Incyte keeps rolling on topical cream for JAK inhibitor, passing two PhIII tests in vitiligo
As Incyte prepares to potentially hit the market with a topical formulation of its cash cow ruxolitinib in atopic dermatitis, the Wilmington, DE-based company is beefing up its data package for another indication: vitiligo.
Incyte released Phase III results from two of its clinical vitiligo programs Monday morning, saying both studies met their primary endpoints of patients achieving at least 75% improvement from baseline in repigmentation of the face. The data will likely lead Incyte to ask for approval in both the US and Europe for those older than 12 before the end of the year.
The FDA is currently reviewing the ruxolitinib cream in an NDA for AD, which received priority review thanks to a voucher used by Incyte. Incyte submitted the NDA in December, and the PDUFA date for AD is June 21.
Monday’s results come from the two trials that looked at 300 patients each, requiring individuals to meet certain inclusion criteria for how much of their skin was affected by the condition. They were randomized into two arms, one using 1.5% ruxolitinib cream twice a day and the other utilizing a control for 24 weeks. Both studies hit sparkling p-values of p<0.0001.
The 75% number is measured by a scoring index similar to those used in other skin conditions like eczema and psoriasis, inflammation and autoimmunity chief Jim Lee told Endpoints News. That figure represents the point at which both patients feel a meaningful benefit and researchers see less “background noise” in regards to a placebo effect, he said.
Secondary endpoints in the studies included patients who saw at least 50% and 90% improvement from baseline, two other benchmarks that had been debated in the past, and Incyte hit statistical significance in these too.
Ruxolitinib, sold as Jakafi in the US and Jakavi by Novartis elsewhere, has long been a money maker for Incyte. Originally approved in 2011 to treat myelofibrosis, the drug is a JAK inhibitor targeting JAK1 and JAK2. Since then, it gained the FDA OK in polycythemia vera in 2014 and acute graft-versus-host disease in 2019.
But the topical version has represented a new push for ruxolitinib into areas that present much differently than its other indications. Whereas the first three areas all have to do with blood cancers and transplant rejections, AD and vitiligo are skin conditions, the latter of which can result in patients’ loss of skin pigmentation in many parts of the body.
For Incyte, it didn’t make sense to develop oral ruxolitinib in these indications, Lee said. The topical formulation can be applied directly to the affected areas while limiting the exposure that other administration methods might have had.
Additionally, this cream is only for use in mild to moderate cases of vitiligo, where affected areas make up about 10% to 20% of a patient’s body. In AD, that also might translate into something where patients’ only affected areas are on their elbows or behind their knees, Lee added. And there’s the common JAK denominator involved in all of the diseases, too.
Regarding the severe cases, “It’s not very practical to lather a cream all over your body twice a day for an extended period of time,” Lee said. “But we know that 90% of patients or more have limited disease, and cream you can apply to those limited areas is really a very sensible, practical approach.”
Incyte had long been struggling to develop new drugs, with Jakafi being its only approved product through the end of 2019. But last year came two new approvals — Pemazyre for bile duct cancer, and the MorphoSys-partnered Monjuvi for refractory diffuse large B-cell lymphoma.