Sanofi, Regeneron etch out another PhIII victory for Dupixent, easing severe itch and clearing lesions
Sanofi and Regeneron can boast of another inflammatory disease where Dupixent has proven effective.
The best-selling drug, which targets both IL-4 and IL-13, has delivered a clean sweep in a Phase III trial for prurigo nodularis, a chronic disease characterized by itch so intense that it can affect patients’ sleep and psychology. Thick skin lesions can cover most of the body.
On the primary endpoint, 37% of patients taking Dupixent saw a clinically meaningful reduction in itch compared to 22% of those on placebo (p=0.0216) at week 12. All secondary endpoints were also met, including clearance of skin lesions and improvement in quality of life.
Although the win came as little surprise to analysts, execs were sure to highlight its significance — not just in efficacy but also safety.
For the first time, according to Regeneron president and CSO George Yancopoulos, a systemic therapy was able to address debilitating symptoms without broadly suppressing the immune system.
“Prurigo nodularis is an underdiagnosed disease with immense physical and emotional burden for the 74,000 people in the U.S. who are unable to control their disease with topical steroids and otherwise do not have an approved treatment option,” he said in a statement. “These patients are left to cope with severe itching and painful nodules that, in turn, significantly impair one’s quality of life with many resorting to immunosuppressants and some to antidepressants.”
John Reed, Sanofi’s global head of R&D, added that the data will play a part in reshaping the understanding of type 2 inflammatory disease — an umbrella that also covers several of Dupixent’s approved indications, including atopic dermatitis and asthma.
“These data are an important step forward in furthering our knowledge of the role that targeting IL-4 and IL-13 can play in the treatment of skin diseases that cause extreme itch,” said Reed, noting that nearly all of the patients had severe itch going into the study and “40% had 100 or more nodules covering their body.”
The PRIME2 study enrolled a total of 160 patients, 78 of whom were randomized to the Dupixent arm.
At 24 weeks, 58% of the drug arm saw a clinically meaningful reduction in itch compared to 20% of placebo patients (p<0.0001); Dupixent patients were nearly three times as likely to achieve clear or almost clear skin (45% versus 16%, p<0.0001); and patients on treatment also experienced greater improvements in measures of health-related quality of life, skin pain and symptoms of anxiety and depression, although those numbers were not spelled out.
For analysts, the results add weight to the data wall Sanofi and Regeneron have been building around its megablockbuster, which brought in $2.76 billion in the first of the year.
“Management believes that there is considerable room for growth, and we agree that there is no near-term end to the product’s atopic march with positive Phase 3 results in CSU and additional readouts in prurigo nodularis (PN), eosinophilic esophagitis, and pediatric atopic dermatitis later this year,” Brian Skorney of Baird wrote in an August note. “While a number of competitive products are looking to piggyback on Dupi’s success, we don’t see any major risks to this franchise given how broadly safe and effective it has been shown to be.”