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Ablynx’s vobarilizumab fails to meet primary endpoint in phase II lupus study

PBR Staff Writer Published 27 March 2018

Ablynx’s lupus erythematosus treatment vobarilizumab has failed to meet primary endpoint in the phase II dose-ranging study.

Vobarilizumab is the firm’s anti-IL-6R Nanobody, which did not achieve the primary endpoint of dose response based on the modified BILAG-based combined lupus assessment (mBICLA) at week 24.

Vobarilizuma, which targets the interleukin 6 pathway through IL-6 receptor, is a pro-inflammatory cytokine that has a role in T-cell activation production of acute phase proteins in response to inflammation, induction of immunoglobulin production, and stimulation of osteoclast differentiation and activation.

SLE is a complex, multi-organ and autoimmune disorder recognized by the production of pathogenic autoantibodies and tissue deposition of immune complexes.

The company recruited 312 patients with moderate to severe and active seropositive systemic lupus erythematosus (SLE) across five treatment arms in phase II Steady trial.

The multi-centre, randomized, double-blind, placebo-controlled and dose-range finding phase II study was commenced in August 2015, and enrolled patients across the US, Europe, South America and Asia.

Ablynx randomly assigned patients to one of four dose groups of subcutaneously (sc) administered vobarilizumab or placebo.

According to the company, the primary endpoint of the study was the percentage of subjects who achieved a response at week 24 according to the modified BICLA (BILAG-based combined lupus assessment) score.

Ablynx chief medical officer Robert Zeldin said: “We are disappointed that vobarilizumab didn’t show a dose response in the analysis of the study’s primary endpoint, however, vobarilizumab was well tolerated in all tested dose groups, confirming its favourable safety profile.

“We will continue to analyse the full data set and thank the study participants and their families as well as the investigators and staff who contributed to this study.”

In January this year, French drugmaker Sanofi agreed to acquire Ablynx for about €3.9bn. Sanofi has offered €45 for each of the shares of Ablynx in an all-cash deal.

Image: Vobarilizumab is Ablynx's anti-IL-6R Nanobody. Photo: courtesy of Ablynx.