PARIS (dpa-AFX) - Regeneron Pharmaceuticals Inc. (REGN) and French drug major Sanofi S.A. (SNYNF,SNY) announced Friday that Itepekimab met the primary endpoint in one of two trials of chronic obstructive pulmonary disease or COPD, while the second trial failed to meet the main goal.
The companies said they are reviewing the trial data and will discuss with regulatory authorities to evaluate next steps.
A Phase 3 trial, AERIFY-1, evaluating the investigational use of itepekimab in adults who were former smokers with inadequately controlled COPD met the primary endpoint of significantly reducing moderate or severe acute exacerbations by 27% compared to placebo at week 52, a clinically meaningful benefit.
Meanwhile, a second Phase 3 trial, AERIFY-2, did not meet the same primary endpoint, although a benefit was seen earlier in the trial.
The companies noted that AERIFY-1 trial met the primary endpoint in moderate or severe exacerbations in former smokers regardless of eosinophilic phenotype.
Itepekimab was generally well tolerated in both AERIFY-1 and AERIFY-2, with safety consistent with prior clinical trials.
AERIFY-1 and AERIFY-2 are randomized, Phase 3, double-blind, placebo-controlled trials that evaluated the efficacy and safety of itepekimab in 1,127 adults aged 40-85 years in the first trial and 953 adults in the second trial, who were former smokers with moderate-to-severe COPD. Former smokers were defined as those who have not smoked for at least six months.
In the trials, patients were randomized to receive itepekimab every two weeks, every four weeks, or placebo, which was added to inhaled triple or double standard-of-care therapy. The primary endpoint for AERIFY-1 and AERIFY-2 was the reduction in the annualized rate of acute moderate or severe COPD exacerbations with itepekimab treatment.
The companies noted that a formal significance testing was only performed at 52 weeks in the Phase 3 trials, with significance achieved for both the every-two-week arm and every-four-week arm in AERIFY-1.
Meanwhile, the total number of exacerbations was lower than prospectively anticipated, decreasing the power of both trials, they said. Enrollment largely occurred during the time of the global COVID-19 pandemic, which could have contributed to the lower overall exacerbation rates.
George Yancopoulos, Board co-Chair, President and Chief Scientific Officer at Regeneron, said, 'We are encouraged by the overall results from AERIFY-1 and the data through week 24 for AERIFY-2 and are reviewing the results from both itepekimab trials to inform next steps. We remain committed to our broader itepekimab development program and learnings from the AERIFY program will be invaluable as we continue to advance itepekimab in respiratory diseases with unmet need.'
The companies plan to present detailed results from these trials at a future medical meeting.
Itepekimab, which was invented using Regeneron's proprietary VelocImmune technology, is a fully human monoclonal antibody. Regeneron and Sanofi jointly develop Itepekimab under a global collaboration agreement. The drug is currently being evaluated in other trials, including chronic rhinosinusitis without nasal polyps, chronic rhinosinusitis with nasal polyps and non-cystic fibrosis bronchiectasis.
The drug's safety and efficacy are currently under clinical investigation and have not been fully evaluated by any regulatory authority, the firms added.
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