Mid-stage trial of Ablynx's vobarilizumab in lupus fails to hit main goal

Ablynx said Monday that a Phase II study of the experimental anti-IL-6R Nanobody vobarilizumab in patients with systemic lupus erythematosus (SLE) failed to meet its primary endpoint of dose response based on the modified BILAG-based combined lupus assessment (mBICLA) at week 24. Chief medical officer Robert Zeldin noted that the company was "disappointed" with the top-line findings, adding "we will continue to analyse the full data set."

In 2013, Ablynx signed a deal with AbbVie for the development and commercialisation of vobarilizumab in SLE and rheumatoid arthritis. However, in 2016, AbbVie decided not to exercise its right to opt-in and license the drug, also known as ALX-0061, in rheumatoid arthritis.

FirstWord reports in this therapy area - KOL Insight SLE: Find out how KOLs expect the market to evolve, which pipeline treatments are most promising, and which clinical trials will shape treatment decisions. Learn more.

The mid-stage STEADY trial randomised 312 patients with moderate-to severe, active seropositive SLE to receive one of four dose regimens of vobarilizumab or placebo. Ablynx noted Monday that AbbVie will review the complete data set when available from the study to determine whether to exercise its option to license vobarilizumab. The drugmaker indicated that if the option is not exercised, the companies' agreement would terminate.

Earlier this year, Novo Nordisk disclosed an offer to acquire Ablynx for a total equity value of around 2.6 billion euros ($3.2 billion), with the proposal including a contingent value right, part of which was linked to AbbVie deciding to exercise its opt-in right to license vobarilizumab following completion of the STEADY trial. However, Ablynx's board declined to engage in discussions with Novo Nordisk, with the company later entering a definitive agreement to be acquired by Sanofi for approximately 3.9 billion euros ($4.8 billion).

For related analysis, see ViewPoints: Needs must for Sanofi as it doubles down on M&A.

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