Blockbuster performance: Regeneron, Sanofi add stellar PhIII dupilumab data on display at EADV

After a steady drumbeat of praise from Regeneron and its partners at Sanofi, investigators today backed up their unblushing optimism over their late-stage drug prospect dupilumab with a batch of stellar late-stage trial data for atopic dermatitis, adding to the positive profile already sketched out.

The scientists turned up at the European Academy of Dermatology and Venereology in Vienna to review the data from SOLO1 and SOLO2. And it was worth the wait for a drug they plan to market as Dupixent as they look to start racking up revenue against the multibillion-dollar peak sales estimates that have hovered around this drug.

On every major score, dupilumab handily outperformed the placebo, underscoring the partners’ high expectations for a therapy that’s also in late-stage testing for asthma. And new data on itching and depression should help close the sale.

Gianluca Pirozzi

Gianluca Pirozzi

“I truly believe this is going to be revolutionary for many patients,” Gianluca Pirozzi, the global project head for Sanofi, tells me. This is the first monoclonal antibody that blocks both Il-4 and IL-13 cytokines, and there’s nothing that looks like a rival threat on the near horizon, leaving these two big players a lot of room to move.

The patients in these stories represent a severely afflicted group, he adds, with no chance of relief. And while a long way from a universal effect, the data indicate that this drug has a tremendous amount of commercial potential, with little in the way of safety issues to fret about.

The full report card now includes:

On the Pruritus NRS ranges from 0 (no itch) to 10 (worst itch imaginable). At 16 weeks, for SOLO 1 and SOLO 2, respectively, 41 and 36 percent of patients who received Dupixent 300 mg every two weeks, and 40 and 39 percent of patients who received Dupixent 300 mg weekly, achieved a four-point or greater reduction in their NRS score compared to 12 and 10 percent with placebo.

Lest anyone forget, the two big partners have also posted an impressive amount of positive data.

On the primary endpoint: 37 and 36 percent of adult patients who received Dupixent 300 mg weekly, and 38 and 36 percent of patients who received Dupixent 300 mg every two weeks, achieved clearing or near-clearing of skin lesions as measured by the 5-point Investigator’s Global Assessment (IGA) scale. In the placebo arm, those rates were tracked at 10 and 8 percent with placebo.

On another EU primary and US secondary endpoint: 52 and 48 percent of adult patients who received Dupixent 300 mg weekly, and 51 and 44 percent of patients who received Dupixent 300 mg every two weeks, achieved a 75 percent or greater reduction in their Eczema Area and Severity Index score (EASI-75). In the placebo arm that hit 15 and 12 percent.

On the percent improvement in EASI from baseline:  The score was 72 and 69 percent in patients who received the 300 mg weekly dose, and 72 and 67 percent for patients who received Dupixent 300 mg every two weeks, compared to 38 and 31 percent for placebo.

Based on the data they’ve seen so far, it looks like they will go with a drug dosed once every two weeks. Dupilumab was recently filed with the FDA and is getting a priority review, with a PDUFA date on March 29. So far, this drug has been sailing through a big Phase III without a hitch.

Analysts haven’t overlooked the potential here, but there has been some fretting that payers are already laying in wait for a big new therapy like this. And that could make it hard for these partners to realize the kind of big gains that have been forecast. Geoffrey Porges notes:

We now look to the partnered commercial organizations to explain how they plan to price and promote dupi, at a manageable expense investment, to avoid the formidable roadblocks that have stalled the recent launches of other chronic use specialty therapeutics with large commercial opportunities. Otherwise we have concerns that the stock is facing launch estimates that are too high, and launch revenue that falls short of potential.

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