December 28, 2016
By Mark Terry, BioSpace.com Breaking News Staff
Hayward, Calif. – Anthera Pharmaceuticals announced that its Sollpura to treat cystic fibrosis patients with exocrine pancreatic insufficiency (EPI) failed to meet its primary endpoint in a Phase III study.
The company emphasized that it only narrowly missed the primary endpoint, which was non-inferiority for change in the Coefficient of Fat Absorption (CFA). And that the drug did meet the non-inferiority criterion. It also confirmed that the ratio of the three enzymes in the drug showed an appropriate response in the coefficient of nitrogen absorption (CNA).
Anthera indicated that during its analysis, the patients were unable to increase their doses because of time restrictions and the protocol design. In addition, other patients couldn’t increase their dose to the daily limit for porcine pancreatic enzyme replacement therapies (PERTs). As a result, and because of faith in the analyzed Sollpura activity data, the company will launch an additional trial of the drug that it believes will optimize dosing and dose titration. It’s expected to start in the first quarter of 2017 and will result in “only a modest delay in the filing of the BLA” around the first quarter of 2018.
Anthera took a dive at the news. Shares traded for $1.99 on December 27 and are currently trading for $0.72.
The company faced another setback in November when it announced the CHABLIS-SC1 clinical trial with blisibimod to treat systemic lupus erythematosus (SLE) didn’t meet its primary endpoint.
And shortly afterwards, the company shook up its leadership team. J. Crag Thompson stepped in as chief executive officer, replacing Paul Truex. Truex took over as chairman of the board, replacing Christopher Henney, who is remaining on the company’s board of directors. The company at the time indicated that Thompson’s promotion was in preparation for the commercial launch of Sollpura and the continued development of blisibimod for IgA nephropathy.
Of Sollpura, John Carroll, writing for Endpoints News, said, “This is a drug with multiple failures to contend with. Eli Lilly tried the pancreatic enzyme replacement therapy liprotomase in a Phase III and failed in 2011. Anthera acquired the drug in 2014. It is designed to treat low digestive enzyme levels, or Exocrine Pancreatic Insufficiency, caused by CF.”
Investors weren’t terribly happy in November when blisibimod failed its clinical trial, and the recent plunge indicated they’re even less happy about the results of the Sollpura trial. And in quoting from an optimistic investors’ note by Jefferies’ Matthew Andrews written several weeks ago, Carroll speculates on whether the backlash will be even worse.
Andrews wrote, “We believe the Phase III study has a high likelihood of success based on its non-inferiority design, a well-controlled patient population enrolled in the study (potential for less variability in efficacy), improved formulation (higher lipase dose), and weight-based dosing (vs. fixed dosing in the prior Lilly-sponsored Phase III study). The study has successfully passed two safety reviews by the data monitoring board.”
It’s possible, of course, that the additional trial will solve the problem, although if it doesn’t, the company is going to have some explaining to do.
“Although we are disappointed to narrowly miss the primary endpoint, we remain encouraged by the overall SOLUTION study results and look forward to releasing final data from its 12-week extension phase in the future, the SIMPLICITY study and the continuation of the open-label EASY study,” said William Shanahan, Anthera’s chief medical officer, in a statement. “We would like to thank the patients, investigators and study staff for their hard work and dedication to our study. We are most grateful for their commitment to our shared hope of developing new treatments for exocrine pancreatic insufficiency, and believe that the shortcomings of Sollpura in SOLUTION can be addressed in the new study that we plan to initiate in 1Q’17.”
