Zydus Cadila starts phase 2 clinical trial in NAFLD

Zydus Cadila announced on Wednesday that it has initiated a Phase 2 clinical trial for gauging the effect of Saroglitazar Mg in the treatment of Non-Alcoholic Fatty Liver Disease (NAFLD) in women suffering with polycystic ovary syndrome (PCOS). The EVIDENCES VII trial is currently recruiting patients across several clinical sites in USA and Mexico.

Research suggests that in women with PCOS, the risk for NAFLD has increased. PCOS affects fertility and also significantly increases metabolic complications. PCOS is caused due to factors like obesity or insulin resistance, affecting liver function and leading to NAFLD. Till now, the USFDA has not approved any treatments for NAFLD or Non-Alcoholic Steatohepatitis (NASH).

There is a high prevalence of PCOS in the general population affecting 1 in 10 women of childbearing age, causing infrequent or prolonged menstrual periods or excess male hormone (androgen) levels.

The trial will evaluate the change in hepatic fat content from baseline following 24 weeks of treatment as measured by MRI-PDFF in patients treated with Saroglitazar Magnesium. The secondary endpoints of the trial also include measurements of liver enzymes, insulin resistance, liver fibrosis, liver stiffness, BMI, waist circumference, MRI derived measures of total liver fat index, MRI-derived measures of total liver volume, lipid and lipoprotein levels, SHBG level, ovarian function, free androgen index and pharmacokinetic parameters.

Also, it has received final approval from the USFDA to market Ranolazine ExtendedRelease Tablets, 500 mg and 1000 mg. The said tablet is used with other medicines that are used for heart problems and blood pressure control. The group has 271 approvals and has so far filed over 360 ANDAs since the commencement of the filing process.

On Wednesday, the stock of Cadila Healthcare opened flat at Rs 219.45. In the morning trading session, it was down by 1.4 per cent at Rs 216.20.