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Shire’s swelling disorder drug meets primary and secondary endpoints in phase 3 study

PBR Staff Writer Published 19 May 2017

Shire’s swelling disorder treatment, lanadelumab, has met its primary endpoint and all secondary endpoints in a phase 3 study.

The company has reported positive topline phase 3 results for the HELP study, which assessed the efficacy and safety of subcutaneously administered lanadeluma against placebo over 26 weeks in patients 12 years of age or older with Hereditary Angioedema (HAE).

Lanadelumab is an investigational treatment being assessed to prevent angioedema attacks in patients with HAE, a genetic disease characterized by recurrent swelling of extremities, gastrointestinal tract, and upper airways.

It is an investigational fully human monoclonal antibody, which specifically binds and inhibits plasma kallikrein.

According to the company, the global, multi-center, randomized and double-blind placebo-controlled parallel group trial achieved its primary endpoint and all secondary endpoints with statistically significant and clinically meaningful results for all three lanadelumab treatment arms compared to placebo.

For evaluation of lanadelumab, Shire intends to file a biologics license application (BLA) with the US Food and Drug Administration (FDA) by the end of this year or early 2018.

Lanadelumab has already secured orphan drug status and breakthrough therapy status from the FDA, as well as orphan drug designation from the European Medicines Agency (EMA).

The HELP trial included 125 patients with 12 years of age or older with type I/II HAE. They were randomized into four arms to secure repeated subcutaneous administrations of lanadelumab 300 mg every two weeks, 300 mg every four weeks and 150 mg every four weeks or placebo in a 2:1 ratio.

The study’s primary efficacy endpoint was the number of investigator-confirmed angioedema attacks noticed in each lanadelumab treatment arm against placebo arm during the 26 week treatment period.

Shire CEO Dr Flemming Ornskov said: “We have nearly a decade of experience and a strong portfolio and pipeline in HAE and believe these data demonstrate high potential for transforming the way patients living with this condition are treated.”


Image: Shire location in Lexington Massachusetts. Photo: courtesy of John Phelan.