Anthera Pharmaceuticals Inc (NASDAQ:ANTH) are having a rough day after the drug maker announced that the CHABLIS-SC1 clinical trial with blisibimod for the treatment of systemic lupus erythematosus (SLE) failed to meet its primary endpoint based upon the SLE Responder Index-6 (SRI-6) at 52 weeks. 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.
In the wake of the announcement, Anthera shares are falling nearly 23% in pre-market trading Tuesday.
“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. (Original Source)
On the ratings front, Jefferies analyst Matthew Andrews reiterated a Buy rating on ANTH, with a price target of $5.00, in a report issued on November 4. The current price target implies an upside of 80% from current levels. According to TipRanks.com, Andrews has a yearly average loss of 5.9%, a 33% success rate, and is ranked #3362 out of 4205 analysts.
Anthera Pharmaceuticals, Inc. is a biopharmaceutical company, which is focused on developing and commercializing products to treat treat serious and life-threatening diseases, including lupus, lupus with glomerulonephritis, IgA nephropathy, and exocrine pancreatic insufficiency due to cystic fibrosis. It develops phase 3 product candidates, which includes blisibimod and liprotamase. Anthera Pharmaceuticals was founded by Paul F. Truex on September 9, 2004 and is headquartered in Hayward, CA.