Zydus Cadila completes enrolment for Saroglitazar Mg trials

Zydus Cadila has announced the completion of enrolment in Evidences II, Evidences III and Evidences V Phase 3 clinical trials of Saroglitazar Mg for treating Non-Alcoholic SteatoHepatitis (NASH).

Patients with NASH have been enrolled in these trials across clinical sites in India and Mexico. The company’s management has informed that Saroglitazar Mg is being evaluated in over 23 different controlled clinical trials involving over 3,800 patients. NASH is an area of unmet healthcare need and a tested therapy is required for millions of patients suffering from this deadly disease.

Saroglitazar Magnesium was launched in India during September 2013 for the treatment of hypertriglyceridemia and diabetic dyslipidemia in patients with type-2 diabetes not controlled by statins. Saroglitazar Mg has demonstrated beneficial effects in NASH animal models. Saroglitazar Mg favourably affects all components of NASH including steatosis, ballooning, inflammation and fibrosis in NASH models. Saroglitazar Mg has previously demonstrated improvement in both liver enzymes along with favorable effects on lipid and glycemic indices in patients with non-alcoholic fatty liver disease in Phase II clinical trials.

Evidences II is a Phase 3 biopsy-driven trial of Saroglitazar 4 mg versus Placebo in patients with Non-Alcoholic SteatoHepatitis. The primary endpoint will be evaluated by histological improvement of NASH using liver biopsy at the end of 52 weeks.

Evidences III is the prospective, multicenter, randomised, double-blind study of Saroglitazar 4 mg versus Placebo in patients with Non-Alcoholic Fatty Liver Disease (NAFLD). This trial will measure the change in liver fat content as measured by non-invasive magnetic resonance imaging (MRI) at week 24.

Evidences V will evaluate the NASH patients over a period of 18 months, measure the change in the liver fat content by magnetic resonance imaging-derived proton density-fat fraction (MRIPDFF) at Week 24 and evaluate the liver biopsy driven endpoints of Saroglitazar 4 mg from baseline to Week 76.

On Thursday, the stock of Cadila Healthcare opened at Rs. 241.35 per share. During the morning trading session, it slipped by 1.1 per cent to Rs. 238 from its previous close of Rs. 240.60 per share.