A pair of phase 3 clinical trials of Arcutis Biotherapeutics’ roflumilast cream have met their primary endpoints, teeing the company up to seek FDA approval in plaque psoriasis in the second half of the year.
The drug candidate, ARQ-151, is a topical formulation of the PDE4 inhibitor found in AstraZeneca’s chronic obstructive pulmonary disease treatment Daliresp. Arcutis struck a deal to reformulate the active ingredient into a topical cream in the belief it could improve on the risk-benefit profile of other PDE4 skin disease treatments sold by Amgen and Pfizer.
The phase 3 trials advanced that strategy by showing ARQ-151 outperforms placebo in patients with mild, moderate or severe plaque psoriasis. Both studies met their primary endpoints, which assessed the effect of the cream on the Investigator Global Assessment (IGA) scale used to measure the severity of plaque psoriasis.
After eight weeks of treatment, the proportion of patients on ARQ-151 who had a clear or almost clear IGA score following a two-grade or greater improvement in the two trials was 42.4% and 37.5%. Fewer than 7% of subjects on placebo in both trials experienced such an improvement. Arcutis also tracked statistically significant improvements on key secondary endpoints that assessed symptom severity on different scales, the effect on itching and patient-reported outcomes.
While positive for Arcutis, the comparison between ARQ-151 and the vehicle control means little for the drug’s prospects of carving out a piece of the plaque psoriasis market. To win share, Arcutis will need to persuade patients and physicians that ARQ-151 offers benefits over incumbent products.
Arcutis began that process in its presentation to disclose the results. The presentation featured comparisons of the results generated by ARQ-151 and data on rival assets including Amgen’s Otezla and Dermavant’s near-approval tapinarof. Arcutis compared the magnitude and speed of the effects associated with ARQ-151 favorably to the results of other studies, although, as a post hoc assessment of data from different trials, that comparison may be unreliable.
In a competitive space, small differences could matter. Arcutis is emphasizing the effect of ARQ-151 on itch and its tolerability profile as potential differentiators. Incumbents and fellow challengers, such as Bristol Myers Squibb with its near-approval deucravacitinib, are also making their cases.
Arcutis, having seen its share price jump following the release of the data, raised money to support its push to make a success of ARQ-151, grossing more than $190 million in a public stock offering.