Anthera Pharmaceuticals Slides on Missed Late Stage Results

Health and Healthcare

Published: November 10, 2016 11:55 am

Last Updated: January 12, 2020 5:56 pm

Shares of Anthera Pharmaceuticals Inc. (NASDAQ: ANTH) lost roughly one-third of their value on Thursday after the company gave an update on its late-stage Lupus clinical trial. The company announced that the CHABLIS-SC1 clinical trial with blisibimod for the treatment of systemic lupus erythematosus (SLE) failed to meet its primary endpoint.

Although 47% of patients in the blisibimod arm versus 42% of patients in the placebo arm achieved this endpoint, the difference was not statistically significant.

The SRI is a composite index comprised of SELENA-SLEDAI, BILAG and Physician Global Assessment criteria. A SRI-6 response requires a decrease of at least six points in SELENA-SLEDAI. The magnitude of blisibimod treatment effects for other SLE Response (SRI-4, and SRI-8) also did not achieve statistical significance.

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.

William Shanahan, M.D., Anthera’s chief medical officer, commented:

We are disappointed that the results did not demonstrate a meaningful improvement in patients’ disease activity as assessed by SRI endpoints. 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.

Excluding Thursday’s move, Anthera has underperformed the market, with the stock down 40% year to date.

Shares of Anthera were last seen down 34% at $1.81, with a consensus analyst price target of $9.80 and a 52-week trading range of $1.83 to $6.08.

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