preclinical studies are underway to assess the combination potential of PXL770 and PXL065 with other agents in development for the treatment of NASH. Furthermore, preclinical studies are ongoing to evaluate our adenosine monophosphate-activated protein kinase (AMPK) activation and TZD platforms in additional chronic and rare-orphan metabolic diseases.

Publications

Review our scientific publications, as well as posters and presentations.

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