BioWorld International Correspondent
Fibrex Medical Inc. may be on the fast track to a blockbuster. The company raised $10 million in its Series A investment round this week, and it plans to have its lead compound in clinical testing by the third quarter.
The compound, designated FX06, is a small peptide that the company believes will be helpful in preventing reperfusion injury, or additional damage to the heart muscle stemming from the re-establishment of bloodflow, after myocardial infarction.
"Even a conservative estimate of 10 percent market penetration in the big three markets, Europe, the U.S. and Japan, would yield annual sales figures in the range of $800 million to $1 billion," Rainer Henning, Fibrex's CEO told BioWorld International.
"The peptide would be used for acute treatment at the time of reperfusion," Henning said. "Thus it would only be necessary to apply once, which would be done intravenously during the intervention procedure. We think it would work equally well with either a balloon catheter or bypass surgery, the two standard procedures."
The company's preliminary preclinical results are published in the March 2005 issue of Nature Medicine.
"A lot of damage [after a heart attack] is done by leukocytes that move out of the bloodstream into the heart tissue," Henning said. "The drug prevents the white cells' final penetration of heart tissue through a novel mechanism."
According to the company's study, FX06 competes with a particular fibrin fragment for binding to vascular endothelial cadherin, which prevents leukocytes from migrating across one-cell-deep endothelial layers.
"The peptide is a naturally occurring sequence that inhibits the interaction of fibrin fragments with white blood cells and a newly discovered receptor," Henning said.
Fibrex plans to move rapidly into clinical trials, beginning Phase I trials in the third quarter and Phase II studies in the second quarter of 2006.
"We hope to reach clinical proof of concept in a two-year time frame," he said. "This round of funding will carry us all the way through."
Although Fibrex Medical Inc. is based in Wilmington, Del., the operational part of the company is based in Vienna, Austria.
"For the future of the business, we decided to create [the U.S. unit] as a financial holding company, with [the Austrian company] as a wholly owned subsidiary and operational unit," Henning said. "The operations will take place in Vienna."
Once it has proved its clinical concept, Fibrex will need a partner to take the candidate through registration. "With a product like that, we cannot take it into large-scale clinical trials ourselves," Henning said.
While concentrating on advancing the potential blockbuster as rapidly as possible, Henning said that the company also will be looking to broaden its research pipeline with candidates for acute cardiovascular indications and other anti-inflammatory compounds.