- Shares in California biopharma Anthera plunged by almost a third Thursday after news its lupus drug blisibimod failed to meet its primary endpoint in a Phase 3 study.
- Although nearly half of patients had an improvement in disease as measured by the SLE Responder Index-6, over 40% of those on placebo improved as well. Adverse events were similar between the two treatment arms.
- Anthera said it would continue to analyze the trial data to determine the fate of another ongoing trial of blisibimod in lupus and an earlier-stage study in IgA nephropathy.
News of Anthera's trial failure has battered the company's share price and cast uncertainty on the future of blisibimod in lupus. Twelve-month data from Anthera's Phase 2 study of blisibimod in IgA nephropathy isn't expected until December of next year.
Analysts from Jefferies pointed out the placebo response was higher than expected. In the CHABLIS-SC1 study, physicians could taper treatment with steroids beginning in week 8. Anthera CMO William Shanahan, speaking on an analyst call Thursday, suggested that high baseline dose of steroids in both groups may have masked the benefit of the steroid tapering.
The other study for blisibimod in lupus is still recruiting, and Anthera will update investors in about 90 days to confirm the status of the drug.
"We are disappointed that the results did not demonstrate a meaningful improvement in patients' disease activity as assessed by SRI endpoints," Shanahan said. "[The study] has yielded significant amounts of data… which we believe will help to further inform the development of treatments for severe lupus."
Systemic lupus erythematosus (lupus or SLE), an autoimmune disease, causes rashes, fatigue and joint pain and swelling. There is no cure, and treatments for the symptoms include antimalarials, corticosteroids or immunosuppressants. GlaxoSmithKline's drug Benlysta was the first new drug to be approved by the FDA in over 50 years, despite concerns about its marginal efficacy.
Anthera's other clinical stage drug, Sollpura, is in Phase 3 for treatment of exocrine pancreatic insufficiency in patients with cystic fibrosis.