Regeneron and Sanofi’s Dupixent Shows ‘Positive’ Trial Data, Meets Co-Primary Endpoints


Drug companies Regeneron Pharmaceuticals, Inc (REGN) and Sanofi announced that results for their Dupixent drug used for the treatment of patients with swallowing difficulties showed clinical and anatomic improvements.

The two companies said that Dupixent Phase 3 trial data disclosed “positive results” in patients 12 years and older suffering from eosinophilic esophagitis (EoE). The trial met both of its co-primary endpoints, as well as all key secondary endpoints.

EoE is a chronic and progressive inflammatory disease which leads to swallowing difficulties and if untreated can lead to functional damage and scarring of the esophagus. In the U.S., there are about 160,000 patients with EoE of which about 50,000 have failed multiple treatments. There are currently no therapies approved by the U.S. Food and Drug Administration (FDA).

Dupixent is the first and only biologic to show positive and clinically-meaningful results in this population as part of a Phase 3 trial, the two companies said.

“For the first time in a Phase 3 trial, patients reported an improvement in their ability to swallow food,” said John Reed, Global Head of Research and Development at Sanofi. “For patients with eosinophilic esophagitis who are living with restricted diets and, in some cases, repeated hospital interventions, these findings are encouraging.”

Patients treated with Dupixent demonstrated 69% reduction in disease symptoms compared to 32% for placebo. The trial is ongoing, with additional patients enrolling in Part B as well as patients continuing in a 28-week extended active treatment period (Part C). Dupixent received Orphan Drug Designation from the FDA in 2017 for the potential treatment of EoE.

Shares in biotech colossus Regeneron have surged 53% year-to-date as some investors grow more confident in its drug pipeline including its experimental antibody cocktail for COVID-19.

Five-star analyst Hartaj Singh at Oppenheimer this month raised his price target on the stock to $625 from $525 and maintained a Buy rating.

“REGN now clearly can make a case for the best-in-class pipeline among its peers,” Singh said in a note to investors. “Given blockbusters already commercialized in Eylea & Dupixent and as an emerging oncology powerhouse, we believe that investors are not giving REGN’s pipeline enough value.”

What does the rest of the Street have to say? The 18 analysts are divided between 9 Buy ratings and 9 Hold ratings adding up to a Moderate Buy consensus. In view of the stock’s recent rally, the analysts’ $555.24 average price target is less optimistic than Singh’s indicating 2.6% downside potential in the coming 12 months. (See Regeneron stock analysis on TipRanks).

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