Anthera Pharmaceuticalshas received news that could help it accelerate patient enrollment in aPhase 3 clinical trial ofSollpura (liprotamase)as a treatment for a digestive disorder known as cystic fibrosis-triggered exocrine pancreatic insufficiency. <\/p>\n
The news is that a key Cystic Fibrosis Foundation committee approved the companys trial design. The sign-off from the foundationsTherapeutics Development NetworkProtocol Review Committee could lead to additional medical facilities taking part in the trial. And more facilities could mean stepped-up patient recruitment. <\/p>\n
Depending on the speed of patient enrollment, results of the study are expected by years end or in early 2018, the company said. <\/p>\n
Exocrine pancreatic insufficiency, a common feature of CF, makes it more difficult for a person to digest food. It stems from the thick mucus associated with cystic fibrosis blocking the discharge of enzymes the pancreas creates to facilitate digestion. <\/p>\n
Sollpura isa pancreatic enzyme replacement therapy, or PERT. It contains the enzymes lipase, protease and amylase in the same concentrations that are found inthe stomach. <\/p>\n
Most PERTs are derived from pigs. Sollupura isnot, which means it overcomes risks associated with obtaining enzymes from the animals. Those risks include viral contamination and limited supply. <\/p>\n
The Phase 3 RESULT clinical trial (NCT03051490) that Anthera has just started will build on results of the Phase 3 SOLUTION trial (NCT02279498). SOLUTION demonstrated that Sollpura was as effectiveat treatingexocrine pancreatic insufficiency asPancreaze (pancrelipase), a pig-derived PERT. <\/p>\n
A key finding of the SOLUTION trial was that both Sollpura and Pancreaze maintained patients height and weight, an indication their bodies were getting enough nutrients. <\/p>\n
TheRESULT trial will further assess Sollpura capsules ability to overcome CF patientsexocrine pancreatic insufficiency, compared with Pancreaze. Researchers will adjust doses individually to try to achieve the best results. <\/p>\n
We are very pleased to leverage the CFF TDN [Cystic Fibrosis Foundation] clinical trial network and are excited by the progress made with the implementation of the RESULT study, William Shanahan, chief medical officer of Anthera Pharmaceuticals, said in a press release. <\/p>\n
Researchers are hoping to enroll 150 adults and children for the RESULT trialin the United States, Europe and Israel. <\/p>\n
For more information about the trial and how to participate, please visit this link. Or you cancontact Monica Gangal by calling 1-510-856-5600 in the United States or email her atmgangal@anthera.com<\/a>. <\/p>\n<\/p>\n <\/p>\n Read more here: <\/p>\n Cystic Fibrosis Foundation Opens Door to Anthera Speeding Up Trial of Digestive Disorder Therapy - Cystic Fibrosis News Today<\/a><\/p>\n","protected":false},"excerpt":{"rendered":" Anthera Pharmaceuticalshas received news that could help it accelerate patient enrollment in aPhase 3 clinical trial ofSollpura (liprotamase)as a treatment for a digestive disorder known as cystic fibrosis-triggered exocrine pancreatic insufficiency. The news is that a key Cystic Fibrosis Foundation committee approved the companys trial design. Continue reading