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Asthma candidate reaches primary endpoint

The humanised monoclonal antibody lebrikizumab, Roche’s investigational personalised asthma treatment, has met the primary endpoint of its phase II trial
 Roche has announced that MILLY, a phase II study of its investigational asthma treatment lebrikizumab, has reached its primary endpoint of creating a statistically significant increase in lung function in adults with uncontrolled asthma. 

Lebrikizumab, which was first developed by Genentech Research and Early Development (gRED), is a humanised monoclonal antibody designed to reduce inflammation in the lungs and block interleukin-13 (IL-13) cytokine, a key contributor to asthma. IL-13 increases the levels of the protein periostin: patients with higher levels of this protein before receiving lebrikizumab treatment responded better to the therapy than patients with low periostin levels, showing greater improvements in Forced Expiratory Volume 1 (FEV1) lung function. 

Lebrikizumab has the potential to become the first personalised treatment for asthma, as identifying patients with high periostin levels will indicate which are most suitable for lebrikizumab treatment. 

Richard Scheller, executive vice president of gRED, said: “These results support further investigation of lebrikizumab as a personalised medicine for patients who suffer from moderate to severe uncontrolled asthma.” 

The trial randomised 219 patients into two treatment groups: 106 patients received lebrikizumab, 112 patients received placebo and one patient was not treated. Patients in the active treatment group received a total of six doses of lebrikizumab, receiving one 250mg dose subcutaneously every 28 days. 

In the study, treatment with lebrikizumab was associated with a statistically significant increase in FEV1 in adults with asthma whose symptoms were inadequately controlled with inhaled corticosteroids (ICS) after 12 weeks of treatment. The overall frequencies of both adverse events and serious adverse events were similar in the placebo group compared with the treatment group, with the most common adverse events being infections (including upper respiratory infections and sinus infections). Additionally, patients treated with lebrikizumab appeared to have a lower rate of asthma exacerbations, though the study had not been designed to measure this.  

The results of the MILLY study – a global phase II randomised double-blind placebo-controlled study evaluating safety, tolerability and efficacy of lebrikizumab in adult uncontrolled asthma patients, sponsored by Roche and Genentech – are to be published in the New England Journal of Medicine.

8th August 2011

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