Dive Brief:
- AstraZeneca said Friday its experimental antibody drug tozorakimab met its main goal in two Phase 3 trials in chronic obstructive pulmonary disease, helping reduce flare-ups in a broad range of people with the condition.
- The data could help AstraZeneca’s drug reach more patients than the currently available biologics for COPD, Dupixent and Nucala, both of which are limited to those with high levels of white blood cells called eosinophils. The U.K.-based drugmaker said the trials “included former and current smokers, and patients across all blood eosinophil counts and all stages of lung function severity.”
- Success in the two studies came as a surprise to Wall Street analysts, as similarly acting drugs from Roche, as well as partners Regeneron and Sanofi, have faced setbacks or failed outright in late-stage testing. An approval could help AstraZeneca’s ambitions to reach a record $80 billion in revenue by 2030, as executives have estimated tozorakimab could generate $3 billion to $5 billion in annual sales at its peak.
Dive Insight:
AstraZeneca didn’t release complete data from the trials, called Oberon and Titania, stating that they will be disclosed at an upcoming medical meeting.
Those details will be closely watched. Regeneron and Sanofi’s Dupixent is one of the world’s top-selling medications, and its 2024 approval in COPD has helped meaningfully broaden use. GSK’s Nucala has since joined it on the market. Yet drugs like tozorakimab work differently, blocking a protein called IL-33 that triggers immune responses.
By inhibiting IL-33, tozorakimab is thought to be able to reduce inflammation as well as the buildup of sticky mucus that can obstruct airways and trigger flare-ups in people with COPD. It also, notably, has the potential to help a wider group of people with the condition. Yet the disappointing results from IL-33 blockers so far led analysts to question the approach.
AstraZeneca’s apparent success may be a result of a slight difference in its mechanism, wrote Jefferies analyst Michael Leuchten. The drug aims at a “reduced” form of the protein which doesn’t interact with another inflammatory molecule. It also only acts on cells that line the respiratory system, Leuchten added.
Leuchten additionally noted how, if approved, tozorakimab “could more than double the eligible biologics population to nearly 80%, while also potentially competing with Dupixent” in people with eosinophilic COPD.
“These trial results suggest that targeting the IL-33 pathway with tozorakimab delivers meaningful clinical benefit in a trial representing a broad COPD population, independent of smoking status and eosinophilic levels,” said Frank Sciurba, a University of Pittsburgh professor of pulmonary care, in a statement provided by AstraZeneca.
In the trials, investigators had enrollees with COPD flare-ups in the preceding 12 months take tozorakimab in addition to standard inhaled therapy for a year. They evaluated whether those participants had fewer flare-ups, on average, than enrollees who took their standard inhaled therapy plus a placebo.