San Francisco's KaloBios ($KBIO) is hitting the brakes on one of its lead programs after the asthma treatment missed its primary endpoint in a mid-stage trial, sending the company's shares into a 30% tailspin.
The drug, KB003, failed to significantly improve lung function in patients with severe asthma in a Phase II study, KaloBios said, and while the antibody proved generally safe and well-tolerated in the 160-patient trial, the company doesn't see much of a way forward.
"We are obviously disappointed in this outcome given the unmet need for additional treatments for severe asthma," CEO David Pritchard said in a statement. "Based on the initial data evaluation of this Phase II study, we are discontinuing clinical development of KB003 in severe asthma."
With KB003 on the sideline, KaloBios is pushing ahead with KB001-A, an antibody fragment targeting the bacterium Pseudomonas aeruginosa (Pa). The biotech is partnered up with Sanofi ($SNY) to develop the drug for Pa-related pneumonia with an FDA fast-track designation to boot, and KaloBios is in the midst of a Phase II study of its own to test KB001-A on cystic fibrosis patients with chronic Pa. The biotech also has a Phase I asset to treat blood cancers and solid tumors.
KaloBios was among the early entrants in 2013's flurry of biotech IPOs, but the demise of its most promising asset sent its share price down to around $3.35 in premarket trading Thursday, a 60% drop from its $8-a-share debut last year. The company, a 2009 Fierce 15 honoree, raked in about $70 million through its Wall Street entrance but has never been able to match its initial pricing.
- read the release
Special Report: 2009 Fierce 15 - KaloBios