Neither of the two doses in the study – 264 mg or 528 mg – achieved a statistically significant outcome on the primary endpoint.
Just days ago in a Q2 call CEO Joseph Patti called this drug the biotech’s most advanced anti-viral.
“Moderate-to-severe asthmatics who have a history of their asthma worsening with an upper respiratory infection are randomized into the trial when they are experiencing a symptomatic rhinovirus infection,” he told investors. “As you may recall the primary endpoint this SPIRITUS trial is a change from baseline to study day 14 measured by a patient reported asthma control questionnaire ACQ-6 total score.”
The news comes just days after the company reported that BTA585 flopped in a small Phase IIa trial for RSV. And investors were not in a forgiving mood. The biotech’s stock plunged 48%, leaving it in penny stock territory at around 56 cents a share.
“We are disappointed that the SPIRITUS trial did not meet its primary endpoint in this patient population. There was evidence of an antiviral effect in patients that received vapendavir within the first day following the onset of their symptoms, and as such, we plan to take time to fully analyze the data before making a decision on whether to initiate a study in hematopoietic stem cell transplant patients, where the ability to stop the progression of the RV infection could be beneficial,” Patti said in a prepared statement.
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