Sanofi SNY and partner Regeneron Pharmaceuticals, Inc, REGN announced that a phase II study evaluating their investigational IL-33 antibody REGN3500 (SAR440340) in asthma met the primary endpoint.
Top-line data from the phase II proof-of-concept study on the candidate showed that REGN3500 (SAR440340) monotherapy significantly reduced loss of asthma control (primary endpoint) and improved lung function (secondary endpoint) compared to placebo.
The study had four treatment groups namely REGN3500 plus placebo, REGN3500 plus Dupixent, Dupixent plus placebo, and placebo. Dupixent is Sanofi/Regeneron’s successful new drug, which is marketed for atopic dermatitis as well as moderate-to-severe asthma.
Coming back to the phase II REGN3500 study, patients in the Dupixent monotherapy group did numerically better than REGN3500 across all endpoints. Interestingly, the REGN3500 plus Dupixent group failed to demonstrate increased benefit compared to Dupixent monotherapy. The percentage of adverse events was 61.6% in the REGN3500 patient group, 66.2% in the REGN3500 and Dupixent group, 56.8% in Dupixent and 64.9% in the placebo patient group.
Sanofi and Regeneron are developing REGN3500 in phase II studies for atopic dermatitis, asthma and chronic obstructive pulmonary disease (COPD).
Sanofi’s stock has risen 1.2% this year so far, underperforming the industry's rise of 4.2%.
Asthma was the second indication for which Dupixent was approved in the United States in October 2018. The asthma indication has been boosting sales of Dupixent since then. Dupixent was approved for the asthma indication in EU in May 2019.
Dupixent is also being evaluated in phase III studies for other inflammatory disease like eosinophilic esophagitis and COPD and in phase II study for food and environmental allergies. It is under regulatory review for chronic rhinosinusitis with nasal polyps for which the FDA’s decision is expected next week. We are optimistic about sales prospects of Dupixent, which could prove to be an important growth driver for the company.
Sanofi currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Some better-ranked large-cap pharma stocks are AbbVie, Inc. ABBV and Merck & Co., Inc. MRK, both with a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Shares of Merck have gained 10.7% so far this year while estimates for 2019 and 2020 have risen 1.7% and 0.4%, respectively, over the past 60 days.
AbbVie’s earnings estimates have increased 1.5% for 2019 and 1.4% for 2020 over the past 60 days.
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