AstraZeneca’s chronic obstructive pulmonary disease (COPD) candidate has served up a third phase 3 win this year, offering further evidence the Big Pharma may have cracked the anti-IL-33 code.
The latest late-phase study, dubbed Miranda, evaluated 300 mg tozorakimab or placebo dosed every two weeks for a year in 1,451 patients with COPD who were still experiencing moderate-to-severe exacerbations despite being on inhaled standard of care.
The study demonstrated a statistically significant reduction in the annualized rate of moderate-to-severe COPD exacerbations in both former smokers and in the overall population, hitting the trial’s primary and secondary endpoints, respectively. While AstraZeneca said it will share the data with regulators, the company is holding back the findings from the public until a future medical meeting, according to the April 20 release.
During the trial, tozorakimab was generally well tolerated, with a favorable safety profile consistent with previous studies, according to the drugmaker.
The latest readout follows a pair of phase 3 COPD successes for tozorakimab last month. Those wins reignited hopes for the modality after Sanofi and Regeneron’s itepekimab and Roche’s astegolimab, both of which block IL-33 signaling, failed their own trials.
Despite skepticism about whether any IL-33 inhibitor could deliver the goods, AstraZeneca had maintained that tozorakimab is a differentiated asset that could one day deliver peak sales of $3 billion to $5 billion.
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Unlike itepekimab and astegolimab, AstraZeneca’s candidate completely inhibits the ST2 and RAGE/EGFR signaling cascades. RAGE/EGFR affects mucus production, which drives exacerbations, and the epithelial remodeling that decreases lung function in COPD patients.
“These data further demonstrate tozorakimab’s exciting potential as a first-in-class biologic with a truly differentiated mechanism of action that inhibits the signalling of the reduced and oxidised forms of IL-33 to address underlying drivers of COPD,” Sharon Barr, head of BioPharmaceuticals R&D at AstraZeneca, said in Monday’s release.
“We look forward to sharing the data with regulators and the scientific community as soon as possible,” Barr added.
As well as the trio of phase 3 COPD wins, AstraZeneca is also studying tozorakimab in a late-stage study for severe viral lower respiratory tract disease and a phase 2 trial in asthma.
