Arcutis' formulation of old AstraZeneca drug clears another PhIII test
Weeks after rolling out its first psoriasis treatment, Arcutis Biotherapeutics is racking up more positive Phase III data for a second formulation of an old AstraZeneca drug.
The Phase III ARRECTOR trial tested roflumilast foam in patients with scalp and body psoriasis, Arcutis said, and met both co-primary endpoints as well as all secondary endpoints. Nearly identical to its approved drug, Zoryve, which is a cream, the foam is water-based and moisturizing — properties that the biotech hoped could “overcome the challenges of delivering topical drugs in hair-bearing areas of the body.” Arcutis has previously compared it to hair mousse.
The new data burnish Arcutis’ promise of developing easy-to-use formulations of existing drugs for conditions of the skin.
According to the company, plaque psoriasis impacts nine million people in the US, 40% of whom have psoriasis that affects the scalp.
“Topical therapies are first-line treatments for scalp and body psoriasis, but current options have limitations including aesthetic acceptability, tolerability, effectiveness, and limited duration of use, which can lead to poor outcomes and significantly impact patients’ quality of life,” said Melinda Gooderham, study author and an investigator with Probity Medical Research.
In the trial, 67.3% of patients treated with the drug achieved Scalp-Investigator Global Assessment (S-IGA) success at week eight, compared to 28.1% of individuals treated with a matching vehicle foam (p<0.0001). At the same time point, 46.5% in the roflumilast foam group saw Body-Investigator Global Assessment (B-IGA) success, versus 20.8% in the comparator arm (p<0.0001).
The drug also spurred improvements in secondary endpoints such as scalp itch and overall itch.
A PDE4 inhibitor, roflumilast is the active ingredient in AstraZeneca’s COPD drug Daliresp. It belongs to the same class as Otezla, which has long been used to treat skin and other inflammatory conditions.
Arcutis paid AstraZeneca $1 million in cash, plus a number of its own shares, to develop the compound for dermatological uses.
The biotech added that the most commonly experienced adverse events among patients were headache, diarrhea and Covid-19. 2.5% of participants in the roflumilast foam group discontinued treatment due to these events. In the vehicle group, the discontinuation rate was 1.3%.
The results follow a positive readout for roflumilast foam in seborrheic dermatitis, for which Arcutis is planning an NDA filing early next year — with a sNDA in scalp and body psoriasis to follow.