Mallinckrodt (MNK) Presents Clinical Data for TERLIVAZ

Mallinckrodt plc (NYSE American: MNK), a global specialty pharmaceutical company, today announced the presentation of results from two clinical studies in adults with hepatorenal syndrome (HRS) with rapid reduction in kidney function¹ treated with TERLIVAZ^® (terlipressin) for injection at the American Transplant Congress (ATC) 2023, taking place in San Diego, Calif. from June 3-7, 2023. The results of the two studies – a pooled analysis of two Phase III terlipressin trials (REVERSE, CONFIRM) and a retrospective analysis of the Phase III CONFIRM trial – will be presented in oral lecture sessions on June 5, 2023, at 4:30 p.m. and 4:40 p.m. PT, respectively.^2,3

TERLIVAZ (terlipressin) for injection is a synthetic vasopressin analogue indicated to improve kidney function in adults with HRS with rapid reduction in kidney function.¹ Patients with a serum creatinine >5 mg/dL are unlikely to experience benefit.¹

Please see Important Safety Information, including Boxed Warning, below.

TERLIVAZ is the first and only FDA-approved product indicated for the treatment of adults with HRS involving rapid reduction in kidney function,¹ an acute and life-threatening condition requiring hospitalization.⁴ Terlipressin is recommended by the American Association for the Study of Liver Diseases (AASLD) guidance⁵ and the American College of Gastroenterology (ACG) guidelines.⁶

The findings from the pooled analysis of the Phase III REVERSE and CONFIRM studies, presented by Adnan Said, University of Wisconsin Hospital and Clinics, Madison, Wis., provide insight into clinical outcomes following terlipressin therapy compared with placebo in patients with HRS type 1 (HRS-1) and systemic inflammatory response syndrome (SIRS).² Furthermore, the results of the retrospective analysis of the Phase III CONFIRM trial, presented by Fredric Gordon, Tufts Medical Center, Boston, Mass., offer perspective into terlipressin's therapeutic potential to reduce renal replacement therapy (RRT) requirements post-liver transplant in HRS-1 patients with acute-on-chronic liver failure (ACLF) grade 0-2 and serum creatinine (SCr) levels <5 mg/dL.³

Renal failure requiring hemodialysis post-liver transplant is a major risk factor for death in liver transplant recipients.⁷ Patients who require post-transplant dialysis also have significantly worse graft survival compared with those without post-transplant dialysis.⁸

"We are excited to share findings from our latest clinical research that not only support the use of terlipressin to improve kidney function for appropriate patients with HRS involving rapid reduction in kidney function,^1,3 but also aim to generate increased awareness and understanding among healthcare professionals of the treatment considerations and goals for HRS patients with burdensome comorbidities, like systemic inflammatory response syndrome,²" said Khurram Jamil, Vice President & Head, Hepatology, Clinical Development & Critical Care at Mallinckrodt. "This research reflects Mallinckrodt's ongoing commitment to serve the needs of both critically ill patients and the physicians responsible for their care by expanding our collective understanding of the progression and clinical management of HRS."

Liver transplantation is the only definitive treatment for patients with HRS with rapid reduction in kidney function,¹ yet the majority of HRS patients still face access challenges.⁹ In light of these ongoing challenges, improving transplant outcomes – and conducting research that provides insight into the clinical management of these critically ill patients – is essential to addressing the scarcity of available liver transplants and other prominent unmet needs.⁷

These studies were sponsored by Mallinckrodt Pharmaceuticals:

Presenting Monday, June 5, 2023; 4:30 p.m. PT

• Oral Presentation 321: Terlipressin Improves Clinical Outcomes in Patients with Hepatorenal Syndrome Type 1 and Systemic Inflammatory Response Syndrome: A Pooled Analysis of the Phase III REVERSE and CONFIRM Studies²
  • Presenter: Adnan Said, University of Wisconsin Hospital and Clinics, Madison, Wis.

Presenting Monday, June 5, 2023; 4:40 p.m. PT

• Oral Presentation 322: Liver transplant rates and clinical outcomes in patients with hepatorenal syndrome type 1 and ACLF grade 0−2 and serum creatinine (SCr) <5 mg/dL at baseline³
  • Presenter: Fredric Gordon, Tufts Medical Center, Boston, Mass.

Find more information on the American Transplant Congress 2023 Meeting website.

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