Arcutis showcases positive PhIII data showing its topical cream scratched the sweet spot Otezla or steroids couldn't
The goal at Arcutis Biotherapeutics $ARQT had been clear and straightforward from day 1: to prove that it can take existing compounds against well established dermatology targets and make reformulations that hit a sweet spot not yet scratched by any of its myriad blockbuster, generic or experimental rivals.
The first proof came Monday in the form of positive topline results from a pair of pivotal Phase III trials. Investors reacted cheerfully, sending the stock up 28.14% to $34.97.
ARQ-151, a topical cream of PDE4 inhibitor roflumilast (you may recall it as the active ingredient in AstraZeneca’s COPD drug Daliresp), beat placebo in clearing plaque psoriasis, Arcutis reported.
Mark Lebwohl, the dean for clinical therapeutics at Icahn School of Medicine at Mount Sinai, was a participant in the trial. He highlighted a “profound impact on itch” and quick effect as a key part of the data.
“The impact of plaque psoriasis extends beyond the serious physical burdens of the disease, with many patients experiencing adverse psychological and social effects as well,” he noted in a statement. “The existing topical treatments prescribed to psoriasis patients have significant shortcomings, which lead to difficult trade-offs between efficacy, safety, and tolerability.”
Looking at the primary endpoint, as assessed by the investigator, roflumilast cream 0.3% had an IGA success rate of 42.4% compared to 6.1% on vehicle in DERMIS-1; in DERMIS-2, the difference was 37.5% versus 6.9% (p<0.0001 for both trials). These patients had their plaque psoriasis cleared or almost cleared and saw at least a 2-grade improvement from baseline.
The cream also hit all the secondary endpoints, including Intertriginous IGA (I-IGA) Success, Psoriasis Area Severity Index-75 (PASI-75), reductions in itch as measured by the Worst Itch-Numerical Rating Scale and patient perceptions of symptoms as measured by the Psoriasis Symptoms Diary (PSD).
Among those who were given roflumilast cream, 90% completed the full 8-week treatment — with only 5 discontinuations in DERMIS-1 and 1 discontinuation in DERMIS-2 due to side effects. None were severe.
But the real test ARQ-151 is facing won’t be limited to placebo, and Arcutis knows it. In an investor presentation, the Frazier-backed company contextualized its data by comparing them directly against commonly prescribed drugs.
“These data reinforce our conviction that topical roflumilast is exceptionally well suited to address the unmet needs in the topical treatment of psoriasis, offering an ideal combination of efficacy comparable to the results of published clinical studies of high-potency steroid/calcipotriene or high-potency steroid/tazarotene combination products, the ability to use the drug chronically in any anatomical area, and a very favorable safety and tolerability profile,” CMO Patrick Burnett said.
He expects filing an NDA in the second half of 2021, setting up the first in an anticipated series of wide-ranging approvals in big-market indications CEO Frank Watanabe has mapped out.
Social: Frank Watanabe, Arcutis CEO