Anthera Pharmaceuticals (ANTH): Protecting Investment and Riding Free Shares

Anthera Pharmaceuticals, Inc. (ANTH) stock gained today 87.24% on 23.9M shares in volume. We profiled ANTH as a potential bounce candidate right after the company’s report of the mixed results for its Phase 2b PEARL-SC clinical study in patients with systemic lupus erythematosus.

Market was definitely overreacted on this news; Anthera has confirmation from the European Medicines Agency (EMA) for the acceptability of the Company’s proposed Phase 3 design for the treatment of severe systemic lupus erythematosus patients as a basis for a marketing authorization application (MAA). The EMA feedback confirms that Anthera’s development program, including the heightened SRI-5 endpoint, is acceptable and that positive results from Phase 3 clinical studies in a severe lupus population would support approval of the product.

Today Anthera Pharmaceuticals came out with the positive clinical data from the Phase 2b PEARL-SC study in patients with systemic lupus erythematosus:

Final data from the PEARL-SC clinical study with 200mg weekly blisibimod suggest sustained and greater treatment effects versus placebo utilizing 6, 7, and 8-point improvements in the SELENA-SLEDAI disease-scoring index (Table 1). In the predefined population of patients with severe disease who were also taking corticosteroids, the SRI-8 treatment benefit in the 200mg weekly blisibimod cohort was seen as early as week eight and achieved statistical significance starting at week 16 (35.4% blisibimod response versus 17.0% placebo response, p=0.04) through the 24 week endpoint (41.7% blisibimod response versus 10.4% placebo response, p<0.001).
Additional data regarding time to first severe flare, total flares, proteinuria, and patients achieving a reduction of steroid dose below 7.5mg per day were also positive. Amongst subjects treated with 200mg of blisibimod weekly, the mean time to first severe flare was 1.6-fold longer than subjects treated with placebo (348 days versus 223 days). The reduction in proteinuria at week 24 was significantly greater amongst subjects treated with blisibimod compared to placebo (35.0% versus 5.1%, p=0.045).

Colin Hislop, MD, Anthera’s Senior Vice President and Chief Medical Officer, commented:

These results continue to validate the importance of phase 2 studies to identify the appropriate patient, dose and endpoint in order to optimize our phase 3 study design. Specifically, the PEARL-SC SRI response using larger improvements in SELENA-SLEDAI appear substantially better than the SRI-5 data. In fact, the SRI-8 data, representing an improvement in SELENA-SLEDAI of eight points or greater achieves statistical significance at multiple time points including at 24 weeks. Due to the consistently better effects at higher thresholds, it appears that if a blisibimod patient responds, they respond very well; additional clinical data suggest positive trends in time to severe flare, flare rates, proteinuria, and steroid utilization.

We protected our initial investment in ANTH from the average of $.70/share at the end of today’s trading session and will ride the rest to $2+ a share.

Anthera Pharmaceuticals‚ Inc.
25801 Industrial Blvd, Suite B
Hayward‚ CA 94545
Tel: (510) 856–5600
Fax: (510) 856–5597
http://www.anthera.com/

Anthera Pharmaceuticals is a biopharmaceutical company focused on developing and commercializing products to treat serious diseases associated with inflammation, including cardiovascular and autoimmune diseases.

ANTH, Anthera Pharmaceuticals