- Fecal Incontinence
Anthera's cystic fibrosis drug fails late-stage study, shares tank
Last Updated: 2016-12-28
By Reuters Staff
(Reuters) - Anthera Pharmaceuticals Inc said on Tuesday that its drug to treat cystic fibrosis patients with exocrine pancreatic insufficiency (EPI) failed a late-stage study, sending the company's shares tumbling nearly 70 percent in after-hours trading.
The latest setback for Anthera comes just over a month after the company said an experimental drug to treat lupus had also failed in a late-stage study.
Anthera's drug Sollpura was being tested for its ability to help patients absorb fat in a non-inferiority trial, where a new treatment has to show it is not clinically worse than an active treatment with regards to specified targets. Sollpura failed on this count when its performance was compared with Janssen Pharmaceuticals' pancreaze, Anthera said.
However, Anthera said Sollpura's ability to absorb protein was not clinically worse and that, based on this finding, it would start a new study in the first quarter of 2017.
"In the SOLUTION study, Sollpura nearly met the non-inferiority margin with respect to fat absorption, and met the statistical criterion for nitrogen absorption. The study data suggest that the deficiency in fat absorption may be addressed by small changes in study design, including more liberal dose adjustment," Dr. Michael Konstan of Case Western Reserve University School of Medicine in Cleveland, Ohio, said in a company press release announcing the results. (http://bit.ly/2iEhUtX)
"A need for alternative treatments remains for EPI patients who are unable to maintain appropriate nutritional health, especially those who seek soluble or non-porcine therapeutic options," Dr. Konstan added.
Anthera's shares were down about 67 percent at 69 cents in trading after the bell on Tuesday. Up to the day's close, they had lost 57 percent this year.