Alnara Pharma Completes Key Cystic Fibrosis Drug Trial, “Extremely Encouraged” by Results

5/28/09

Alnara Pharmaceuticals won’t likely reveal the full results of its late-stage clinical trial of enzyme-replacement drug liprotamase in patients with cystic fibrosis until this fall, but the Cambridge, MA-based biotech firm has completed the trial in recent weeks and continues to find the effectiveness of the treatment “extremely encouraging,” Robert Gallotto, chief business office of Alnara, tells Xconomy.

Gallotto isn’t disclosing detailed results of the key trial, designed to form the basis of an application for approval of liprotamase, so it’s too early to say whether the study was a success. Yet he indicates that he and others at Alnara are pleased with the results of the trial, which ended several weeks ago when the last of 145 patients involved in the trial received a final examination. He expects the full results of the trial to be reported during the Annual North American Cystic Fibrosis Conference in October. (The drug already showed positive effects in cystic fibrosis patients in a separate late-stage study reported last year, and it wouldn’t be a big surprise to see similar results in the larger trial that was just completed.)

“We are extremely encouraged with what we’ve seen,” Gallotto says. “The data continues to be encouraging and we look forward to sharing it in its totality sometime in the fall.”

Liprotamase became the No. 1 drug in Alnara’s pipeline in March, when the young biotech startup gained control of the treatment in a licensing deal with a nonprofit affiliate of the Cystic Fibrosis Foundation, of Bethesda, MD. The drug replaces a pancreatic enzyme for absorbing nutrients that is lacking in patients with diseases such as cystic fibrosis, a genetic disorder that results in lung infections and digestive problems. Gallotto and Alnara CEO Alexey Margolin were also intimately involved in the development of liprotamase in their former jobs as executives at Cambridge, MA-based Altus Pharmaceuticals (NASDAQ:ALTU), which discovered the drug but ended its program to develop it in January due to financial constraints. That prompted the CF Foundation, which had provided funding for Altus to develop the drug, to take over the program from Altus.

The latest clinical trial of liprotamase—which previously showed promising results in studies involving patients with chronic pancreatitis and other pancreatic disorders—was designed to test the … Next Page »

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