Regeneron, Sanofi Stock Falls After Uneven Smoker's Lung Drug Data

Regeneron Pharmaceuticals, Inc. REGN and Sanofi SA SNY on Friday announced results from two Phase 3 trials of itepekimab in chronic obstructive pulmonary disease (COPD) patients.

Phase 3 AERIFY-1 trial evaluating 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.

A second Phase 3 trial, AERIFY-2, did not meet the same primary endpoint. Despite showing some benefit earlier in the trial (at week 24), itepekimab did not achieve a statistically significant reduction in moderate or severe exacerbations at week 52 in the second trial.

Also Read: GSK’s Once-Daily Inhalers For Smoker’s Lung Has Potential Benefits: Independent Organization Report

In the trials, patients were randomized to receive itepekimab every two weeks (AERIFY-1: n=375; AERIFY-2: n=326), every four weeks (AERIFY-1: n=377; AERIFY-2: n=303), or placebo (AERIFY-1: n=375; AERIFY-2: n=324), 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 total number of exacerbations was lower than prospectively anticipated, decreasing the power of both trials. Enrollment largely occurred during the global COVID-19 pandemic, which could have contributed to the lower overall exacerbation rates.

The safety profile of itepekimab was consistent across dosing regimens, and adverse events (AEs) were generally comparable between treatment and placebo groups.

Regeneron and Sanofi will review the data and discuss it with regulatory authorities to evaluate the next steps.

Itepekimab is also being evaluated in other respiratory conditions, including chronic rhinosinusitis without nasal polyps, chronic rhinosinusitis with nasal polyps, and non-cystic fibrosis bronchiectasis.

In November 2024, Regeneron and Sanofi’s Dupixent gained FDA approval for COPD, marking its sixth U.S. indication since its first use for atopic dermatitis seven years ago.

This expansion positions Dupixent as the first targeted therapy for COPD, a significant leap in treating this progressive lung condition that impedes breathing due to obstructed airflow.

Last Thursday, the U.S. Food and Drug Administration (FDA) approved GSK Plc’s GSK Nucala (mepolizumab) as an add-on maintenance treatment for adult patients with inadequately controlled COPD and an eosinophilic phenotype.

Last June, the FDA approved Verona Pharma plc's VRNA Ohtuvayre (ensifentrine) for the maintenance treatment of chronic obstructive pulmonary disease (COPD) in adult patients.

Ohtuvayre is the first inhaled product with a novel mechanism of action available for the maintenance treatment of COPD in more than 20 years.

In May, Sanofi announced it will invest at least $20 billion in the U.S. through 2030. Research and development, plus U.S. manufacturing, will receive the bulk of the spending.

The company also expects higher job creation within the communities where Sanofi and its partners are located, which will help enhance the U.S. supply chain.

Earlier in May, Regeneron secured the winning bid in the bankruptcy auction for key assets of 23andMe Holding Co. in a $256 million deal to boost its genetics-based drug discovery efforts.

Price Action: REGN stock is down 9.98% at $545, and SNY stock is down 4.57% at $49.96 during the premarket session at last check Friday.

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