Roche Announces Positive Clinical Trial Data for Lebrikizumab

Mid-stage clinical data for Roche’s asthma drug, lebrikizumab, has demonstrated that the drug significantly reduced attacks in patients with severe uncontrolled asthma.

Roche presented the Phase IIb clinical data at the American Academy of Allergy, Asthma and Immunology meeting in San Diego yesterday.

The data from the clinical trials showed that asthma attacks were reduced by 60% more than a placebo, in lebrikizumab-treated patients with a high level of the biomarker periostin.

In comparison, the drug reduced asthma attacks in 5% of patients with a low level of the protein.  The results also showed that in patients with high periostin levels, lebrikizumab improved lung function.

Commenting on the results Dr Nicola Hanania, one of the study’s lead investigators, noted that if the drug was approved patients “would have for the first time a personalized approach other than just blanket therapy for everyone with uncontrolled disease.”

Roche noted that the use of periostin as a biomarker provides a personalised healthcare approach in asthma and will be further evaluated in ongoing clinical trials.

Lebrikizumab is designed to specifically block the action of interleukin-13, a cytokine that contributes to airway inflammation and asthma disease process in some patients.  Blocking this cytokine and measuring periostin with a blood test may predict which patients with severe uncontrolled asthma could benefit.

Interestingly, the greatest level of asthma attack reduction, at 81%, was seen with patients given the lowest dose of lebrikizumab, showing that a higher dose doesn’t always lead to better results.

Lebrikizumab is currently being evaluated in adults with severe uncontrolled asthma in two Phase III clinical studies and is in seven ongoing or planned trials, including one for idiopathic pulmonary fibrosis.

Roche concluded by noting that if the results are replicated in ongoing Phase III clinical trials, they will expect to seek for regulatory approval in 2016.


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