Sanofi, Regeneron surge as Dupixent scores in COPD trial

2023-03-23

临床3期临床结果上市批准

Dive Brief:

An anti-inflammatory drug from Sanofi and Regeneron succeeded in a Phase 3 clinical trial in chronic obstructive pulmonary disease, giving the medicine, Dupixent, a chance to become the first biologic treatment approved for the condition.

Patients who received Dupixent on top of standard therapy experienced a 30% reduction, compared to a placebo and those same drugs, in the flare-ups, or “exacerbations,” that make their symptoms worse. Dupixent recipients also had a statistically significant improvement in lung function, quality of life and other disease markers, the companies said Thursday.

The results surpassed expectations of some Wall Street analysts and position the companies to seek approval if a second ongoing study produces positive results next year. However, Regeneron said in its statement that it will discuss the existing data with regulators. “We are unable to speculate on the outcome of those talks,” a spokesperson said in an email to BioPharma Dive.

Dive Insight:

Dupixent is already one of the industry’s top-selling drugs and has become a key source of revenue for both Sanofi and Regeneron, which developed the antibody together.

Since first reaching the U.S. market in 2017 as an eczema treatment, Dupixent has won approval for four other diseases. Global sales reached more than $9 billion last year, and Sanofi has projected that number could climb to over $13 billion as its use is expanded further.

An approval in COPD, one of the leading causes of death globally, could help. Analysts with RBC Capital Markets previously estimated an additional $3.4 billion in yearly sales if Dupixent succeeded in testing.

The study was viewed by analysts as a tough challenge for Dupixent, as COPD has historically been difficult to treat with biologic medicines. In the past few years, a top drug from AstraZeneca AstraZeneca failed in large trials, while the Food and Drug Administration rejected another from GSK.

Regeneron executives were still confident, though, because the company tested Dupixent in a subset of COPD patients with Type 2 inflammation, a type of immune response the drug disrupts. About one quarter of patients with moderate-to-severe COPD, or about 2.3 million people in the U.S., have this type of COPD, according to RBC analysts.

Thursday’s results “validate the role Type 2 inflammation plays” in driving COPD, Regeneron Chief Scientific Officer George Yancopoulos said in the companies’ statement.

Their study, called BOREAS, enrolled nearly 1,000 people with moderate or severe COPD who were current or former smokers and between 40 years to 80 years old. They received either Dupixent or a placebo every two weeks as an add-on therapy to standard, inhaled treatments.

The 30% reduction in symptom flare-ups the partners reported beat expectations of about 15% to 25%, according to Jefferies analyst Peter Welford. They also exceeded the 25% reduction that experts polled by RBC considered the minimum bar for a “clinically meaningful” result.

Dupixent’s side effect profile was “consistent” with previous tests, the companies said. Overall adverse event rates were similar between Dupixent- and placebo-treated participants.

Detailed findings will be presented at a future medical meeting.

In the meantime, the results will likely boost expectations for Sanofi and Regeneron’s other trial, which analysts at Baird see as necessary to support regulatory approval. “We expect similar results,” wrote analyst Brian Skorney in a client note. “While Dupixent has proven to be a titan in the Type 2 disease space, this is a derisking event.”

Regeneron shares surged 7% to record highs above $800 apiece in early morning trading Thursday. Sanofi shares spiked by nearly 6%.

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