Steven Stein
Executive Vice President and Chief Medical Officer at Incyte
Thank you, Barry and good morning, everyone. We recently presented positive Phase 2 data of povorcitinib in hidradenitis suppurativa at the 2022 European Academy of Dermatology and Venereology Congress which demonstrated that patients on povorcitinib had significantly greater decreases in total abscess and inflammatory nodules count versus placebo from baseline to week 16. In addition, HS clinical response or HiSCR which is defined as a greater than or equal to 50% reduction in the total abscess and inflammatory nodules count and no increase in abscess count or draining fistulas compared to baseline was achieved in a greater percentage of povorcitinib patients than placebo at week 16.
Hidradenitis suppurativa represents a significant opportunity where there are more than 150,000 patients with moderate-to-severe disease in the United States. In October, our pivotal Phase 3 data of ruxolitinib cream in vitiligo was published in the New England Journal of Medicine and these data highlight the positive efficacy and safety profile of Opzelura as a treatment for repigmentation in vitiligo. The MAA for Opzelura in vitiligo is under review and we expect a regulatory decision in the first half of next year.
Moving to slide 16. Last month, we announced our agreement to acquire Villaris Therapeutics and their lead asset, auremolimab, a highly potent and selective anti IL-15 receptor beta monoclonal antibody. IL-15 signaling occurs upstream of the JAK/STAT pathway and demonstrates a strong scientific rationale for the evaluation of IL-15 blockade in vitiligo and other dermatologic conditions. In vitiligo, preclinical data suggests that maintenance and relapse is driven by resident memory T-Cells for TRM in the skin. IL-15 is critical for the survival of TRM and IL-15 blockade may result in the depletion of resident memory T-cells leading into a longer and more durable repigmentation effect. The addition of auremolimab to our dermatology portfolio bolsters our commitment to patients living with vitiligo and potentially offers optionality based on severity of disease as well as different dosing options that may allow for combination therapy, all of which is complementary to our JAK franchise. We are planning on entering clinical development with auremolimab in 2023.
On slide 17 is an updated table of our extensive clinical development pipeline in dermatology. With regards to ruxolitinib cream in hand eczema after discussions with the FDA, it was deemed not necessary to run larger Phase 3 clinical trial in chronic hand eczema as the indication is covered by the current label. We've also added two new indications in the development plan for ruxolitinib cream with two Phase 2 trials in preparation for lichen sclerosus and lichen planus. Additionally auremolimab in vitiligo has been included which is expected to enter clinical development in 2023 as I mentioned earlier.
Turning to slide 18 and axatilimab. As a reminder the Phase 1/2 study in chronic graft-versus-host disease this was an open-label study evaluating axatilimab an anti CSF1-R antibody in patients six years and older with active chronic graft-versus-host disease in the third-line plus setting. In this heavily pre-treated patient population, axatilimab monotherapy resulted in a best overall response rate of 68% across both doses of one milligram per kilogram every two weeks and three milligrams per kilogram every four weeks. Fifty three percent of patients reported a clinical meaningful improvement in their symptoms via the Lee Symptom Score. Axatilimab was also well tolerated and demonstrated an acceptable safety profile with no viral reactivations in this study. Looking ahead, we anticipate data from the ongoing AGAVE-201 pivotal trial in chronic graft-versus-host disease in mid-2023 and that's a potential BLA filing later in 2023. In addition the combination trial of axatilimab and ruxolitinib in steroid-naive chronic graft-versus-host disease is in preparation with an expected initiation in the first quarter of next year.
On the next slide and our progress in myeloproliferative neoplasms in graft-versus-host disease in general, we continue to advance our LIMBER pipeline and expect to achieve many important milestones in the remaining months of 2022 and into 2023. The Phase 1 study of ruxolitinib in combination with Cellenkos' CK0804 in myelofibrosis has initiated with the first patient dosed in October. Later this year, we expect to present initial data from the BET and ALK2 programs. The target action date for once-daily ruxolitinib is March 23, 2023 and we expect topline results from the Phase 3 study of parsaclisib plus ruxolitinib in inadequate responders in 2023 as well.
Turning to slide 20 and our oral PD-L1 program. We continue to progress the development of our oral PD-L1 program with two compounds, 280 and 318 which have been prioritized based on observation of tumor shrinkage and to date no evidence of peripheral neuropathy with either compound. We will be presenting updated data on both compounds at the Society for Immunotherapy of Cancer Annual Meeting in Boston next week. The third quarter was successful for Incyte across regulatory, clinical and business development and we are looking forward to an exciting close to the year.
I'd like to turn the call over to Christiana for the financial update.
