Drug Development

Aviragen shares plunge as RSV antiviral flunks a small PhIIa study

The antiviral biotech Aviragen $AVIR says that its experimental RSV therapy BTA585 flunked a small Phase IIa study in volunteers who had been intranasally infected with the virus.

Only about 20 patients were recruited for the study. Divided into three cohorts, two received different doses of BTA585 and the third was treated with a placebo. The primary endpoint was viral load with some secondary endpoints on the severity of RSV disease as measured by 10 RSV-related clinical symptoms and mucus weight.

Like a lot of small biotechs – Atlanta-based Aviragen has a market cap of about $47 million – the setback routed the stock. Shares slid more than 20%.

Investigators reported that “subjects receiving 400 mg (n=13) or 600 mg (n=12) BTA585 had least square means for viral loads of 484.6 and 534.9, respectively, compared to the placebo viral loads of 552.9 (n=13).”

“We’re in the early stages of assessing the available data from the study. On a positive note, there were no safety signals observed for BTA585 compared to placebo.  We also observed biological activity in several of the endpoints, however, the considerable variability in viral load among the cohorts and the small number of subjects that became infected with RSV likely impacted the ability to detect a significant difference between the groups,” noted Aviragen CEO Joseph M. Patti. “We plan to analyze the full data set once it becomes available and communicate our plan for this program in the second quarter of 2017.”


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