Sanofi (SNYNF) and Regeneron have announced that a pivotal Phase 3 trial of Dupixent (dupilumab) met its primary and all key secondary endpoints in children aged 6 to 11 years with uncontrolled moderate-to-severe asthma.
In a broad type 2 inflammatory asthma patient population, Dupixent added to standard of care significantly reduced asthma attacks and improved lung function, as early as two weeks after the first dose, compared to standard of care alone.
Safety results from the clinical trial of 408 children were generally consistent with the known safety profile of Dupixent in patients aged 12 years and older with moderate-to-severe asthma. Over one year, overall rates of adverse events were 83% for Dupixent and 80% for placebo.
“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. These positive data are especially encouraging for younger children who are struggling to manage their uncontrolled asthma” commented John Reed, Global Head of Research and Development at Sanofi.
The primary endpoint assessed the annualized rate of severe asthma attacks. Those who added Dupixent (100 mg or 200 mg every two weeks, based on weight) to standard of care experienced a reduced rate of severe asthma attacks, with a 65% and 59% average reduction over one year compared to placebo.
They also reported improved lung function at 12 weeks compared to baseline by 10.15 and 10.53 percentage points for Dupixent vs. 4.83 and 5.32 percentage points for placebo.
Dupixent is a fully-human monoclonal antibody that inhibits the signaling of the interleukin-4 and interleukin-13 proteins. Data from Dupixent clinical trials have shown that IL-4 and IL-13 are key drivers of the type 2 inflammation that plays a major role in asthma, chronic rhinosinusitis, atopic dermatitis and eosinophilic esophagitis.
Turning to the Street, both Sanofi and Regeneron (REGN) score a cautiously optimistic Moderate Buy consensus. Meanwhile the average analyst price target indicates roughly 20% upside potential for Sanofi, and 11% for REGN. However Sanofi has only climbed 4% year-to-date, while Regeneron has exploded over 60%.
“REGN is on the cusp of: (1) strong 20/21 sales growth, (2) increased Eylea penetration in DME in 2020/21; (3) approval, launch, and fast uptake of Dupixent in asthma/other allergic conditions; and (4) approval, launch, and fast uptake of Libtayo in advanced cSCC/other oncology indications” commented Oppenheimer’s Hartaj Singh recently.
He has a buy rating on the stock and $725 price target, adding “we continue to believe investors should own the three leaders (respectively) in the COVID-19 race; GILD, REGN, and MRNA.” (See REGN stock analysis on TipRanks).
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