With new PhIII data in hand, Dermavant lines up topical psoriasis contender for a sprint to the finish line
In the next couple months, Dermavant CEO Todd Zavodnick says he’ll sprint to the FDA with tapinarof, the company’s “cosmetically elegant” vanishing cream to treat psoriasis. But before that, he has more Phase III data to share.
Around 20% of moderate to severe plaque psoriasis patients given tapinarof in two Phase III trials achieved 90% disease clearance, measured by the Psoriasis Area and Severity Index (PASI 90) at Week 12, Zavodnick shared Friday at the American Academy of Dermatology virtual meeting. And around 67% and 60% of patients in the trials felt itch relief starting as early as Week 2.
“We don’t talk PASI 90s with topicals,” Zavodnick told Endpoints News. “We talk PASI 90s with an oral or an injectable.”
The new data come from two Phase III trials dubbed PSOARING 1 and 2, which enrolled 510 and 515 adults with mild to severe plaque psoriasis, respectively.
According to Dermavant, 18.8% of patients given tapinarof achieved a 90% or greater reduction in PASI 90 at Week 12 compared to just 1.6% of patients given placebo in PSOARING 1, with a p-value of 0.0005. In PSOARING 2, 20.9% of patients on tapinarof achieved PASI 90, versus 2.5% in the placebo arm, with a p-value less than 0.0001.
Itch reduction was measured on the Peak Pruritis Numerical Rating Scale (PP-NRS). And according to patient-reported outcomes, 67.5% of those who received tapinarof achieved a 4-point or higher improvement on the scale from Week 2 through Week 12, compared to just 46.1% of patients on placebo in PSOARING 1 (p=0.0004). In PSOARING 2, 59.7% of patients in the treatment arm saw a 4-point of higher improvement, compared to 31.3% of those in the placebo arm (p<0.0001.)
Zavodnick has a distinct commercial plan in mind for tapinarof, which Vivek Ramaswamy’s team plucked from GSK back in 2018 for $330 million — $200 million upfront. The plaque psoriasis market is highly competitive, abounding with drugs from big players like Stelara, Skyrizi and Cosentyx.
Zavodnick sees the candidate as a replacement for steroids in the topical space, while leaving the most severe cases to the ultra-effective biologics, where he says the cream could act as an add-on therapy.
“I think patients that have mild to moderate psoriasis are going to look to tapinarof first-line,” he said. “If a patient needs more than a topical because of their body surface area affected, I think you’re looking at an oral/injectable opportunity, and 75% of those patients are always getting a topical with that,” adding that the beauty of nonsteroidals is there’s no limit to their use.
Dermavant announced tapinarof met its primary endpoints in PSOARING 1 and 2 back in August — clear or nearly clear cases of psoriasis compared to a placebo, with a minimum 2-grade improvement on Physician Global Assessment, a commonly used score sheet. Tapinarof also cleared a key secondary endpoint, PASI 75, at Week 12. In both PSOARING 1 and 2, tapinarof registered a 35.4% and 40.2% score on the primary, compared to marginal gains for the placebo, and a 36.1% and 47.6% score on PASI 75.
In February, Dermavant read out long-term data from the PSOARING 3 trial, which showed improvements beyond Week 12. No new safety signals were seen over the 52 weeks, and 57.3% of patients who entered the study with a PGA score of 2 or higher ended up with a score of 0 or 1, the company announced.
Patients’ symptoms didn’t flare back up for a median of four months, Zavodnick added.
The new data on itch relief set tapinarof up for a Phase III trial launch this year, Zavodnick said. Back in February, the CEO said tapinarof could be the foundation on which Dermavant builds a “multibillion-dollar organization.” After all, the company wouldn’t be a “Vant” if it didn’t promise big things at a fast pace.