Anthera Achieves Half of Target Enrollment for Trial of Sollpura as Treatment for CF-related Digestive Disorder
Anthera Pharmaceuticals has enrolled half the patients it is seeking for a Phase 3 clinical trial of Sollpura (lipromatase) as treatment for a cystic fibrosis-related digestive disorder known as exocrine pancreatic insufficiency, or EPI.
The company expects to release the key results of the RESULT trial in late 2017 or early 2018.
“We are very pleased that more than 50% of the anticipated patients needed to complete enrollment have entered screening for the RESULT trial,” Dr. William Shanahan, Anthera’s chief medical officer, said in a press release. “The acceleration of recruitment in recent weeks has been encouraging and validating for the need for an alternative to today’s current enzyme therapies” for treating the disorder.
Many pancreatic enzyme replacement therapies, or PERTs, are derived from pigs.
Sollpura consists of non-pig-derived lipase, protease and amylase enzymes. It helps people digest food better, which leads to them having better nutrition. The therapy’s synthetic origin reduces the risk of a user developing a pig-related disease or conditions such as gout and kidney impairment.
RESULT (NCT03051490) will compare Sollpura’s effectiveness with that of approved pig-derived PERT treatment, such as Pancreaze, in CF patients with EPI.
Anthera is conducting the study at 37 medical facilities in the United States, Europe, and Israel. It is expected to include about 150 people who are using pig-derived PERTs to keep their EPI stable.
Researchers will look at Sollpura and Pancreaze’s ability to help patients do a better job of absorbing fat and nitrogen after four weeks.
The team will follow patients who were randomly assigned to Sollpura for 20 weeks after the treatment, checking their overall health and the therapy’s long-term safety.
“The rapid pace of screening in the RESULT study is a testament to the need for a new therapeutic option for cystic fibrosis patients and caregivers,” said Dr. Michael W. Konstan, deputy dean of the Case Western Reserve University School of Medicine in Cleveland.
“As we move forward with screening and enrollment, we remain excited about this alternative treatment for EPI patients who are unable to maintain appropriate nutritional health, and especially for those who seek soluble or non-porcine [non-pig] therapeutic options,” Konstan added.
Because Sollpura’s formulation is more compact than pig-derived PERTs, it may also reduce the size and number of pills that CF patients need to take each day.
Sollpura has also developed an oral-solution powder that it is evaluating in the SIMPLICITY clinical trial (NCT02734810).
