Steven Stein
Executive Vice President & Chief Medical Officer at Incyte
Thank you, Pablo. Starting on Slide 19. As Herve mentioned, we obtained the topline results from the Phase 2 randomized, double-blind, placebo-controlled, dose-ranging study assessing the efficacy and safety of povorcitinib in patients with prurigo nodularis. The study met the primary endpoint for all povorcitinib doses studied of 15 milligrams, 45 milligrams and 75 milligrams and at Week 16, 36.1%, 44.4% and 54.1% of patients, respectively, achieved the primary endpoint versus an 8.1% rate for patients on placebo. The primary endpoint was designed to assess the proportion of patients achieving a greater than or equal to 4-point improvement in itch at Week 16.
Povorcitinib was generally well tolerated across all doses and the safety analyses were consistent with previously presented data with no new reported treatment-emergent adverse events. We plan on presenting the full data set at an upcoming medical conference in the first half of 2024. As a result of these very encouraging findings, plans are underway to initiate a Phase 3 study in 2024.
We had a significant presence at the European Academy of Dermatology and Venereology Congress earlier this month, which highlighted our commitment to the atopic dermatitis and vitiligo communities. In a late-breaking oral presentation, we presented positive 52-week data from a Phase 2b clinical trial evaluating the safety and efficacy of povorcitinib in adult patients with extensive non-segmental vitiligo. These results show that treatment with oral povorcitinib was associated with substantial total body and facial re-pigmentation across all treatment groups at week 52 and was well-tolerated at all doses throughout the study.
During the 24-week post-treatment period, total body and facial re-pigmentation was also maintained, which suggests durability of response following treatment discontinuation. These data further reinforced the efficacy and safety profile of povorcitinib as an oral treatment for patients with extensive non-segmental vitiligo, and we plan to initiate the Phase 3 study by the end of this calendar year.
Povorcitinib has already demonstrated outstanding efficacy in the Phase 2 program in hidradenitis suppurativa. As a reminder, 52% to 56% of patients treated with povorcitinib achieved a HiSCR50 at Week 16 with responses improving to 59% to 67% at Week 52. Additionally, HiSCR100 response which is complete resolution of all manifestations of the disease was reported at Week 52 in up to 29% of patients. The two Phase 3 studies STOP-HS1 and STOP-HS2 are enrolling very well and this reflects the strong Phase 2 data presented earlier this year.
We continue to expand the povorcitinib program focused on the science while leveraging our extensive dermatology capabilities. We look forward to advancing the development of povorcitinib in areas of unmet need where it is currently being evaluated in two Phase 3 studies in HS and moving into a Phase 3 program for vitiligo and prurigo nodularis. Work continues in the Phase 2 proof-of-concept studies in asthma and chronic spontaneous urticaria.
Moving to ruxolitinib cream on Slide 23. Also presented at EADV with expanded results from the pivotal Phase 3 TRuE-AD3 study, evaluating the safety and efficacy of ruxolitinib cream in children 2 years to 12 years old with atopic dermatitis. These data showed significantly more patients treated with ruxolitinib cream 0.75% and 1.5% achieved Investigator's Global Assessment treatment success than patients treated with placebo. Treatment with ruxolitinib cream over 8 weeks under maximum use conditions was also well-tolerated in children. Expert feedback on the data has been consistently positive namely that ruxolitinib cream could be advantageous to the currently available non-steroidal topical options and an important option before resorting to currently available injectables. We are excited about the potential relief ruxolitinib cream can bring to the over 2 million pediatric atopic dermatitis patients in the United States.
As a late-breaking oral presentation at EADV, new results from the pooled analysis of the long-term extension data from the pivotal Phase 3 TRuE-V program were presented. The long-term study extension evaluate Opzelura in patients 12 years and older with non-segmental vitiligo who previously experienced limited or no response to treatment at Week 24. The data demonstrated that prolonged treatment of ruxolitinib cream led to increased facial and total body re-pigmentation in those patients who were initial non-responders. Approximately 70% of patients saw improvements in facial VASI and total VASI at Week 52, which increased to 85% by Week 104.
Throughout the long-term extension, Opzelura continued to be well-tolerated with no serious treatment-related adverse events. This data highlights the importance of prolonged treatment in patients with vitiligo even when limited or no re-pigmentation is achieved in the first six months of treatment.
On Slide 25, we continue to advance Opzelura development beyond AD and vitiligo and into other indications where there is the potential to provide significant value as either the first approved therapy or first approved topical therapy for patients living with these dermatologic conditions. We currently have three Phase 2 studies, which have recently completed enrollment in lichen planus, lichen sclerosus and mild to moderate HS, and two additional Phase 3 trials evaluating Opzelura in prurigo nodularis, which are all currently enrolling patients.
Finally, on Slide 26, we have a number of upcoming data readouts and other exciting milestones expected, and we look forward to sharing additional details throughout the remainder of this year.
With that, I would like to turn the call over to Christiana for the financial update.
