Regeneron Pharmaceuticals (REGN) and Sanofi have announced new results from a Dupixent (dupilumab) Phase 3 open-label extension trial that showed the safety and efficacy profile observed in previous Dupixent trials was maintained for up to three years in adults and adolescents with moderate-to-severe asthma.
Data from the trial will be presented during a live session at the virtual 2020 European Respiratory Society (ERS) International Congress.
“These data suggest Dupixent may slow the progressive decline in lung function that many patients with moderate-to-severe asthma experience, as shown by the sustained improvement in lung function for up to three years. Further, patients on Dupixent maintained asthma control and reduced rates of severe asthma attacks that may result in hospitalizations,” cheered principal investigator Michael Wechsler.
“This reinforces the importance of Dupixent as a continuous, long-term treatment option to improve patients’ ability to breathe and maintain control of their asthma, particularly in those with higher markers of underlying type 2 inflammation” he added.
The analyses to be presented at ERS included more than 2,200 patients who previously participated in Dupixent asthma trials, including three pivotal trials that lasted between 24 and 52 weeks.
Results showed that patients continued to experience improvement in lung function by 13-22% at 96 weeks, as measured by the average change in forced expiratory volume over one second (FEV1) compared to baseline for the initial asthma trials.
Patients also maintained a low rate of severe asthma attacks with an average of 0.31-0.35 events per year vs 2.09-2.17 events per year pre Dupixent, a fully-human monoclonal antibody that inhibits the signaling of the interleukin-4 (IL-4) and interleukin-13 (IL-13) proteins.
Finally, patients showed reductions in blood eosinophils (23-35%) and in blood IgE for patients from the pivotal Phase 2b trial (82%) compared to baseline for the initial asthma trials.
In terms of safety the proportion of patients with adverse events (AEs) in the open label extension trial was similar to that seen in prior pivotal trials of Dupixent in asthma. Over the 96-week treatment period, overall AE rates were 76-88%, and the most common AEs were nasopharyngitis (18-26%) and injection-site erythema (2-23%). Overall serious AEs were experienced by 9-13% of patients.
In addition to the currently approved indications, Regeneron and Sanofi (SNYNF) are also studying dupilumab in a broad range of clinical development programs for diseases driven by allergic and other type 2 inflammation, including pediatric asthma and pediatric atopic dermatitis.
Shares in REGN have surged 55% year-to-date, and analysts have a cautiously optimistic Moderate Buy consensus on the stock’s outlook. That’s with an average analyst price target of $661, indicating 14% further upside potential lies ahead.
“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, 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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