MoonLake Immunotherapeutics reports on week 16 results of the VELA Phase 3 hidradenitis suppurativa program with the Nanobody® sonelokimab

About this update from Moonlake Immunotherapeutics

VELA-1 and VELA-2 are two identical trials to evaluate the efficacy and safety of sonelokimab in adult participants with moderate to severe hidradenitis suppurativa (HS) and the first Phase 3 program using the higher clinical response level of HS Clinical Response (HiSCR) 75 as primary endpoint at week 16 Data was analyzed, as per protocol and in accordance with regulatory agency feedback, using a composite strategy as the primary analysis and a treatment policy strategy to test the robustness of the results: difference between the two methods relates to the statistical handling of intercurrent events In the combined VELA program, patients treated with sonelokimab experienced a clinically meaningful and statistically significant improvement across all primary and key secondary endpoints using both pre-specified strategies (p4, as well as other scores that reflect the evolving needs of HS patients, treating physicians and regulators. These included the percentage of participants achieving at least a 55% reduction in the International HS Severity Scoring System (IHS4-55), the percentage of participants achieving at least a 3 point improvement from baseline in the worst pain Numerical Rating Scale (NRS) among participants with a baseline score of at least 3 points, and the change from baseline in the HS-specific Quality of Life score (HiSQOL). A total of 838 patients were enrolled across both trials. The trials were identical in design comparing a single 120mg dose of sonelokimab to placebo with HiSCR75 reading out at week 16. From week 16, all patients receive the 120mg dose of sonelokimab through to 48 weeks, with a last assessment at week 52, followed by an open-label extension for up to two years. The Phase 3 program used a protocol design consistent with the Phase 2 MIRA trial, which identified the optimal dose of sonelokimab for HS. The VELA protocols and statistical analysis plans were prepared in accordance with regulatory agency advice and include two analysis strategies. The composite strategy for the VELA trials is the primary statistical analysis. The protocol specifies the treatment policy strategy as the alternative method of handling intercurrent events to test the robustness of the VELA data. Data in this press release is presented using the aforementioned analysis strategies, as indicated throughout. The baseline characteristics for VELA-1 and VELA-2 are shown in Table 1. TABLE 1 Baseline Characteristics Trials VELA 1 VELA 2 Placebo(n=138) SLK(n=283) Placebo(n=141) SLK(n=276) Age [years], mean 36.1 37.2 38.0 37.2 Female , % 62.3 61.5 49.6 53.6 Race, % White Black or African American 76.1 15.2 77.7 12.0 85.1 10.6 81.5 9.4 BMI , mean 33.6 33.5 32.7 33.0 Current smoker , % 41.3 43.8 56.0 51.8 Hurley Stage , % II III 63.8 36. 64.0 36.0 67.4 32.6 63.0 37.0 Years since diagnosis , mean 8.4 8.1 7.7 7.5 Lesions, mean AN count DT count 13.3 2.8 13.5 3.2 13.8 3.5 14.5 3.9 DLQI Total , mean 11.8 11.7 11.3 12.6 HiSQOL Total , mean 27.6 26.5 23.8 28.0 Patient Global Assessment of Skin Pain NRS , mean 4.9 4.7 5.0 4.9 Prior biologic use , % 15.9 15.5 22.0 19.6 Concomitant antibiotics , % 8.7 6.7 7.8 10.5 In the combined Phase 3 VELA program, all endpoints reached statistical significance with p-values below 0.001, including lesion counts and patient reported outcomes (PROs), as per Table 2. Sonelokimab demonstrated the expected profile of response over time, with statistically significant HiSCR75 for both studies achieved as early as week 4 (Table 3). A preliminary analysis suggests that responses continue to improve beyond week 16 and that placebo patients crossing over at week 16 achieve similar responses to those originally randomized to the sonelokimab 120mg arm, as of week 20 (pre-specified analysis, data not shown). Using the treatment policy strategy as per protocol, both VELA-1 and VELA-2 showed a statistically significant increase in the percentage of participants achieving HiSCR75 at week 16 and provided a clinically meaningful benefit (Table 2). Response rates for sonelokimab 120mg were consistent between the two trials, with 34.8% and 35.9% of patients in VELA-1 and VELA-2 achieving HiSCR75 at week 16, respectively. The placebo response rate in VELA-1 of 17.5% at week 16 was within the historical Phase 3 range of 13% to 18%. The placebo response rate in VELA-2 of 25.6% at week 16 was higher than expected. Both VELA-1 and VELA-2 achieved statistical significance for all key secondary endpoints (Table 2). This includes other lesion count based endpoints (HiSCR50 and IHS4-55). It also includes relevant PROs in HS. Around 30% of patients experienced a marked reduction of pain, as measured by an at least 3-point improvement in the worst pain NRS, in both VELA-1 and VELA-2 (p≤0.002). Sonelokimab showed a significant improvement of HiSQOL score at week 16 (p

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