- A licensing agreement between AbbVie Inc. and Ablynx NV looks even more precarious now that the drug at the center of the deal has failed a mid-stage trial evaluating it in lupus patients.
- Topline results released Monday show too few participants taking Ablynx's vobarilizumab achieved a response at Week 24, the STEADY trial's primary endpoint. Investigators tested four treatment regimens in total.
- Vobarilizumab targets the receptor for an immune system-regulating protein called interleukin 6. In 2013, AbbVie handed over $175 million upfront for an option to license the drug for the treatment of inflammatory diseases, including rheumatoid arthritis (RA) and lupus. But following another Phase 2 study that read out in late 2016, the pharma decided not to opt-in on the RA indication, which put added pressure on vobarilizumab to hit in lupus.
There's ample money on the line with vobarilizumab. Per deal terms, Ablynx could receive up to $665 million from AbbVie in development, regulatory and commercial milestones.
Yet the Belgian biotech surely lost out on some of that potential revenue when its partner pulled away from developing vobarilizumab for RA. AbbVie's decision also burdened Ablynx with advancing the drug solo for that indication.
In lupus, Ablynx stands to receive a $25 million milestone payment if AbbVie decides to opt-in. The latest clinical results don't appear to bode well for that outcome, however.
"When available, we will review the complete data package from the Phase 2 STEADY [systemic lupus erythematosus] study to determine whether to exercise our option to license vobarilizumab," a spokesperson for AbbVie said in an emailed statement.
Ablynx has indicated that if AbbVie doesn't opt-in, then it's once again working alone on an indication for the drug. Fortunately for the company, it isn't as reliant on partnerships anymore — Sanofi SA earlier this year beat rival Novo Nordisk AS in a bid to acquire the biotech, ultimately agreeing to drop €3.9 billion ($4.8 billion).
With the deal slated to close in the second quarter, Ablynx will soon have access to considerable amounts of cash to conduct clinical research for vobarilizumab. To that end, investors had a muted reaction to the trial miss, with Ablynx shares down a tiny fraction of a percent in Monday morning trading. The company's stock is up significantly since conducting an initial public offering last year.
Mixed or wanting results in various indications make it unclear exactly what further research will entail, though.
"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," said Robert Zeldin, chief medical officer at Ablynx, in a March 26 statement.
According to Ablynx, 2% of all patients who received vobarilizumab experienced treatment-related serious adverse events versus 6.5% for those on placebo. Also, a smaller percentage of patients in the experimental arms developed serious infections compared to the placebo arm.
More than 12% of all vobarilizumab-treated patients discontinued the study due to treatment-related adverse events, whereas 6.5% discontinued in the placebo group. Two patients in the vobarilizumab group died, but Ablynx offered up no further details on the circumstances.