Company: Zydus Cadila
Drug name: Saroglitazar
Mechanism: PPAR alpha and gamma dual agonist
Stage: Phase 2
Next step: Potential phase 3 study in NASH
Zydus’ saroglitazar is approved in India to treat hypertriglyceridemia—high triglyceride levels—in patients with Type 2 diabetes. In a study presented at this year’s American Association for the Study of Liver Diseases meeting, the company tested three doses of the drug against placebo in patients with nonalcoholic fatty liver disease and/or NASH who were also overweight.
The drug didn’t move the needle on patients’ weight, but after 16 weeks of treatment, all three doses of saroglitazar—1 mg, 2 mg and 4 mg—beat placebo at lowering liver enzyme levels. The highest dose significantly lowered patients’ insulin resistance, as well as their triglyceride and cholesterol levels. The study also found that of the patients taking the highest dose, 41% had 30% less liver fat after treatment. Just 8% in the placebo group saw that much fat loss.
Like Genfit's elafibranor, saroglitazar works by targeting two PPAR receptors, a type of protein found inside cells that plays a role in cellular metabolism. The phase 2 failure of another PPAR agonist raised some questions about the viability of this class of drugs. But Cymabay's seladelpar only targeted the delta form of PPAR, while saroglitazar hits the alpha and gamma forms. And Zydus is pretty bullish on its drug; the company filed saroglitazar for Indian approval in NASH just last week.