MoonLake’s Sonelokimab Trial for HS Advances to Phase 3

MoonLake Immunotherapeutics recently announced that the first patients have been screened at a US trial site in its global phase 3 trial, VELA, evaluating the safety and efficacy of sonelokimab for the treatment of moderate to severe hidradenitis suppurativa (HS). After positive results from the phase 2 MIRA trial, sonelokimab advances into phase 3 VELA, which is expected to enroll 800 patients across VELA-1 (NCT06411899) and VELA-2 (NCT06411379).¹

Both VELA trials are identical in design of comparing a single 120mg dose of sonelokimab to placebo with the higher measure of clinical response, Hidradenitis Suppurativa Clinical Response (HiSCR) 75, defined as a ≥75% reduction in total abscess and inflammatory nodule count with no increase in abscess or draining tunnel count relative to baseline, as the primary end point at week 16. VELA is the first phase 3 hidradenitis suppurativa trial to evaluate HiSCR75 as the primary end point.

Key secondary end points include the proportion of patients achieving HiSCR50, the change from baseline in International Hidradenitis Suppurativa Severity Score System, the proportion of patients achieving a Dermatology Life Quality Index total reduction of ≥4, the proportion of patients achieving at least 50% reduction from baseline in Numerical Rating Scale in the Patient’s Global Assessment of Skin Pain, and complete resolution of Draining Tunnels.

After week 16, all patients will receive 120mg of sonelokimab through week 52, followed by an open-label extension for up to 2years. VELA will use a protocol design consistent with the phase 2 MIRA trial (NCT05322473), which identified the optimal dose of sonelokimab for HS. The topline primary endpoint data from week 16 of VELA is expected to be announced in mid-2025.

“HS is a chronic inflammatory skin condition with a range of debilitating symptoms including pain, malodorous drainage, low mood, and depression. With only two FDA approved biologics, there is still an urgent need for new treatment options that treat all patient types and lesions, with the opportunity for inflammatory remission. The unique characteristics and mode of action of MoonLake’s Nanobody, sonelokimab to effectively inhibit IL-17F in addition to IL-17A in deep tissue inflammation has to date shown promising outcomes, highlighting the importance of this phase 3 program, and placing HS at the forefront of dermatological innovation,” said Hadar Lev-Tov, MD, MAS, associate professor of clinical dermatology and cutaneous surgery at the Miller School of Medicine in Miami, Florida, and president Hidradenitis Suppurativa Foundation, in the news release.

The advancement of the phase 3 trial follows MoonLake’s announcement in February 2024 of positive feedback from the US Food and Drug Administration and European Medicines Agency of their support of MoonLake’s phase 3 program evaluating sonelokimab.1

“It is with great enthusiasm that I am participating as an investigator in the Phase 3 VELA program investigating the Nanobody sonelokimab for HS, signifying a substantial advancement in addressing the critical unmet need for more treatment options for individuals living with HS. As a physician, I witness first-hand the immense demand for novel treatment options for people living with HS, particularly those that can achieve elevated response thresholds (eg, HiSCR75 and beyond). The findings from the phase 2 MIRA trial offer valuable insights into what may be possible as we work with our patients to establish more ambitious treatment goals and alleviate the disease burden of this debilitating condition,” said Seth B Forman, MD, principal investigator at CenExel-FCR, in the news release.

Last month, MoonLake announced its new partnership with Komodo Health to advance research and treatments of inflammatory skin and joint diseases, such as HS, psoriasis, and psoriatic arthritis. MoonLake and Komodo’s collaboration will help to increase the impact of sonelokimab for disease states with high unmet patient needs.²

Additional Indications

MoonLake is also evaluating sonelokimab for the treatment of psoriatic arthritis in its phase 2 ARGO trial (NCT05640245) and expects to advance sonelokimab into phase 3 trials in the fourth quarter of 2024. In phase 2, significant improvements were observed across all key end points, including approximately 60% of patients treated with sonelokimab achieving an American College of Rheumatology 50 response and Minimal Disease Activity at week 24.¹

Sonelokimab has been evaluated in a randomized, placebo-controlled phase 2b trial (NCT03384745) in 313 patients with moderate to severe plaque-type psoriasis. High threshold clinical responses (Investigator’s Global Assessment Score 0 or 1, and Psoriasis Area and Severity Index 90/100) were observed in patients with moderate to severe plaque-type psoriasis. Sonelokimab was generally well tolerated, with a safety profile similar to the active control, secukinumab.¹

References

1. MoonLake Immunotherapeutics starts phase 3 VELA program of the nanobody sonelokimab in patients with moderate-to-severe hidradenitis suppurativa. News release. BioSpace. May 16, 2024. Accessed May 16, 2024. https://www.biospace.com/article/releases/moonlake-immunotherapeutics-starts-phase-3-vela-program-of-the-nanobody-sonelokimab-in-patients-with-moderate-to-severe-hidradenitis-suppurativa/
2. MoonLake Immunotherapeutics inks three-year technology partnership with Komodo Health to advance research on inflammatory skin and joint conditions. News release. MoonLake Immunotherapeutics. April 10, 2024. Accessed May 16, 2024. https://ir.moonlaketx.com/press-releases