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PXL065 is a novel, proprietary deuterium-stabilized R-pioglitazone. PXL065 was observed to be safe and well tolerated with no dose-dependent increase in body weight and no increased lower extremity edema vs. placebo.
Lead Product(s):
Deuterium Stabilized (R)‐Pioglitazone
PXL065 (deuterated pioglitazone) Phase 2 trial for the treatment of NASH met its primary efficacy endpoint for liver fat content reduction at 36-weeks for all doses.
Lead Product(s):
Deuterium Stabilized (R)‐Pioglitazone
IVA337 (lanifibranor), orally-available small molecule that acts to induce anti-fibrotic, anti-inflammatory, beneficial vascular and metabolic changes in body by activating all PPAR isoforms, which are well‑characterized nuclear receptor proteins that regulate gene expression.
Lanifibranor, a pan-PPAR agonist, improves markers of cardiometabolic health in patients with NASH, has demonstrated beneficial effects on liver histology, NASH resolution and fibrosis improvement in patients.
Phase IIb has demonstrated that IVA337 (lanifibranor) as a monotherapy could not only resolve NASH and improve fibrosis but also improve lipids and glycemic profiles, in combination with empagliflozin provide additional benefits and further improve cardiometabolic risk profile.
IVA337 (lanifibranor) is next generation pan-PPAR (peroxisome proliferator-activated receptors) agonist addressing pathophysiology of NASH (Non-alcoholic steatohepatitis) or in the treatment of, liver steatosis and moderate to severe necroinflammation without cirrhosis.
The results showed that treatment with PXL770 at 500 mg QD resulted in significant reductions in mean liver fat content and alanine transaminase (ALT) levels (vs. baseline).
GENFIT is launching a clinical program with nitazoxanide (NTZ) in this disease. A Phase 1 study to evaluate pharmacokinetics and pharmacodynamics in patients with varying degrees of hepatic impairment is expected to start in 4Q21 with clinical data expected end of 2022.
The Phase 1 study Showed that setanaxib is well tolerated at the doses tested, with no safety signal or dose-limiting toxicity being identified. The study assessed the safety and pharmacokinetics of oral setanaxib at select doses in 46 healthy adult male and female subjects.
Analysis of results from the Phase 1b study of PXL065 (deuterium-stabilized R-pioglitazone) predicts efficacy at 15 mg once-daily is equivalent to 45 mg Actos®*, with little to no PPARg-related side effects, such as weight gain.
Lead Product(s):
Deuterium-stabilized R-pioglitazone