By: Jay Silverman
With late-stage clinical trials completing for blisibimod (“b-modâ€) and Sollpura, I expect that 2016 will be a monumental year for this company—my Top Pick for growth in 2016—suggests Jay Silverman, editor of The Medical Technology Stock Letter.
Anthera Pharmaceuticals (ANTH) is nearing the readout of three clinical trials, possibly one in each quarter beginning in Q2:16. For blisibimod (“b-modâ€), the first trial will be look at the Phase II in IgA nephropathy (“IgANâ€).
The primary endpoint is a reduction in proteinurea and that leads to kidney failure in many IgAN patients.
Since b-mod’s mechanism of action and clinical data resulted in a significant reduction in proteinurea in the PEARL studies (2012), and global regulators agreed to this single endpoint in registration trials, we expect the data will be positive.
Afterwards, the Company is likely to sign a new partnership in Japan/Asia, where the incidence of IgAN (~300,000) is three times that of the US (100,000).
In my view, interest from new partners is high and the de-risking of the program with the upcoming data should lead to a sizable partnership.
A Phase III study with b-mod to treat lupus—CHABLIS-SC1—is due to be completed by the end of Q3:16.
A positive interim look in January put b-mod back into the spotlight, and since then, enrollment accelerated and the second lupus registration trial CHABLIS-7.5 is underway.