AstraZeneca rises 3.5% as its lung disease drug unexpectedly succeeds in clinical trials (competitors have all failed)

Key takeaways

• The company with the highest market value in the UK said its investigational lung disease drug achieved the primary endpoint in two Phase 3 clinical trials.
• AstraZeneca said that its respiratory drug tozorakimab, compared with placebo, reduced acute exacerbations of chronic obstructive pulmonary disease in both prior smokers and the overall patient population.
• Analysts said that after competing drugs in the same category failed one after another, this result signals a clear shift in market sentiment.

The UK’s highest-market-value company AstraZeneca announced that after its investigational lung disease drug met its pre-set goals in two Phase 3 clinical trials, the stock price surged by nearly 5% at one point.

The company said that tozorakimab, its investigational respiratory drug, compared with placebo, was effective in reducing acute exacerbations of chronic obstructive pulmonary disease (COPD) in both prior smokers and all enrolled patients.

A Jefferies analyst noted: “Given that the IL-33-targeting drugs from Sanofi and Roche previously all failed, the market lacked confidence in this mechanism of action. Now, this result marks a significant shift in market sentiment.”

Tozorakimab is in the same monoclonal antibody drug class as competing drugs. It works by suppressing the activity of the interleukin-33 (IL-33) protein to alleviate inflammatory responses.

Sharon Ball, Executive Vice President for Biopharmaceuticals and R&D at AstraZeneca, said: “Today’s announcement of the results from two confirmatory Phase 3 clinical trials for tozorakimab represents the first successful breakthrough in the field of IL-33 biologics, and is a major scientific advance in treating COPD—one of the world’s top three causes of death.”

Ball added: “The mechanism of action of tozorakimab is fundamentally different from other biologics. It can simultaneously inhibit signal transduction of both the reduced and oxidized forms of IL-33, reducing inflammation while also breaking the core pathological cycle in COPD—mucus dysfunction.”

AstraZeneca said that the complete trial data will be released at an upcoming medical conference.

In July this year, Swiss pharma company Roche released its Phase 3 clinical results for its COPD drug astegolimab, which fell short of expectations. In the end, it failed to reduce acute exacerbations. The drug has a similar mechanism to tozorakimab and is also designed to block IL-33 binding.

Two months earlier, in the prior period, France’s Sanofi and its partner Regeneron jointly developed drug itepekimab, which also released similarly unfavorable data.

AstraZeneca’s shares listed in New York rose against the trend by 3.5% in early trading. Driven by AstraZeneca’s Friday news, Roche and Sanofi shares each rose by about 1%.

Potential of the multi-billion-dollar market

According to World Health Organization data, nearly 400 million people worldwide have been diagnosed with COPD, which is also one of the leading causes of death globally.

COPD is a progressive respiratory disease, mainly characterized by shortness of breath, chronic cough, and excessive mucus production. Symptoms worsen over time, continuously triggering inflammation and bronchial constriction, leading to breathing difficulties and increasing the risk of acute exacerbations.

According to FactSet data, AstraZeneca expects the peak annual sales of tozorakimab to be between $3 billion and $5 billion; before the trial results were released on Friday, the market’s average expectation for its peak sales was only about $1 billion.

The trial results showed that the drug was effective in both prior smokers and current smokers, as well as in patients across different severities of lung function impairment.

Citi analyst pointed out that the drug is also effective in patients with low levels of eosinophils, a group that makes up about 35% of COPD patients and represents a long-unmet clinical need.

Tozorakimab is currently also being studied in Phase 3 clinical trials for severe viral lower respiratory tract infections, as well as in Phase 2 clinical trials for asthma.

AstraZeneca plans to launch more than 20 new drugs over the next five years, with a target of $80 billion in annual sales by 2030.

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责任编辑：郭明煜