Pharmaceutical Business review

Protea Biosciences, Mayoly-Spindler Jointly Initiate Lipase Phase I/IIA Clinical Trial

The clinical trial is expected to be held at the Hospital ‘la Timone’ in Marseilles, France. The aim of the clinical trial is to show safety and proof-of-concept data for the recombinant lipase as treatment for chronic pancreatitis.

Under terms of their partnership agreement, Protea has got an exclusive marketing rights for the recombinant Lipase in North America from Mayoly-Spindler .

Steve Turner, CEO of Protea, said: “In extensive preclinical studies, our Lipase was shown to be fifty times more active than currently available products. The challenge has been to find a lipase that will be active in the harsh environment of the GI tract where you have low pH, protein degradation, and the presence of bile salts. Discovered in a French government laboratory, we believe this recombinant Lipase is the best one ever to be produced. “

Jean-Nicolas Vernin, CEO of Mayoly-Spindler, said: “We strongly believe that such a product could have a significant improvement for the treatment of Exocrine Pancreatic Insufficiency.”