Incyte Meets Midphase Skin Condition Trial Goal

In its pursuit of Regeneron and Sanofi’s Dupixent in the treatment of prurigo nodularis, Incyte has set its own standard by establishing a relationship between its oral challenger and significant reductions in skin itching and the severity of the condition in a phase 2 research.

An experiment was conducted in which 146 individuals who were diagnosed with prurigo nodularis were randomly assigned to receive either a placebo or one of three daily oral dosages of the JAK1 inhibitor povorcitinib. Subjects who participated in the experiment, which started before the approval of Dupixent, had either not responded adequately to previous treatment or had the inability to tolerate it.

At the yearly conference of the American Academy of Dermatology, Incyte disclosed the main endpoint hit that occurred the previous year.

The percentage of patients who saw at least a four-point betterment on an itch scale after 16 weeks ranged from 36.1% to 54.1% for those using povorcitinib, as contrast to 8.1% of their counterparts who were taking a placebo. In the research, it was shown that the response rate increased in a dose-dependent manner, with the highest dose, 75 mg, doing the best in terms of both the time to reaction and the response rate.

For patients who were taking the high dose, a median of 17 days were needed to observe a four-point improvement, but for people who were taking the low dose, it took 58 days.

The third phase of the experiment that Regeneron and Sanofi were working on monitored the impact that Dupixent had on the itch scale. At the end of the first 24 weeks of treatment with Dupixent, 60% of patients in the PRIME trial and 57% in the PRIME2 trial experienced a four-point or higher improvement. The response rates for the placebo were 18.4% and 19.5%, respectively.

Researchers in each trial also assessed how many patients reported a reduction in itching and how many received a perfect score on the Investigator’s Global Assessment of Treatment Success. In the placebo group, just 2.5% of patients reached both criteria at week 16, compared to 35.1% of povorcitinib patients. The results for Dupixent amounted to 38.7% and 32.1% after 24 weeks, while the placebo group had 9.2% and 8.5%.

Povorcitinib may provide competitive effectiveness, with the usual disclaimer that comparing findings from different trials can be misleading – this is especially true when comparing data from different phases. Dupixent gained FDA clearance in 2022, but Incyte still thinks it’s better to follow rather than lead.

Steven Stein, M.D., Incyte’s chief medical officer, stated, “[Dupixent] has provided us the regulatory pathway on the way to go in terms of itch resolution and skin change resolution. We’ll offer the once-daily oral convenience. We think we’ll have a really good agent in terms of high efficacy.”