Westlake Village-based Arcutis Biotherapeutics has announced the enrollment of its first patient in a Phase 3 clinical trial of topical roflumilast cream, a treatment for scalp and body psoriasis which affects more than 8 million patients in the United States. Roflumilast foam is a once-daily formulation of roflumilast which the company is also developing for treatment of seborrheic dermatitis and scalp and body psoriasis. The new clinical trial, called Arrector, is one of two identical trials that is required by the Food and Drug Administration for eventual product approval. The company said in a statement that based on prior conversations with the FDA, it believes that if successful, the trial will provide sufficient basis to file a supplemental NDA for the study’s active ingredient, called ARQ-154.
The other trial, named Dermis, has completed all its phases for a similar roflumilast cream product ARQ-151 that the company will file an FDA submission for later this year. If FDA submissions go according to plan, the cream will be Arcutis’ first commercial product. The cream targets plaque psoriasis, a condition that appears as inflamed and scaly patches on skin.
“All of (the studies) have been very consistent in the results as we had hoped,” Frank Watanabe, chief executive of Arcutis, said about the Dermis trials. “What we have is a drug that is as effective as any other topical that has ever been developed for plaque psoriasis. But it has the added benefit of being extremely well tolerated and safe and can be used chronically.”
Watanabe expects to see similar results in the Arrector study, but the company will still need to develop additional data to prove that the drug is both safe and well tolerated when treating the scalp.
Watanabe said that the company did not experience much of an impact with the onset of the COVID-19 pandemic. Apart from the initial shutdowns that the virus caused, Arcutis’ clinical trials saw and continue to see minimal disruptions.
The progress on research comes as Arcutis continues to grow its employee base and prepares for a potential product launch sometime next year, when it will transition into a revenue-generating company.
Arcutis, now around five years old, has roughly tripled in size every year since it was founded, according to Watanabe. The company began with three employees, went public in February 2020 and now has around 130 employees. “We’re growing very rapidly, we expect to add something like 100 people in the next 12 to 18 months,” Watanabe said.
Watanabe lauded Arcutis’ investors and its board, who have experience in dermatology, law, finance, commercial operations and information technology.
“Frankly, one of the reasons that we’re in the San Fernando Valley is that there’s a wealth of talent in the area,” Watanabe said. “Whether its Amgen alumni, Kite alumni, Baxter alumni, there’s just a lot of very, very talented biotech people in the San Fernando Valley.”