- 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.
© 2024 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.
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