Failed again: Sanofi’s Ablynx reports PhII lupus flop

After losing its high-profile rheumatoid arthritis partnership just two years earlier, Sanofi’s Belgium-based biotech Ablynx could once again put an AbbVie pact on the chopping block after posting a Phase II flop this morning.

Ablynx reported out bad news that vobarilizumab disappointed yet again, failing to meet its primary endpoints in a Phase II lupus study. It’s the same drug that fizzled in RA, which AbbVie punted back in 2016.

The drug was the subject of a global licensing agreement inked with AbbVie back in 2013, which came with an upfront payment of $175 million and milestones up to $665 million. The deal gave AbbVie the option to license vobarilizumab in RA and in lupus. It’s unclear what AbbVie will choose, but the future isn’t looking good for vobarilizumab.

Robert Zeldin

“AbbVie will review the complete data set when available from the Phase II Steady SLE study to determine whether to exercise its option to license vobarilizumab,” Ablynx said in a statement. “Should AbbVie exercise the option, it would trigger a payment to Ablynx. If the option is not exercised, Ablynx’s agreement with AbbVie would terminate.”

Ablynx, which has a nanobody platform tech and several drugs in its pipeline, was snatched up by Sanofi for $4.8 billion in January. That was after shooting down two previous bids from Novo Nordisk. The deal got Sanofi Ablynx’s lead drug caplacizumab, which has shown considerable promise in treating the ultra-rare blood clotting disorder acquired thrombotic thrombocytopenic purpura (aTTP).

Still, the vobarilizumab failure will likely sting. The failed Phase II study enrolled 312 patients with lupus across five treatment arms. Adverse events that led to study drug discontinuation were reported in 12.4% of all vobarilizumab treated patients compared to 6.5% in the placebo group. Two deaths were reported in the vobarilizumab group.

“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 favorable safety profile,” said Ablynx CMO Robert Zeldin in a statement. “We will continue to analyze the full data set and thank the study participants and their families as well as the investigators and staff who contributed to this study.”