POXEL SA announced a new strategic direction to focus its pipeline on high value, rare metabolic indications and NASH, with the goal of creating pipeline synergies, maximizing resources, and driving shareholder value. Based on results from the ongoing PXL065 DESTINY Phase 2 NASH trial and the planned Phase 2a POC biomarker studies for PXL065 and PXL770 in ALD, the Company intends to select one program, either PXL065 or PXL770, to advance in NASH and one program to advance in ALD. In parallel with the Company’s efforts in ALD, another important goal is to launch an additional rare disease development program in 2022. The Company believes that this strategy will expand the addressable market opportunity for its development programs and offers stakeholders a more diversified clinical pipeline. As a result of the review process and portfolio prioritization, the Company is announcing the following clinical development program updates: In ALD, Phase 2a clinical POC biomarker studies of PXL065 and PXL770 are planned to initiate in early 2022, with data expected by year end 2022. The initial focus will be on patients with adrenomyeloneuropathy (AMN), the large subtype of ALD. Two identical studies will enroll adult male AMN patients and assess the effect of PXL065 and PXL770 over 12 weeks of treatment on pharmacokinetics, safety, and efficacy using relevant biomarkers, including the impact on elevated very long-chain fatty acids (VLCFA), the hallmark plasma marker of disease. In NASH, PXL065, deuterium-stabilized R-pioglitazone, is in a streamlined Phase 2 trial (DESTINY). Patient screening is finished and enrollment is now expected to complete in Third Quarter 2021, with topline data anticipated approximately one year later. This Phase 2 36-week trial in noncirrhotic biopsy-proven NASH patients will assess three doses of PXL065 compared to placebo in at least 120 patients. The results of this trial will be used to help identify the dose or doses for a Phase 3 registration trial. Initiation of the NASH Phase 2b trial for PXL770, a first-in-class, oral direct AMPK activator, will be postponed, pending results from the ongoing PXL065 Phase 2 trial in NASH and both Phase 2a POC biomarker studies in AMN. In the STAMP-NAFLD Phase 2a trial, completed at the end of 2020, PXL770 was observed to produce significant improvements in liver fat content and liver enzymes with a greater response in patients with co-existing Type 2 diabetes mellitus (T2DM); in these patients, additional improvements in glycemia were observed. PXL770 was observed to be safe and well tolerated.