- Study met its main endpoint with 80% of people handled with roflumilast foam attaining Investigator Global Assessment (IGA) Success in comparison with 59% of sufferers handled with automobile (P<0.0001)
- More than 60% of sufferers handled with roflumilast foam achieved an itch response at Week 8, with vital enhancements on the 2-and 4-week assessments
- Statistically vital enhancements in comparison with automobile on all secondary endpoints together with scaling and erythema (redness)
- Roflumilast foam was well-tolerated with no proof of native irritation
- New drug software (NDA) submission anticipated in 1Q of 2023
WESTLAKE VILLAGE, Calif. and MILAN, Italy, Sept. 09, 2022 (GLOBE NEWSWIRE) — Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), an early-stage business firm centered on growing significant improvements in immuno-dermatology, in the present day introduced new knowledge from the STRATUM pivotal Phase 3 trial investigating roflumilast foam as a possible remedy for kids ages 9 and above and adults with reasonable to extreme seborrheic dermatitis had been introduced orally on the Academy of Dermatology and Venereology (EADV) Congress. Roflumilast foam 0.3% is an investigational once-daily topical foam formulation of a extremely potent and selective phosphodiesterase kind 4 (PDE4) inhibitor being developed to deal with inflammatory dermatoses, significantly in hair-bearing areas of the physique such because the scalp.
The research met the first endpoint with 80.1% of people handled with roflumilast foam attaining ‘IGA Success’ in comparison with 59.2% of sufferers handled with automobile (P<0.0001) at week eight. IGA Success was outlined as an IGA rating of clear or virtually clear plus a ≥2 grade enchancment from baseline. Improvement with roflumilast foam was seen early, with roflumilast separating statistically from automobile on IGA Success at week two, the primary timepoint assessed.
“Topical therapies are the standard of care for the treatment of seborrheic dermatitis, but today’s options come with limitations, including side effects and the inability to use on both hair- and non-hair- bearing areas of the body,” stated Dr. Andrew Blauvelt, M.D., M.B.A., lead research writer and president of Oregon Medical Research Center. “Roflumilast foam demonstrated strong efficacy across multiple endpoints, including 50% of individuals with seborrheic dermatitis achieving IGA clear at week 8. Local tolerability was also highly favorable as reported by both patient and investigator assessments of irritation, burning, and stinging.”
Roflumilast foam additionally demonstrated statistically vital enhancements in comparison with automobile on all secondary endpoints within the trial, together with itch, scaling, and erythema (redness).
- More than 60% of people with a Worst Itch-Numerical Rating Score (WI-NRS) of 4 or increased at baseline handled with roflumilast foam achieved a ≥4-point discount in itch at Week 8. (63.6% with roflumilast foam vs 42.3% automobile (P=0.0002))
- More than 50% of people handled with roflumilast foam achieved an erythema rating of 0 at week 8. (57.9% with roflumilast foam vs 32.7% automobile (P<0.0001))
- More than 50% of people handled with roflumilast foam achieved a scaling rating of 0 at week 8. (58.2% with roflumilast foam vs 37.5% automobile (P=0.0001))
Roflumilast foam was well-tolerated. The incidence of Treatment Emergent Adverse Events (TEAEs) was low and related between lively remedy and automobile, with most TEAEs assessed as gentle to reasonable severity. There had been no treatment-related Serious Adverse Events (SAEs). Overall, the commonest opposed occasions within the research inhabitants (over 1%) included COVID-19, urinary tract an infection, nasopharyngitis, and nausea. Over 90% of sufferers who had been randomized to roflumilast foam within the research accomplished the complete eight weeks, and there have been few discontinuations as a consequence of opposed occasions (0.7% and a pair of.0% within the roflumilast foam and automobile teams, respectively). Roflumilast foam demonstrated favorable native tolerability with no proof of irritation in >98% of sufferers as assessed by the investigator and no or gentle sensations in reported by >92% throughout all timepoints and remedy teams.
“We are excited to share these additional data from our STRATUM phase 3 trial which show the potential for roflumilast foam to treat multiple signs and symptoms of seborrheic dermatitis, including itch, redness, and scaling,” stated Patrick Burnett MD, PhD, FAAD, Chief Medical Officer at Arcutis. “Roflumilast foam continues to demonstrate strong efficacy with a safety and tolerability profile that, if approved, should provide an important new non-steroidal treatment option for chronic use anywhere on the body, including the scalp.”
Arcutis plans to submit an NDA for roflumilast foam for the remedy of seborrheic dermatitis to the U.S. Food and Drug Administration (FDA) within the first quarter of 2023.
