First personalised asthma drug shows promise
pharmafile | August 4, 2011 | News story | | Roche, asthma, personalised medicine
Roche’s personalised asthma drug lebrikizumab has met its primary end point in a phase II trial.
Lebrikizumab increased the level of lung function in adult asthma patients who were unable to control their disease on inhaled corticosteroids compared to placebo.
The drug, an injectable humanised monoclonal antibody, is designed to block interleukin-13 cytokine, a key contributor to the features of asthma.
The study found that interleukin-13 cytokine increases periostin, a protein that can be measured in the blood.
In the MILLY trial, patients with high pre-treatment periostin levels had greater improvement in lung function when treated with lebrikizumab, compared to patients with low periostin levels.
This biomarker allows patients to be screened to see which will benefit most from the drug.
Richard Scheller, executive VP of Roche’s biologics arm Genentech, explained: “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.
“These results support further investigation of lebrikizumab as a personalised medicine for patients who suffer from moderate to severe uncontrolled asthma.”
The primary endpoint of the trial showed that at week 12, lebrikizumab-treated patients had a 5.5% greater increase in lung function (pre-bronchodilator FEV1), from the baseline compared to placebo.
Lebrikizumab-treated patients in the high-periostin subgroup experienced an 8.2% relative increase from baseline FEV1, compared with placebo.
In the low-periostin subgroup, those patients on the drug experienced a 1.6% relative increase in FEV1, compared with placebo.
Side effects were similar across both arms of the study, with respiratory and sinus infections the most frequent adverse events in the trial. Full trial data is available from the New England Journal of Medicine.
Ben Adams
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