Last Updated : Thursday, July 18, 2019 18:50:29

Zydus Cadila completes 3-phased clinical trial enrollment for drug, to cure liver disorder

AHMEDABAD | MUMBAI | RAJKOT – In a press release submitted to the Indian Stock Exchanges, Ahmedabad headquartered Zydus Cadila Group (Cadila Healthcare Ltd) said of having completed enrollment for three phase clinical trials of drug used to treat the a progressive disease of the liver – NASH.

The press release submitted to the Indian Bourses said that, Zydus Cadila, an innovation-driven, global pharmaceutical company, announced that it has completed enrollment in EVIDENCES 11,EVIDENCES 111andEVIDENCES V Phase3 clinical trials of SaroglitazarMg for treating Non-Alcoholic SteatoHepatitis(NASH).

Patients with NASH have been enrolled in these trials across clinical sites in India and Mexico.

Speaking on the development Pankaj R. Patel, Chairman, Zydus group said,

“We are excited about the progress that SaroglitazarMg has been making in the NASH trials. It is currently being evaluated in over 23 different controlled clinical trials, involving over 3,800 patients. NASH is an area of unmet healthcare need and we are committed to develop this therapy for millions of patients suffering from this deadly disease.” 

EVIDENCES II is a Phase3 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, randomized, double-blind study of Saroglitazar4mg versus Placeboin 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.

Several other secondary endpoints including Liver stiffness as measured by transient elastography/FibroScan@ and Serum alanine aminotransferase (ALT) level will also be evaluated.

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 (MRI-PDFF) at Week 24 and evaluate the liver biopsy driven end points of Saroglitazar 4 mg from baseline to Week 76.

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.

SaroglitazarMg has demonstrated beneficial effects in NASH animal models.

Saroglitazar Mg inflammation and favorably 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.

NASH is a progressive disease of the liver and a significant unmet medical need. Starting with fat accumulation in liver, this condition can progress to cirrhosis and liver failure.

NASH ranks as one of the major causes of cirrhosis, behind hepatitis C and alcoholic liver disease.

Liver transplantation is the only option for managing advanced cirrhosis with liver failure.

There are currently no treatments available for the treatment of NASH.

Zydus Cadila is an innovative, global pharmaceutical company that discovers, develops, manufactures and markets a broad range of healthcare therapies, including small molecule drugs, biologic therapeutics and vaccines.

The group employs over 23,000 people worldwide, including 1400 scientists engaged in R & D, and is dedicated to creating healthier communities globally.


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