Long Beach-based Dermavant Sciences Inc. announced Aug. 10 that its skin disease treatment drug candidate Tapinarof has been accepted by the FDA for the formal “new drug application” process. Tapinarof is designed as a once-daily, steroid-free topical cream for the treatment of plaque psoriasis and atopic dermatitis, also known as chronic skin inflammation.
Dermavant filed for a new drug application in May. In accepting the application, the FDA gave a target action date of second quarter 2022, or about nine months from now, according to the announcement from Dermavant.
“With the FDA acceptance of our new drug application for filing, Dermavant is one step closer to potentially providing a new option for adults with mild, moderate and severe plaque psoriasis, who often deal with itch, pain, disfiguring appearance, and significant emotional and physical distress,” Todd Zavodnick, Dermavant’s chief executive, said in the announcement.
Now for the company with the bad news.
On Sept. 2, Torrance-based Forte Biosciences Inc. announced that its main drug candidate to treat atopic dermatitis, a drug with the working name of FB-401, failed to show significant improvement over a placebo in a Phase 2 clinical trial. According to data presented in the announcement, the placebo slightly outperformed FB 401 in achieving the desired endpoint condition for treatment.
“Given this readout we will not continue to advance FB-401,” Paul Wagner, Forte Biosciences’ chief executive, said in a statement. “We expect to provide investors with an update on the future plans for the company over the next several months.”
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