An independent review board has given a green light to Anthera Pharmaceuticals continuing a Phase 3 clinical trial evaluating Sollpura’s (lipromatase’s) ability to treat a cystic fibrosis-related digestive disorder.
It was the second time that the Data Monitoring Committee had decided that interim findings were good enough for the RESULT trial (NCT03051490) to continue. The study is comparing Sollpura’s and the standard treatment Pancreaze’s ability to treat exocrine pancreatic insufficiency. The committee consists of experts appointed by the Cystic Fibrosis Foundation’s Therapeutics Development Network.
The second positive review “of the RESULT study represents one of the last clinical [trial] milestones ahead of topline data [the study results] this quarter,” Craig Thompson, the president and CEO of Anthera, said in a press release. “We look forward to sharing the study outcome shortly and potentially providing patients with a new treatment option for their exocrine pancreatic insufficiency therapy.”
A hallmark of CF is overproduction of thick mucus in several places in the body. One manifestation of this is the pancreas being unable to generate enough of the enzymes the gut needs for digestion. To overcome this, CF patients can receive pancreatic enzyme replacement therapies, which are commonly derived from pigs.
Sollpura consists of non-pig-derived lipase, protease, and amylase enzymes. Its synthetic origin reduces the risk of patients developing a pig-related disease or conditions such as gout and kidney impairment.
Because Sollpura’s formulation is more compact than pig-derived enzyme replacement therapies, it can also reduce the size and number of pills that CF patients must take each day to achieve similar results.
In a previous Phase 3 trial, the SOLUTION study (NCT02279498), researchers demonstrated Sollpura was as effective as pig-derived Pancreaze. The RESULT trial is further evaluating Sollpura capsules in comparison with Pancreaze as a treatment for exocrine pancreatic insufficiency. This time researchers are adjusting dose levels and frequency to meet individual participants’ needs.
Anthera completed patient recruitment in the RESULT trial in November 2017, reaching 150 participants at 37 medical facilities in the United States, Europe, and Israel.
The company expects to present the findings by the end of the first quarter of 2018.
Anthera has also developed a powder formulation of Sollpura for oral administration that is being evaluated in the Phase 3 SIMPLICITY clinical trial (NCT02734810).