Anthera Pharmaceuticals recently announced that it received a $3 million award from the Cystic Fibrosis Foundation Therapeutics to support both the manufacturing and clinical development of Sollpura™ (liprotamase), Anthera’s new pancreatic enzyme replacement therapy. Cystic Fibrosis Foundation Therapeutics is an affiliate of the Cystic Fibrosis Foundation, a non-profit organization.
Anthera Pharmaceuticals is a bio-pharmaceutical firm developing and commercializing drugs to address treatment for life-threatening diseases. The company is developing liprotamase, an investigational non-porcine, stable and soluble enzyme therapy appropriated for those with lower levels of digestive enzyme, or Exocrine Pancreatic Insufficiency (EPI) caused by several diseases, including Cystic Fibrosis. EPI is a condition characterized by lower absorption of nutrients and fat because of a reduction in the amount of digestive enzymes the pancreas produces. According to estimates from the Cystic Fibrosis Foundation, approximately 90 percent of individuals who suffer with cystic fibrosis also have pancreatic insufficiency and need to take pancreatic enzymes with every single meal and snacks so they can effectively absorb vital nutrients in the food they eat.
Anthera intends to begin a Phase 3 registration trial entitled SOLUTION to assess liprotamase in the 3rd quarter of this year. If the trial yields positive results, Anthera will complete all of the regulatory and clinical activities needed for a New Drug Application to the United States Food and Drug Administration.
Paul F. Truex who is Anthera’s President and CEO said in a press release: “We are excited about the possibility of offering an alternative pancreatic enzyme therapy to people with CF. Support from Cystic Fibrosis Foundation Therapeutics speaks to the importance of developing liprotamase and the organization’s extensive clinical trials network will be indispensable as we advance this therapy.”
In other recent news, Anthera announced that it partnered with Patheon®, a contract development and commercial manufacturing (CDMO) service provider in order to manage the SOLUTION trial. The study will evaluate 126 CF patients.