About STRATUM
The STudy of Roflumilast foam Applied Topically for the crimsonUction of seborrheic derMatitis (STRATUM) is a Phase 3, parallel group, double blind, vehicle-controlled research of the protection and efficacy of roflumilast foam 0.3% administered once-daily. A complete of 457 topics ages 9 years and older with reasonable to extreme seborrheic dermatitis had been enrolled within the research and had been randomized 2:1 roflumilast foam to automobile. The main endpoint of the research was the proportion of topics attaining IGA Success, outlined as an IGA rating of clear or virtually clear plus a ≥2 grade enchancment at week 8.
About Seborrheic Dermatitis
Seborrheic dermatitis impacts greater than 10 million folks within the U.S., and is a typical, power, or recurrent inflammatory pores and skin illness that causes crimson patches lined with massive, greasy, flaking yellow-gray scales, and protracted itch. Seborrheic dermatitis happens most frequently in areas of the physique with oil-producing (sebaceous) glands, together with the scalp, face (particularly on the nostril, eyebrows, ears, and eyelids), higher chest, and again.
About Topical Roflumilast
Arcutis is growing topical cream and foam formulations of roflumilast – a extremely potent and selective PDE4 inhibitor being investigated as a once-daily, nonsteroidal, topical remedy for a number of dermatologic circumstances. PDE4 – a longtime goal in dermatology – is an intracellular enzyme that will increase the manufacturing of pro-inflammatory mediators and reduces manufacturing of anti-inflammatory mediators. Roflumilast cream 0.3% (ZORYVE™) is permitted by the FDA for the topical remedy of plaque psoriasis, together with intertriginous areas, in sufferers 12 years of age and older. Roflumilast foam is a once-daily topical foam formulation of roflumilast which the Company is growing for each seborrheic dermatitis and scalp and physique psoriasis.
About ZORYVE
ZORYVE (roflumilast) cream 0.3% is indicated for topical remedy of plaque psoriasis, together with intertriginous areas, in sufferers 12 years of age and older.
IMPORTANT SAFETY INFORMATION
The use of ZORYVE is contraindicated in sufferers with reasonable to extreme liver impairment (Child-Pugh B or C).
The commonest opposed reactions (≥1%) embody diarrhea (3%), headache (2%), insomnia (1%), nausea (1%), software web site ache (1%), higher respiratory tract an infection (1%), and urinary tract an infection (1%).
Please see full Prescribing Information.
About Arcutis
Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT) is a medical dermatology firm that champions significant innovation to handle the pressing wants of people dwelling with immune-mediated dermatological ailments and circumstances. With a dedication to fixing essentially the most persistent affected person challenges in dermatology, Arcutis harnesses our distinctive dermatology improvement platform coupled with our dermatology experience to construct differentiated therapies in opposition to biologically validated targets. Arcutis’ dermatology improvement platform features a sturdy pipeline with a number of medical packages for a variety of inflammatory dermatological circumstances together with scalp psoriasis, atopic dermatitis, and seborrheic dermatitis. For extra info, go to www.arcutis.com or observe Arcutis on LinkedIn, Facebook, and Twitter.
Forward-Looking Statements
This press launch accommodates “forward-looking” statements, together with, amongst others, statements concerning the potential for roflumilast foam to be permitted for the remedy of adults and adolescents with seborrheic dermatitis, the potential to make use of roflumilast foam over an extended interval of time, or chronically, the potential to make use of roflumilast foam wherever on the physique, together with the face and scalp, anticipated submission of the NDA and the potential for roflumilast to advance the usual of care in seborrheic dermatitis and different inflammatory dermatological circumstances. These statements contain substantial recognized and unknown dangers, uncertainties and different components which will trigger our precise outcomes, ranges of exercise, efficiency, or achievements to be materially completely different from the knowledge expressed or implied by these forward-looking statements and you shouldn’t place undue reliance on our forward-looking statements. Risks and uncertainties which will trigger our precise outcomes to vary embody dangers inherent within the medical improvement course of and regulatory approval course of, the timing of regulatory filings, and our capacity to defend our mental property. For an extra description of the dangers and uncertainties relevant to our business, see the “Risk Factors” part of our Form 10-Ok filed with U.S. Securities and Exchange Commission (SEC) on February 22, 2022, as amended on March 3, 2022, in addition to any subsequent filings with the SEC. We undertake no obligation to revise or replace info herein to replicate occasions or circumstances sooner or later, even when new info turns into out there.
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