Anthera Pharma (ANTH) Announces CHABLIS-SC1 Trial Missed Primary Endpoint in Active SLE
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Serum biological markers including B-cells, immunoglobulins, and complement demonstrated statistically significant treatment effects consistent with expectations and previous blisibimod clinical studies in lupus and IgA nephropathy. Adverse events between the blisibimod and placebo treatment arms were well balanced and blisibimod was generally well tolerated.
“We are disappointed that the results did not demonstrate a meaningful improvement in patients’ disease activity as assessed by SRI endpoints,” said William Shanahan, M.D., Anthera’s Chief Medical Officer. “We would like to thank the patients, caregivers, investigators and key opinion leaders who made the CHABLIS-SC1 clinical study possible. It has yielded significant amounts of data which we look forward to sharing with the scientific community in the future which we believe will help to further inform the development of treatments for severe lupus.”
The Company will continue to analyze the data in the coming weeks from the CHABLIS-SC1 trial in consultation with key lupus disease thought leaders to expeditiously determine the future of the blisibimod lupus program including the on-going CHABLIS 7.5 clinical study. As the pharmacological effects on immunological markers, such as B-cells and immunoglobulins, were as expected, the company is continuing the development of blisibimod for the treatment of IgA Nephropathy (IgAN) pending 48 week results from the ongoing phase 2 BRIGHT study. IgAN has a very different pathogenesis than systemic lupus, and the pharmacological activity of blisibimod might prove effective in its treatment. The Company expects to report 48-week data from the BRIGHT-SC IgAN study and topline data from the Sollpura™ SOLUTION phase 3 study later this year.
Anthera will host a conference call to further discuss the data from the CHABLIS-SC1 clinical study.
Conference Call Access:
Date: November 10, 2016
Time: 8:30 am Eastern Time
Conference ID: 18122260
Toll-Free Dial-In Number: (855) 226-3021
International Dial-In Number: (315) 625-6892
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