▎WuXi AppTec Content Team Editor
Arcutis Biotherapeutics announced today that its topical, highly potent and selective PDE4 inhibitor roflumilast foam 0.3% has been obtained in ARRECTOR Pivotal, a Phase 3 clinical trial for the treatment of scalp and body psoriasis. positive results. Study results showed that once-daily roflumilast foam 0.3% demonstrated favorable safety and tolerability and met the co-primary and all secondary endpoints of the Scalp and Body study.
Psoriasis is a common immune-mediated skin disease that affects approximately 90% of patients with plaque psoriasis, which is characterized by raised, red, and overlying skin Silver or white scales. Psoriatic plaques can appear anywhere on the body, but most often appear on the scalp, knees, elbows, trunk, and extremities, and are often itchy and sometimes painful. Topical topical therapy is the treatment of choice for most patients, however, current topical therapies (eg, corticosteroids) still suffer from various drawbacks in terms of efficacy and side effects.
PDE4 is an intracellular protease that increases the production of pro-inflammatory mediators and reduces the production of anti-inflammatory mediators and is associated with a wide range of inflammatory diseases. PDE4 inhibitors have been approved by the FDA for topical treatment of atopic dermatitis or systemic treatment of plaque psoriasis. Roflumilast has been approved by the FDA as an oral therapy to reduce the risk of chronic obstructive pulmonary disease (COPD) exacerbations. It showed greater potency (25-300 times) than the other two FDA-approved PDE4 inhibitors. In July this year, the US FDA approved the emulsion formulation of roflumilast
Zoryve goes public
, for the treatment of plaque psoriasis in patients over 12 years of age. According to the press release, Zoryve is the first topical PDE4 inhibitor approved for the treatment of plaque psoriasis. Roflumilast topical foam formulation is being developed to treat seborrheic dermatitis and scalp and body psoriasis.
▲Roflumilast’s R&D pipeline (Image source: Arcutis official website)
Scalp-Investigator Global Assessment (S-IGA) success rate was 67.3% in patients treated with roflumilast foam at Week 8 in this clinical study strong>, this value in the vehicle control group was 28.1% (P
46.5% compared to 20.8% in the vehicle control group (P
Arcutis Chief Medical Officer Dr. Patrick Burnett said: “We are delighted to share the latest results for the roflumilast foam formulation, a once-daily non-steroidal treatment option designed to Overcome the limitations of traditional creams and ointments in the hair growth area of the body. These pivotal Phase 3 study results demonstrate the robust efficacy and tolerability of roflumilast foam in the treatment of scalp and body psoriasis.”
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