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MoonLake Immunotherapeutics reports clinical, regulatory and financing developments for a clinical-stage biotechnology business focused on inflammatory skin and joint diseases. Its updates center on sonelokimab (SLK), a Nanobody designed to inhibit IL-17A and IL-17F, and on programs in hidradenitis suppurativa, psoriatic arthritis, axial spondyloarthritis and palmoplantar pustulosis.
Recurring news includes Phase 2 and Phase 3 trial data from VELA, VELA-TEEN, MIRA, LEDA, S-OLARIS and IZAR studies, FDA interactions and designations tied to SLK, quarterly financial results, research and development spending, equity and debt financing activity, and shareholder voting or capital-structure matters.
MoonLake Immunotherapeutics (NASDAQ:MLTX) reported its Q2 2024 financial results and announced a Capital Markets Update for September 11. Key highlights include:
1. Initiation of Phase 3 VELA program for sonelokimab in hidradenitis suppurativa (HS), with topline results expected mid-2025.
2. Positive feedback from FDA and EMA on the regulatory path for Phase 3 program in psoriatic arthritis (PsA).
3. $519.8 million in cash and equivalents, providing runway to end of 2026.
4. R&D expenses increased to $23.7 million, while G&A expenses remained stable at $6.9 million.
5. Upcoming events include initiation of Phase 3 IZAR program in PsA and additional Phase 2 trials in various indications.
MoonLake Immunotherapeutics has received positive regulatory feedback from both the FDA and EMA for its Phase 3 program of Nanobody® sonelokimab targeting psoriatic arthritis (PsA). The program, named IZAR, will enroll around 1,500 patients across two trials (IZAR-1 and IZAR-2). IZAR-1 will focus on bio-naïve patients and radiographic progression, while IZAR-2 will involve TNF-IR patients with risankizumab as a reference arm. The primary endpoint readout is anticipated by end-2026. This follows earlier positive feedback for their Phase 3 VELA program for hidradenitis suppurativa (HS). Recruitment for these trials is set to begin in Q4 2024.
MoonLake Immunotherapeutics has launched the Phase 3 VELA program, testing the Nanobody® sonelokimab in patients with moderate-to-severe hidradenitis suppurativa (HS). The program aims to enroll 800 patients and is expected to report its topline primary endpoint at week 16 by mid-2025. Sonelokimab targets inflammation by inhibiting IL-17A/A, IL-17A/F, and IL-17F/F dimers. The Phase 3 program, following the successful Phase 2 MIRA trial, will use HiSCR75 as its primary endpoint. The trial will last 52 weeks, with an open-label extension up to two years.
MoonLake Immunotherapeutics reported positive feedback on the regulatory path for the Phase 3 program of Nanobody® sonelokimab, significant improvements in ARGO Phase 2 trial, and plans to commence four additional clinical trials across dermatology and rheumatology. The company ended Q1 2024 with $547.1 million in cash and expects a cash runway to the end of 2026.
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