The RESULT Phase 3 clinical study of Sollpura from Anthera Pharmaceuticals Inc. (NASDAQ:ANTH) did not meet the non-inferiority margin of the CFA primary endpoint. The study put together 140 patients in North America, Eastern and Western Europe and Israel and had the approval from the Cystic Fibrosis Foundation Therapeutics Development Network (“CFFTDN”) Protocol Review Committee.
Every patient randomized to Sollpura obtained a starting done. Apparently, the dose was 25% higher than what was administered during the pre-study of porcine pancreatic enzyme replacement therapy (“PERT”). The previous Phase 3 SOLUTION study included more aggressive dose optimization. However, some of those randomized to Sollpura improved their CFA from baseline.
It has been a rough ride for the drug
Anthera has had a share of setbacks over the years and Sollpura has not been lucky. The drug was out-licensed by Lilly back in 2014 and it seems like all was well at the beginning. It testing its effectiveness in helping CF patients absorb fat but it narrowly missed out on meeting the expectations.
A few years back, the company’s experimental med, blisibimod, which was testing for systemic lupus erythematosus failed to meet its primary endpoint. All these events have caused such a huge fall the shares of Anthera, which plunged more than 80% premarket.
Anthera Pharmaceuticals plans to evaluate the full data outputs
Given the competition in the market today, any company receiving negative finding regarding any study feels disappointed. Craig Thompson, President & CEO of Anthera Pharmaceuticals says, “We are greatly disappointed by the findings of the RESULT study”. However, he goes ahead to that all the study investigators, patients, and families who played a role in the clinical development of Sollpura.
That said, the company has taken up the commitment suspending further clinical development of Sollpura. It will not also indulge itself in the 20-Week Extension Period of RESULT as well as the SIMPLICITY study in patients ages 28 days to <7 years. Instead, Anthera Pharmaceuticals will be taking time off to evaluate the full data outputs. It will also be evaluating possible strategic alternatives, which will be maximizing the shareholder value.