AstraZeneca's respiratory biologic drug fails COPD trial

AstraZeneca's late-stage Galathea trial for its first respiratory biologic drug failed to meet its primary goal in treatment of chronic obstructive pulmonary disease.

The FTSE 100 drugmaker said it will await the results of a sister trial, Terranova, and a full evaluation of both trials to determine next steps for Fasenra in COPD.

Galathea and Terranova are both Phase III trials carried out over 56 weeks across multiple medical centres to assess the safety and efficacy of Fasenra as an add-on to dual- or triple-inhaled therapy compared to placebo in patients with moderate to very severe COPD with a history of exacerbations. COPD is predicted to be the third-leading cause of death by 2020 and between 30-40% of moderate to severe sufferers already on triple-inhaled therapy remain uncontrolled and continue to experience exacerbations.

However, in the Galathea trial, Fasenra, which is AstraZeneca's first respiratory biologic drug and is already widely approved for forms of severe asthma, did not meet the primary endpoint of a statistically-significant reduction of exacerbations.

Astra did not report the precise impact of Fasenra in the trial but said it would present further results at a forthcoming medical meeting.

Chief medical officer Sean Bohen said: "COPD is a debilitating disease with significant unmet need among patients whose disease remains uncontrolled despite treatment with existing inhaled therapies. We will now await the results of TERRANOVA and a full evaluation of both trials to determine next steps for Fasenra in COPD."

Fasenra is the brand name for benralizumab, a monoclonal antibody developed by Astra's MedImmune arm that 'recruits' the body's killer cells to induce rapid and near-complete depletion of eosinophils, a type of white blood cell that are a normal part of the body's immune system. The results of the Galathea trial do not impact the approved indication in severe eosinophilic asthma.

Analyst Tara Raveendran at Shore Capital noted that Astra's rival GSK has previously reported mixed results for its respiratory biologic Nucala in patients with COPD and an eosinophilic phenotype in the Mextrex and Metreo trials, with the former showing a statistically significant reduction in the frequency of moderate and severe exacerbations in patients with a higher eosinophil count, and the latter showing no significant effect on exacerbations. GSK submitted the drug for regulatory review in November 2017 and is awaiting a decision from the US FDA.

"Of note, Astra has not reported the impact of Fasenra stratified by eosinophil count at the current time but plans to present further results at a forthcoming medical meeting," she said. "We believe that data stratified according to blood eosinophil count will provide further important insights regarding the therapeutic potential of Fasenra in COPD."

AZN shares were little moved on Friday, down 0.7% to 5,213p in early trading.