AstraZeneca's (LSE:AZN) tozorakimab met the primary endpoint in the pivotal Phase III MIRANDA trial, producing a "statistically significant and clinically meaningful reduction in the annualised rate of moderate‑to‑severe COPD exacerbations" in former smokers and in the overall population of former and current smokers. Patients received tozorakimab 300mg or placebo on top of standard‑of‑care inhaled therapy every two weeks for 52 weeks.
"These results add to the growing body of evidence that indicates tozorakimab delivered meaningful clinical benefits for COPD patients who urgently need new treatment options. Up to half of patients today still experience exacerbations even when taking standard‑of‑care inhaled therapies, putting them at risk of serious health consequences including hospitalisation and even death." Frank Sciurba, MD, FCCP, Professor of Pulmonary and Critical Care Medicine, University of Pittsburgh, Chief Investigator of LUNA programme said.
MIRANDA is the third positive pivotal trial in AstraZeneca (LSE:AZN)'s Phase III LUNA programme, following the March announcements of high‑level positive results from OBERON and TITANIA, which tested the same 300mg dose at a four‑week interval across 2,306 randomised patients. Tozorakimab was generally well tolerated in MIRANDA with a safety profile consistent with prior studies. AstraZeneca said it will submit the data to regulators and present full results at an upcoming medical meeting.
