The UK pharma’s antibody, tralokinumab, has failed to meet its primary endpoint in Phase III of reducing asthma. This result was “widely expected.”

Asthma, which affects 1 in 12 Americans and costs their country $56B annually, is a highly competitive market with Chiesi and Novartis also racing for the next blockbuster treatment. Despite this heat and uninspiring Phase II results — including a failed Phase IIb trial — AstraZeneca decided to press on to Phase III with tralokinumab. It didn’t come as a shock when the pharma announced it had missed its primary endpoint today.

Tralokinumab is a monoclonal antibody target interleukin-13 (IL-13), which inhibits inflammatory cytokine production to regulate inflammatory and immune responses like asthma attacks. The drug’s goal was to significantly reduce the annual severe asthma exacerbation rate in two Phase III trials.

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It failed to demonstrate efficacy against a placebo in this first trial, but a second one designed to validate a biomarker associated with IL-13 is ongoing. The failure comes as bad news, but perhaps because it was anticipated, the pharma’s stock price hasn’t been dented since the announcement.

This may be the end of the road for the antibody in asthma, leaving the fight up to AstraZeneca’s other asthma candidate, benralizumab. Its main competitors are Chiesi and Novartis; the Italian pharma recently acquired Atopix Therapeutics to bolster its pipeline, but Novartis remains in the lead with a Phase III candidate scheduled to launch in 2019.

But tralokinumab presses on in atopic dermatitis. AstraZeneca recently sold its rights in the indication to Leo Pharma, based near Copenhagen in Denmark, for €100M. The company specializes in dermatology, so despite the drug’s failure in respiratory disease, it may still have hope in this ever-competitive field.


Images from BlueRingMedia, Tikhomirov Sergey / shutterstock.com

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