Zydus Lifesciences Limited on Friday announced the commencement of Phase-IV Real World Data registry trial Evidences-XI for Saroglitazar Magnesium (Mg) in Non-Alcoholic Fatty Liver Disease (NAFLD) patients with comorbidities.

The Phase-IV Evidences-XI trial will enrol about 1,500 male and female NAFLD patients with comorbidities such as obesity, type 2 diabetes mellitus, dyslipidemia or metabolic syndrome- 200 patients each. The study duration is approximately 56 weeks.

The primary endpoint is to measure the change in liver stiffness measurement performed by transient elastography from Baseline to Week 52, the company said in a statement.

Saroglitazar Mg has been studied in two well-controlled Phase 3 clinical trials in patients with NAFLD and Non-Alcoholic Steatohepatitis (NASH) in India.

The first Phase III trial was conducted in biopsy proved NASH patients, where Saroglitazar Mg demonstrated a significant difference of 28 per cent versus placebo in the primary endpoint NAFLD Activity Score with no worsening of fibrosis in greater proportion of patients.

In the second Phase III study, patients had a beneficial effect on primary end-point of change in liver fat content as measured by non-invasive magnetic resonance imaging and secondary endpoints, including liver stiffness as measured by transient elastography/FibroScan in patients with NAFLD at week 24.

Rohit Loomba, MD, Professor of Medicine, Division Chief of Gastroenterology at the University of California, San Diego School of Medicine and Director of Hepatology at UC San Diego Health will lead the Steering Committee of the Phase-IV Evidences Real World Data Study.

He termed this Phase 4 Evidences study as a landmark establishing one of the largest prospective registries  of patients with NASH in the world. “It will help generate novel Real World Data (RWD) in NAFLD/NASH patients, especially lacking in Asian population. Real World Data is crucial to formulate clinical guidelines, to further support its use in clinical practice and this will add to our existing knowledge of Saroglitazar Mg and its role in the management of NAFLD/NASH,” he said.

Pankaj R. Patel, Chairman, Zydus Lifesciences Ltd. said, “NAFLD and NASH are serious life-threatening conditions and we have now studied Saroglitazar Mg in over ten different trials which have been completed and the ongoing EVIDENCES I to X series of clinical trials in patients with NAFLD and NASH across clinical sites in India, Mexico, USA and Europe.”

“We hope that this will be a big leap forward in managing and treating the unmet healthcare needs of NAFLD and NASH,” he added.

In the USA, the EVIDENCES-X Phase 2b study of Saroglitazar Mg is currently ongoing in 240 patients with NASH with a 72-week biopsy driven endpoint.

Saroglitazar Mg has been studied in patients with Primary Biliary Cholangitis (PBC), a rare liver disease with two separate EPICS-I and EPICS-II series of trials conducted in USA and Mexico.

A third Phase 2b/3 adaptive trial is currently ongoing in patients with PBC, with sites in USA and Europe.

The USFDA has granted Fast Track status and Orphan Drug Designation for Saroglitazar Mg in PBC. Saroglitazar Mg has also received Orphan Drug Designation in Europe for the treatment of PBC. Once approved, the Orphan drug designation will lead to 10 years of market exclusivity in Europe.

Zydus Lifesciences shares traded nearly flat at ₹510.65 with 0.47 per cent gains at the afternoon trade on BSE Friday.

Related Topics
comment COMMENT NOW