Mallinckrodt plc (NYSE: MNK), a global biopharmaceutical company, today announced it will present results from its pivotal Phase 3 CONFIRM study in a late-breaker session on Monday, Nov. 11 at 3:30 pm ET during The Liver Meeting® 2019, the annual meeting of the American Association for the Study of Liver Diseases (AASLD) in Boston.
| STAINES-UPON-THAMES, United Kingdom, Oct. 21, 2019 /PRNewswire/ -- Mallinckrodt plc (NYSE: MNK), a global biopharmaceutical company, today announced it will present results from its pivotal Phase 3 CONFIRM study in a late-breaker session on Monday, Nov. 11 at 3:30 pm ET during The Liver Meeting® 2019, the annual meeting of the American Association for the Study of Liver Diseases (AASLD) in Boston.
“We are honored to be presenting our CONFIRM abstract at AASLD,” said Steven Romano, M.D., Executive Vice President and Chief Scientific Officer at Mallinckrodt. “We are dedicated to developing potential treatments for patients with severe and critical conditions, including complications of advanced liver disease, such as hepatorenal syndrome type 1.” The CONFIRM clinical trial assessed the efficacy and safety of terlipressin in 300 adults with hepatorenal syndrome type 1 (HRS-1), an acute and life-threatening syndrome involving acute kidney failure in people with cirrhosis.1 CONFIRM is the largest prospective trial ever conducted in this patient population. Mallinckrodt announced in August that the study met its primary endpoint of verified HRS-1 reversal (p=0.012). “Verified HRS-1 reversal” is a term denoting three components: renal function improvement, avoidance of dialysis and short-term survival. The company plans to submit a New Drug Application to the U.S. Food and Drug Administration (FDA) in early 2020. Terlipressin is an investigational product and its safety and effectiveness have not yet been established by the FDA or Health Canada. “HRS-1 is estimated to affect between 30,000 and 40,000 patients in the U.S.2,3 annually. It is a rapidly progressing and devastating condition, and many patients don’t live beyond a few weeks if left untreated,”4,5 said presenting author Florence Wong, MBBS, MD, FRACP, FRCPC, hepatologist at Toronto General Hospital, and professor of Medicine at the University of Toronto. “I am encouraged by the results of the CONFIRM trial of terlipressin, which, if approved, may make a difference in this difficult-to-treat patient population and I look forward to sharing these results for the first time at AASLD.” HRS-1 has a very poor prognosis, with a median survival of less than two weeks and greater than 80 percent mortality within three months if left untreated.4,5 At present, there are no approved drug therapies for HRS-1 in the U.S. or Canada.6 About the Pivotal Phase 3 CONFIRM Study (multi-center, randomized, placebo-controlled, double-blind trial in the U.S. and Canada):7
Find out more information about the CONFIRM trial here on the ClinicalTrials.gov website. About Terlipressin ABOUT MALLINCKRODT Mallinckrodt uses its website as a channel of distribution of important company information, such as press releases, investor presentations and other financial information. It also uses its website to expedite public access to time-critical information regarding the company in advance of or in lieu of distributing a press release or a filing with the U.S. Securities and Exchange Commission (SEC) disclosing the same information. Therefore, investors should look to the Investor Relations page of the website for important and time-critical information. Visitors to the website can also register to receive automatic e-mail and other notifications alerting them when new information is made available on the Investor Relations page of the website. CAUTIONARY STATEMENTS RELATED TO FORWARD-LOOKING STATEMENTS CONTACT For Financial/Dailies Media Inquiries Investor Relations Mallinckrodt, the “M” brand mark and the Mallinckrodt Pharmaceuticals logo are trademarks of a Mallinckrodt company. Other brands are trademarks of a Mallinckrodt company or their respective owners. © 2019 Mallinckrodt. US-1901869 10/19 References 1 National Organization for Rare Disorders. Hepatorenal Syndrome. Available at: https://rarediseases.org/rare-diseases/hepatorenal-syndrome/. Accessed April 9, 2019
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Company Codes: NYSE:MNK |
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