Months after touting positive data from two pivotal Phase IIIs, Vivek Ramaswamy’s Dermavant team is back with long-term data to back its psoriasis candidate tapinarof — and it’s headed for the FDA.
About 91% of the 1,025 patients in Dermavant’s PSOARING 1 and 2 Phase III studies opted to roll into PSOARING 3, a long-term safety analysis, CEO Todd Zavodnick said. But the study ended up being much more than a safety trial.
“It really allowed us to confirm trends, and a hypothesis that we formed in earlier trials around our efficacy, durability, and then our remittance,” Zavodnick said.
While patients in PSOARING 1 and 2 were followed for 12 weeks, an interim analysis of PSOARING 3 showed improvements beyond Week 12, according to Dermavant. No new safety signals were seen over the 52 weeks, and 57.3% of patients who entered the study with a Physician Global Assessment (PGA) score of 2 or higher ended up with a PGA score of 0 or 1, the company announced.
Patients’ symptoms didn’t flare back up for a median of four months, Zavodnick added.
Dermavant also conducted an integrated efficacy analysis with data from PSOARING 1 and 2, and the interim data from PSOARING 3. They found that PASI-75 — a 75% reduction in Psoriasis Area and Severity Index score — was achieved by 63.5% of patients. PASI-90, at any time point, was achieved by 44.2% of patients.
“In our pivotal trials, in the Phase III pivotals as well as in the Phase IIb trials, we saw glimpses of durability and remittance … Patients were getting better on the drug, and there was no tachyphylaxis with the drug. But we wanted to confirm it,” Zavodnick said.
The company plans on filing an NDA in the first half of this year.
Tapinarof is a once-daily, “cosmetically elegant” vanishing cream, which Ramaswamy plucked from GSK for $330 million — $200 million upfront. Zavodnick is lining it up to replace steroids in the topical space. The most severe psoriasis patients can graduate to ultra-effective biologics, he says, where he still sees a role for the cream as an add-on therapy.
“Patients that have severe … large body surface areas of impact, they’re still going to get orals and they’re still going to get injectables. But they’re going to be getting an accompanied nonsteroidal topical that they could use for as long as they want. And I think that’s the beauty of nonsteroidals. There’s no limit to usage, where with steroids, they’re limited,” Zavodnick said.
With plans to initiate a Phase III trial in atopic dermatitis this year, Zavodnick says tapinarof could be the foundation on which Dermavant builds a “multibillion-dollar organization.” It’s a tall order — but the company wouldn’t be a “Vant” if it didn’t promise big things at a fast pace. Ramaswamy, who founded Roivant on the idea that he could polish drugs off the Big Pharma discard lane, announced earlier this year that he’s stepping back to devote more time to the political sphere.