Make way, Dermavant. Two months after the company vowed to upend the plaque psoriasis market with its newly approved vanishing cream, there’s another topical to contend with.
Arcutis Biotherapeutics secured a win on Friday for its phosphodiesterase-4 (PDE4) inhibitor roflumilast, now marketed as Zoryve in plaque psoriasis for children and adults ages 12 and up.
You may recognize roflumilast as the active ingredient in AstraZeneca’s COPD drug Daliresp. PDE4s have long been used to treat skin and other inflammatory conditions, with Otezla being one of the most notable. However, earlier generations carry burdensome side effects, most commonly nausea, diarrhea and vomiting that “really limited the usefulness of PDE4s,” CEO Frank Watanabe said.
With a topical version, Arcutis says it’s able to shut down PDE4 locally, avoiding systemic exposure and side effects. The Westlake Village, CA-based biotech touts Zoryve as the first topical PDE4 inhibitor approved for plaque psoriasis.
“We see a tiny, tiny bit of diarrhea, and that’s about it. We don’t see any of the other issues,” Watanabe said.
The chief executive added that he doesn’t see Zoryve competing directly with Otezla and other ultra-effective biologics in the crowded plaque psoriasis market, which is dominated by drugs such as Stelara and Skyrizi. Rather, Arcutis is looking to replace high-potency topical steroids, which can’t be used for long periods of time or on sensitive parts of the body.
“What we’re trying to solve for is creating a product where the patient doesn’t have to make those trade-offs, right?” Watanabe said. “I get my efficacy and I get my safety and I can use it chronically and I can use it everywhere.”
Last February, Arcutis touted results from two pivotal trials in which roflumilast cream 0.3% had an IGA success rate (a visual assessment of improvement in plaque psoriasis trials) of 42.4% compared to 6.1% on vehicle, and 37.5% versus 6.9% (p<0.0001 for both trials). Those patients saw at least a 2-grade improvement from baseline, with their plaque psoriasis cleared or almost cleared.
Zoryve also hit every secondary endpoint, including Intertriginous IGA (I-IGA) Success, Psoriasis Area and 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 Symptom Diary (PSD).
Arcutis showcases positive PhIII data showing its topical cream scratched the sweet spot Otezla or steroids couldn’t
While Dermavant is also looking to replace topical steroids with Vtama, Watanabe noted some benefits of Zoryve, including price and the inclusion of kids 12 years and older. Vtama is currently approved only in adults, and its list price is over $1,300. According to the company’s website, patients with commercial insurance may be able to get the once-daily cream with no out-of-pocket cost, while those who are uninsured may pay as low as $75.
With topical approval, Dermavant looks to bring new standard-of-care to plaque psoriasis patients Arcutis plans to sell Zoryve at $825 per tube, though their patient assistance program will allow some patients who are uninsured or underinsured to get the product for free, Watanabe said.
Watanabe noted that the company has not conducted a head-to-head study pitting Zoryve against Dermavant’s Vtama.
Zoryve should be on shelves by mid-August, he said, adding that topicals are harder to launch than orals and injectables because the label must be printed on the tube before it’s filled.
“There might be a little bit longer lag, but our goal is to get it out as quickly as we can and we’re hoping in a few weeks post-approval to be able to have the drug in patients’ hands,” he said.
Next up, Arcutis is looking at Zoryve in atopic dermatitis. The company also has a foam version of the PDE4 inhibitor, which is similar in consistency to hair mousse, and is currently under study in seborrheic dermatitis and scalp and body psoriasis.
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Nicole DeFeudis
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