Roche reports mixed data of drugs trying to jump on the COPD biotrend
Biological drugs are breaking into chronic obstructive pulmonary disease (COPD), two blockbuster antibodies have expanded FDA-approved uses of the lung disease over the past year. Roche Drugs just suffered setbacks to join them.
Roche’s astegolimab achieved the main goal of a key study, but failed to achieve that goal in another study, the pharmaceutical giant reported on Monday. The company said it will share more detailed results at an upcoming medical conference.
Roche uses astegolimab, which aims to treat inflammatory diseases by blocking IL-33, a signaling protein involved in inflammation and immune responses. The drug is a monoclonal antibody designed to bind to the ST2 receptor, thus blocking binding to IL-33. Roche has previously studied the drug in asthma, severe COVID-19 pneumonia and atopic dermatitis.
In COPD, Roche tested Astegolimab in a Phase 2 test, which enrolled patients with moderate to severe disease. The drug’s registration program covers two placebo-controlled key tests, both recruiting all debuggers, including current and former smokers. All researchers' studies are more representative of patients who may be taking medication in the real world.
In the Phase II and Phase III studies, subcutaneous injections were evaluated on top of CARE CARE COPD maintenance therapy every two weeks. The main goal of the study was to measure the annualized rate of intensification of moderate and severe COPD over 52 weeks. Roche said 2B tests in 1,301 patients showed that their drug reduced its annualized aggravation rate by 15.4% at 52 weeks, enough to be statistically significant. In 1,375 patients' Phase 3 test, 14.5% of the annualized aggravation was numerically better than placebo, but not statistically significant. Roche said the security of astegolimab is consistent with previous research and no new security signals have been identified.
“This is the first set of studies on the 'All-CopD population and we will discuss the data with regulators to evaluate the next step for astegolimab,” said Levi Garraway, Chief Medical Officer and Global Product Development at Roche, in a prepared statement.
Data readings for Astegolimab followed the mixed results of IL-33 blocking antibodies from Regeneron Pharmaceuticals. In May, Regeneron reported that the drug Itekimab met the main goal of a phase 3 study, with moderate or severe acute exacerbations reduced by 27% at week 52. However, the separate phase 3 test does not meet this goal. Regeneron is developing Itepekimab under a partnership with Sanofi. The two companies are already partners in the blockbuster drug dupixent, which blocks antibodies to the signaling proteins IL-4 and IL-13. IL-33 blocking drugs will provide them with an alternative to COPD.
With Astegolimab, Roche hopes to join the biopharmaceutical group of COPD driven by inflammation. Last year, Dupixent added COPD to its FDA-approved instructions list. In May, GSK's core expanded its tags to COPD. The GSK drug is an antibody designed to block IL-5.
Photo: Giuseppe Aresu/Bloomberg, by Getty Images
