Phase 3 wins put Dermavant closer to filing Otezla rival tapinarof

Just two years after buying rights to psoriasis candidate tapinarof from GlaxoSmithKline, Swiss biotech Dermavant says it could be a few months away from filing for approval of the drug.

The Roivant group company has data in from two phase 3 trials – PSOARING 1 and PSOARING 2 – and reports that its cream formulation of tapinarof was able to increase the proportion of patients whose lesions cleared up compared to placebo.

Now, Dermavant is only waiting for results of a long-term safety trial called PSOARING 3 before it moves ahead with a marketing application to the FDA. That study is due to read out in November, so a filing could take place early next year if the data are positive.

Tapinarof is billed as a first-in-class, once-daily topical therapeutic aryl hydrocarbon receptor modulating agent (TAMA), and was GSK’s lead drug in immuno-inflammation R&D back in 2018 before it was licensed by Dermavant in a $250 million ($330 million) deal. It’s also in clinical testing for atopic dermatitis or eczema.

The drug – formerly known as GSK2894512 – could provide an alternative to topical steroid drugs, in common treatments for psoriasis which can have side effects such as skin thinning when used over an extended period.

For that reason, topical steroids aren’t recommended for sensitive areas like the face or areas where skin folds, like the armpit, groin or under the breasts. Tapinarof could provide a way to treat these areas more safely, according to Dermavant.

PSOARING 1 and 2 enrolled 1,025 patients with plaque psoriasis across a range of severities who were treated with either a 1% tapinarof cream or a placebo for 12 weeks.

At the end of that period,  35.4% and 40.2% of patients treated with tapinarof in the two trials, respectively, had either clear or almost clear skin, compared to 6% of subjects treated with the control cream.

A secondary measure – a 75% improvement on the Psoriasis Area and Severity Index (PASI) scale – occurred in 36.1% of the tapinarof group in PSOARING 1 and 47.6% in PSOARING 2, versus 10.2% and 6.9% of the respective control arms.

“Tapinarof cream could become a highly beneficial treatment option for adult patients living with mild, moderate and severe plaque psoriasis [including] sensitive and difficult-to-treat areas of the body,” said the biotech’s chief medical officer Philip Brown.

More severe cases of psoriasis can require the use of oral steroids, which can have other side effects such as weight gain, sleep disturbances and mood changes, As tapinarof has minimal systemic absorption it could also provide a safer alternative for these patients, according to Dermavant.

There’s a question mark over the size of the market opportunity for tapinarof even if it gets approved however, as the psoriasis market is evolving fast.

New antibody therapies such as Novartis’ Cosentyx (secukinumab) and AbbVie’s Skyrizi (risankizumab) are gaining traction at the severe end of the disease spectrum, for example, although that’s not a primary area of focus for Dermavant.

The company’s main rival at the moment is Amgen, which is confident it can grow its oral PDE4 inhibitor Otezla (apremilast) – acquired for an eye-watering $13.4 billion last year and currently approved for moderate-to-severe psoriasis – into milder forms of the disease.

Image by Anastasia Gepp from Pixabay

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