• The company announced positive results from its Phase 3 CONFIRM trial of terlipressin in Hepatorenal Syndrome Type 1.
• The study verified HRS-1 reversal along with other 3 components-renal function enhancement, escaping dialysis, and short-term survival.

UK based Mallinckrodt plc has reportedly announced positive results for its Phase 3 CONFIRM clinical study assessing the efficiency and safety of terlipressin in the HRS-1 patients. The study is said to have met the chief endpoint of authenticated HRS-1 reversal which includes 3 other components- renal function enhancement, escaping dialysis, and short-term survival.

For the uninitiated, CONFIRM is one of the largest prospective studies conducted in the patients suffering from HRS-1. Additionally, HRS-1 is a severe, erratic and acute disease categorized by complications of liver disease leading to kidney failure. It has a very poor prediction, with an average survival time of less than 2 weeks and greater than 80% mortality within three months.

It has been claimed that Mallinckrodt plans to file a new drug application to the U.S. Food and Drug Administration in the initial months of 2020.

Speaking on the matter, Steven Romano, Executive Vice President and Chief Scientific Officer at Mallinckrodt cited that the company is devoted to enhancing the therapies that treat underserved patients with critical and devastating conditions. He further added that Mallinckrodt is encouraged to have received the positive results of the CONFIRM trial in HRS-1. Additionally, the CONFIRM trial is expected to support the supervisory submissions of terlipressin as a treatment for the syndrome in the United States and Canada.

Meanwhile, Arun Sanyal, M.D., Z. Reno Vlahcevic, Professor of Medicine, Physiology and Molecular Pathology, Virginia Commonwealth University, stated that the preliminary results of the Phase 3 CONFIRM study demonstrated terlipressin reversing the course of HRS-1 by improving renal function, escaping dialysis and providing a short time survival.  

For the records, established in 1840, Mallinckrodt is involved in developing, manufacturing, marketing and delivering specialty pharmaceutical products & therapies globally.

Source credit: http://www.mallinckrodt.com/about/news-and-media/news-detail/?id=26066