Sanofi-Regeneron Highlight Dupixent Data, Say Drug Benefit Was Swift, Sustained

Regeneron Pharmaceuticals Inc REGN and Sanofi SA SNY presented results from a Phase 3 study of Dupixent (dupilumab) in adults currently on maximal standard-of-care inhaled therapy (triple therapy) with uncontrolled chronic obstructive pulmonary disease (COPD) and evidence of type 2 inflammation.
Dupixent demonstrated a significant reduction in moderate or severe acute exacerbations by 30% compared to placebo, meeting the primary endpoint.
Dupixent significantly improved lung function at 12 and 52 weeks, with numerical improvements seen as early as two weeks.
It significantly improved quality of life, with numerical improvements as early as four weeks after initiating treatment and respiratory symptoms.
In a pre-specified analysis from a subgroup of patients with elevated levels (≥20 ppb) of fractional exhaled nitric oxide (FeNO) – an airway biomarker of type 2 inflammation – Dupixent treatment also led to a significant 38% reduction in exacerbations compared to placebo at 52 weeks.
In this subgroup, Dupixent also led to an improvement in lung function of 232 mL versus 108 mL for placebo at 12 weeks (p=0.002) sustained at 52 weeks with an improvement in lung function of 247 mL versus 120 mL for placebo (p=0.003).
The second replicate Phase 3 trial of Dupixent in COPD with evidence of type 2 inflammation (NOTUS) is ongoing, with data expected in 2024.
Price Action: SNY shares are down 1.75% at $54.06, and REGN shares are down 2.03% at $743.58 on the last check Monday.