UCB and Biogen’s lupus drug dapirolizumab pegol failed to clear a phase 2b study, missing its primary endpoint in dose responses compared to placebo.
In addition, Biogen disclosed that it discontinued development of its vixotrigine treatment for sciatic nerve pain in the lower back and legs, after a separately poor phase 2b showing.
Dapirolizumab pegol, an anti-CD40L antibody, joins other mid- and late-stage lupus trial failures seen this year, including treatments from AstraZeneca and Ablynx, the latter of which was set to be acquired by Sanofi as part of a multibillion dollar takeover.
UCB and Biogen’s study enrolled 182 patients who had persistent systemic lupus erythematosus despite treatment with standard-of-care corticosteroids, anti-malarials and nonbiological immunosuppressants.
The responses seen with dapirolizumab pegol, with its pegylated antigen-binding regions, were not statistically significant, posting a p-value of 0.06 after 24 weeks of treatment. However, the two companies said the study demonstrated “consistent and potentially meaningful improvements for the majority of clinical endpoints” and an acceptable safety profile, and that they would continue to evaluate the data.
Back in March, Ablynx’s anti-IL-6R, single-domain antibody vobarilizumab was unable to demonstrate a significant dose response over the same timeframe, in a phase 2 trial of 312 patients.
Sanofi had inked a $4.8 billion takeover of Ablynx not two months before, in a move to outbid Novo Nordisk for the Belgian company. The deal also included the rare blood disorder drug caplacizumab—approved in Europe last month as Cablivi—plus a phase 2 respiratory syncytial virus candidate, ALX-0171.
Meanwhile, the future of AstraZeneca’s anifrolumab lupus treatment saw some doubt in August after it missed the first of two phase 3 trials, despite promising mid-stage results. Its second trial is due to report data before the end of the year.
Anifrolumab is also being studied in kidney damage caused by lupus, as well as in a subcutaneous formulation—precariously holding up a sizable portion of AZ’s autoimmune drug pipeline.
Separately, Biogen’s vixotrigine analgesic—at various times referred to as BIIB074 or raxatrigine—did not meet its primary or secondary efficacy endpoints in painful lumbosacral radiculopathy, also known as sciatica.
Biogen has decided to drop the drug in the indication, although vixotrigine is being studied in small fiber neuropathy and trigeminal neuralgia, which involves severe pain on one side of the face.
Biogen obtained vixotrigine, also known as CNV1014802, in a $675M buyout of Convergence Pharmaceuticals in 2015. The phase 2b extension study results, evaluating 302 participants, were received by the company in September and disclosed in its third-quarter earnings report (PDF) with little additional detail.
The company also said it will delay the launch of a planned phase 3 study in trigeminal neuralgia, pending the outcome of meetings with the FDA regarding trial design, as well as more detailed reviews of an ongoing small fiber neuropathy trial and the failed sciatica study.