Roche reported Thursday that a mid-stage trial of its experimental antibody lebrikizumab met its main goal, demonstrating a statistically significant increase in lung function in adults with asthma. In addition, the company noted that patients with high levels of the protein periostin had greater improvements in lung function when treated with the drug compared to those with low levels.
"The findings of the MILLY study, and the development of a potential biomarker, have shown that we may be able to select appropriate asthma patients for lebrikizumab therapy," remarked Richard Scheller, executive vice president of research and early development at Roche's Genentech unit. "These results support further investigation of lebrikizumab as a personalised medicine for patients who suffer from moderate to severe uncontrolled asthma," he added.
The study randomised 219 patients with asthma whose symptoms were inadequately controlled with inhaled corticosteriods to receive lebrikizumab dosed every 28 days for a total of six doses or placebo. Results of the study, which have also been published in the NEJM, showed that at week 12, patients who received Roche's drug had a 5.5-percent greater increase in a measure of lung function from baseline compared to those who took placebo.
According to the drugmaker, patients with high levels of periostin who received lebrikizumab had an 8.2-percent greater increase in the same measure of lung function compared to placebo, versus 1.6 percent for those in the low-level group. Roche also said that the study data showed a "trend towards" a lower rate of severe asthma attacks in patients treated with the antibody, although the company noted the trial wasn't designed to detect a reduction of these.
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