Tozorakimab, an investigational biologic therapy, reduced moderate-to-severe COPD exacerbations by 29-34% compared to placebo in two phase 3 clinical trials, with a safety profile comparable to placebo, and is now under FDA consideration for approval.
- Efficacy: Tozorakimab reduced annualized moderate-to-severe exacerbations by 29-34% across both OBERON and TITANIA trials compared to placebo
- Trial Details: Two replicate phase 3 trials enrolled nearly 1,750 adults with COPD who were current or former smokers with prior exacerbations despite standard treatment
- Dosing: Patients received add-on subcutaneous tozorakimab or placebo injections every four weeks for 52 weeks
- Safety: Overall safety profile was similar to placebo with comparable rates of adverse events; injection-site reactions occurred more frequently with tozorakimab
- FDA Status: Study results are under FDA consideration for approval to use tozorakimab in qualifying patients outside clinical trials
An investigational biologic therapy for COPD has shown promising results in two clinical trials. Researchers from the University of Pittsburgh reported that tozorakimab significantly reduced flareups among patients already receiving standard treatment for the disease.
The paper, “Tozorakimab to Prevent COPD Exacerbations,” was published in the New England Journal of Medicine.
The researchers outlined two replicate phase 3 trials, OBERON and TITANIA, that enrolled adults with COPD who were current or former smokers and had a history of exacerbations in the previous year despite receiving stable standard-of-care inhaled maintenance therapy.
Patients were randomly assigned to receive add-on subcutaneous tozorakimab or placebo every four weeks for 52 weeks. The primary endpoint was the annualized rate of moderate or severe exacerbations that occurred over a 52-week period among former smokers.
The overall population for the OBERON trial included 446 patients in the tozorakimab group and 431 in the placebo group. For TITANIA, it was 438 in the tozorakimab group and 435 in the placebo group. In OBERON, the tozorakimab group had an annualized rate of moderate or severe exacerbations among former smokers of 1.34, while the placebo group had 1.90. In the TITANIA trial, the tozorakimab group had an annualized rate of 1.37 events compared to 2.07 for the placebo group.
Across both studies, the researchers concluded that patients receiving tozorakimab experienced approximately 29%-34% fewer moderate-to-severe COPD exacerbations compared to those receiving placebo. Unlike existing biologics for COPD, the effect was clinically impactful across all levels of eosinophils.
“Reducing exacerbations is one of the most important goals in the treatment of COPD because flareups have a profound impact on patients’ health, quality of life and long-term outcomes,” said co-lead author Frank Sciurba, MD, in a press release. “The results of this trial suggest an important new strategy for reducing the burden of COPD exacerbations.”
The studies also found that tozorakimab’s overall safety profile was generally similar to placebo. Investigators reported comparable rates of adverse events and serious adverse events between treatment groups. Injection-site reactions occurred more frequently among those receiving tozorakimab.
“Our study data and results will now be under consideration by the U.S. Food and Drug Administration for approval to use [tozorakimab] in qualifying patients outside of a clinical trial,” said Dr. Sciurba, who is professor of medicine in the division of pulmonary, allergy, critical care and sleep medicine at Pittsburgh University. “It is encouraging to have an additional, safe therapy for patients who often struggle to breathe.”
