AstraZeneca squares off against Roche in blockbuster PhIII asthma showdown

AstraZeneca ($AZN) has launched a Phase III test of its targeted IL-13 asthma drug tralokinumab, beefing up its late-stage pipeline for respiratory diseases and squaring off against some major league competition now in the clinic.

The antibody, which targets a cytokine that is believed to play a big role in spurring severe asthma, emerged from AstraZeneca's U.S. subsidiary MedImmune. It's also currently in a mid-stage study for idiopathic pulmonary fibrosis.

But AstraZeneca faces some heavyweight competition in the clinic. Back in March Roche ($RHHBY) heralded upbeat Phase IIb data for its IL-13 antibody lebrikizumab, which CEO Severin Schwan picked back in 2011 as one of three big prospective blockbusters in the pipeline. That drug is headed for a 2016 rendezvous with regulators. Receptos ($RCPT), meanwhile, in-licensed an IL-13 drug from AbbVie ($ABBV) after the pharma company decided to de-prioritize its respiratory efforts, including a program for asthma. Receptos is testing RPC4046 for Eosinophilic esophagitis, an orphan disease, and AbbVie has an option to buy it back.

Back in March Roche highlighted the potential of its treatment, posting data which demonstrated that the drug cut the rate of asthma attacks among patients with a high level of the protein periostin by an average of 60%, with the low-dose arm hitting an 81% drop in attack rates. Among patients with low periostin the attack rate dropped only 5%.

AstraZeneca badly needs all the most promising late-stage studies it can squeeze into the pipeline. In addition to trying to reform its rep for drug development, squandered on bad bets by former CEO David Brennan, the company is still frequently mentioned as a takeover candidate for a struggling Pfizer ($PFE).

According to, AstraZeneca's Phase III study has a primary completion date of June, 2017, which would place it well behind Roche. Roche has posted a slate of 8 ongoing studies with the most advanced reporting data in late 2015. A separate Phase III asthma study at AstraZeneca is slated to wrap in August, 2017.

"Patients with severe asthma currently have limited treatment options and need more effective therapies to control their disease," says Bill Mezzanotte, vice president and head of inflammation, neuroscience and respiratory for AstraZeneca, in a statement. "The development of tralokinumab underscores our commitment to a personalized treatment approach for these patients, to improve their lives. Severe asthma is highly heterogeneous; we are working to better understand patient subtypes, identify potential biomarkers, and tailor therapies to cellular and molecular phenotypes to achieve the best clinical outcomes."

- here's the release