Roche says that its investigational asthma treatment lebrikizumab has impressed in a mid-stage study and merits further investigation.
Lebrikizumab is a humanised monoclonal antibody designed to block interleukin-13, a contributor to asthma which increases periostin, a protein which can be measured with a blood test. The drug met its primary endpoint in a 219-patient Phase II study, called MILLY, by demonstrating a statistically significant increase in FEV1 (the volume of air that can be forced out in one second after taking a deep breath) in adults with asthma whose symptoms were inadequately controlled with inhaled corticosteriods.
The data, which has been published in the New England Journal of Medicine, showed that at week 12, lebrikizumab-treated patients had a 5.5% greater increase in pre-bronchodilator FEV1 than placebo, while patients on the Roche drug in the high-periostin subgroup experienced an 8.2% increase in lung function compared with placebo; the low-periostin subgroup experienced a 1.6% rise in FEV1.
The Swiss major added that although the study was not powered to detect it, there was a trend towards a lower rate of severe exacerbation in patients treated with lebrikizumab.
Richard Scheller, head of research and early development at Roche’s Genentech unit, said “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,” He added that these results support further investigation of the drug as a personalised medicine for patients who suffer from moderate to severe uncontrolled asthma”.
