Sanofi, Regeneron Report Positive Phase 3 Results For Asthma Drug Dupixent's Use In Children

Sanofi SA SNY and Regeneron Pharmaceuticals Inc REGN disclosed that their asthma drug Dupixent (dupilumab) met its primary and all key secondary endpoints in randomized Phase 3 clinical trials demonstrating improved lung functions in children aged between six to 11 years.

Data from trial results hint that Dupixent holds a lot of promise for children (aged between six to 11 years) with uncontrolled moderate-to-severe asthma.

The drug is the outcome of a collaboration between Sanofi and Regeneron, using the latter's VelocImmune technology, which utilizes a proprietary genetically-engineered mouse platform endowed with a genetically-humanized immune system to produce optimized fully-human antibodies.

Trial Details: The clinical trial enrolled 408 children aged between six to 11 years with moderate-to-severe uncontrolled asthmatic conditions.

In a broad type 2 inflammatory asthma patient population, defined as having elevated eosinophils, data showed reduced exacerbations and enhanced lung functions in the first two weeks after administering the first dosage of the drug compared to standard of care alone.

Dupixent reduced rate of severe asthma attacks, with 65% and 59% average reduction over one year compared to placebo groups.

Improvement in lung function at 12 weeks compared to baseline of 10.15 and 10.53 percentage points for Dupixent versus 4.83 and 5.32 percentage points for placebo, respectively.

"Dupixent is the only biologic shown in a controlled Phase 3 trial to improve lung function in children, which is generally consistent with results seen in the adolescent and adult trials," Sanofi’s Global Head of Research and Development, John Reed said.

Why Does It Matter: The regulatory submissions for Dupixent in the U.S. and Europe would commence by the first quarter of 2021.

JPMorgan Chase & Co JPM analyst Richard Vosser maintains a buy rating on Sanofi and expects a $6.06 earnings per share in the fourth quarter of 2020.

Price Action: SNY closed 0.53% higher to $51.07 on Monday and REGN witnessed a marginal 0.09% drop to close at $601.54.

Photo courtesy: Sanofi and Regeneron Pharmaceuticals, Inc