Full Press Release Details
MoonLake Immunotherapeutics Announces
Positive Outcome from Type B Meeting with U.S. FDA and Announces Investor Day
ZUG, Switzerland, January 8, 2026 -
MoonLake Immunotherapeutics (NASDAQ:MLTX) ("MoonLake" or the "Company"), a clinical-stage biotechnology company
focused on creating next-level therapies for inflammatory diseases, today provided an update following the positive feedback received
from the U.S. Food and Drug Administration (FDA) regarding the clinical evidence strategy for SLK in HS, based on the Type B meeting requested
SLK was associated with significant improvements
across different key outcomes in over 1,000 patients with HS enrolled in the MIRA, VELA-1 and VELA-2 trials. MIRA was the first placebo-controlled
randomized clinical trial in HS using HiSCR75 as the primary endpoint and demonstrated a 43% response with 120mg SLK, and a 29 ppt delta
vs placebo (p < 0.001) at week 12. VELA-1 met all primary and key secondary endpoints with statistical significance across all pre-specified
analysis strategies (HiSCR75 at Week 16, 35% response with 120mg SLK, delta to placebo of 17ppt, p < 0.001). In VELA-2, using the pre-specified
treatment policy strategy, SLK achieved statistical significance (HiSCR75 at Week 16, 36% response with 120mg SLK, delta to placebo of
10ppt, p = 0.033). A higher-than-expected placebo response precluded this study from achieving statistical significance using the primary
composite analysis method (delta to placebo of 9%, p=0.053). All trials consistently suggested a favorable safety profile of SLK in HS
To obtain regulatory clarity following the VELA
readout and to continue the preparation of the BLA, MoonLake requested a Type B meeting with the FDA. The Company submitted a detailed
briefing book with several additional analysis of the VELA data. The FDA indicated that MoonLake may establish substantial evidence of
effectiveness (SEE) without additional clinical trials in HS, with an application consisting of data from its existing VELA-1, VELA-2
and MIRA trials. This supports the Company's perspective regarding the relevance of MIRA results for the HS BLA submission. In addition,
the FDA advised the Company that the results of VELA-2 trial should be submitted for the marketing application to inform the safety of
SLK, regardless of decisions on its utility in establishing SEE. The FDA further excluded using mechanistic evidence as confirmatory evidence,
in combination with results from a single clinical trial, to establish SEE for the HS indication. Based on the final official records
of this Type B meeting, MoonLake will continue its planned preparations for BLA submission.
Dr. Jorge Santos da Silva, Founder and Chief
Executive Officer at MoonLake Immunotherapeutics, said: "The positive outcome of our Type B meeting with the FDA provides
the clarity needed to support a pathway to approval for our existing HS program, with no additional clinical trials required. In addition,
the fact that we can prepare the BLA with the wealth of data across the VELA and MIRA trials provides us and the FDA with flexibility
to determine the best label possible, so that SLK, if approved, can have the most positive impact for HS patients. Overall, this also
provides a strong base for MoonLake to continue the broader development of SLK in other indications."
Prof. Kristian Reich, Founder and Chief Scientific
Officer at MoonLake Immunotherapeutics, said: "The FDA has provided us with clear and helpful feedback indicating that the
MIRA and VELA trials, which together enrolled more than 1000 patients with moderate-to-severe HS and tested sonelokimab using similar
study designs, provide a basis for BLA submission. The FDA recognizes that MIRA and VELA-1, which met their primary and important key
secondary endpoints, together with VELA-2, can be used to establish substantial evidence of effectiveness, and that VELA-2 provides a
key source of evidence to inform, for example, the safety of sonelokimab. The encouraging feedback matches our view of the strong performance
of sonelokimab in HS across three trials and we are looking forward to further engaging with the FDA prior to the BLA submission."
The preparations for the submission of the BLA
continue as planned and are on track for submission in H2 2026.
The company will hold an Investor Day on February
23rd, 2026 at 8 am EST / 2pm CET, to further discuss the outcomes of this Type B FDA Meeting and to present new clinical data
for SLK across indications. The Company will also provide further details on the catalyst calendar for 2026 and beyond. The details for
this Investor Day will be announced in due course.
Other clinical trials of SLK are progressing and
are expected to support a catalyst-rich roadmap over the next 12 months, including data releases from the Phase 2 S-OLARIS trial in Axial
Spondyloarthritis (axSpA) and the Phase 3 IZAR trials in Psoriatic Arthritis (PsA), among others.
Important upcoming anticipated milestones for
About MoonLake Immunotherapeutics
MoonLake Immunotherapeutics is a clinical-stage
biopharmaceutical company unlocking the potential of sonelokimab, a novel investigational Nanobody for the treatment of
inflammatory disease, to revolutionize outcomes for patients. Sonelokimab inhibits IL-17A and IL-17F by inhibiting the IL-17A/A, IL-17A/F,
and IL-17F/F dimers that drive inflammation. The Company's focus is on inflammatory diseases with a major unmet need, including
hidradenitis suppurativa, psoriatic arthritis, axial spondyloarthritis and palmoplantar pustulosis - conditions affecting millions
of people worldwide with a large need for improved treatment options. MoonLake was founded in 2021 and is headquartered in Zug, Switzerland.
Further information is available at www.moonlaketx.com.
Nanobodies represent a new generation
of antibody-derived targeted therapies. They consist of one or more domains based on the small antigen-binding variable regions of heavy-chain-only
antibodies (VHH). Nanobodies have a number of potential advantages over traditional antibodies, including their small
size, enhanced tissue penetration, resistance to temperature changes, ease of manufacturing, and their ability to be designed into multivalent
therapeutic molecules with bespoke target combinations.
The terms Nanobody and Nanobodies
are trademarks of Ablynx, a Sanofi company.
Sonelokimab (M1095) is an investigational ~40
kDa humanized Nanobody consisting of three VHHs covalently linked by flexible glycine-serine spacers. With two domains,
sonelokimab selectively binds with high affinity to IL-17A and IL-17F, thereby inhibiting the IL-17A/A, IL-17A/F, and IL-17F/F dimers.
A third central domain binds to human albumin, facilitating further enrichment of sonelokimab at sites of inflammatory edema.
Sonelokimab is being assessed in two lead indications,
hidradenitis suppurativa (HS) and psoriatic arthritis (PsA), and the Company is pursuing other indications in dermatology and rheumatology,
including adolescent HS, palmoplantar pustulosis (PPP) and axial spondyloarthritis (axSpA).
For adults with HS, sonelokimab is being assessed
in two identical Phase 3 trials, the VELA-1 and VELA-2 trials, using the higher clinical response level of HS Clinical Response (HiSCR)
75 as the primary endpoint, which defines a response as an at least 75% reduction in abscess and inflammatory nodule count, with no increase
from baseline in abscess or draining tunnel count. In September 2025, the primary endpoint data from the VELA-1 and VELA-2 clinical trials
were announced. In the combined VELA program, patients treated with SLK experienced a clinically meaningful and statistically significant
improvement across all primary and key secondary endpoints using both pre-specified strategies (p<0.001). In VELA-1, SLK achieved statistical
significance for all primary and key secondary endpoints using both pre-specified strategies (HiSCR75, delta to placebo of 17%, p<0.001).
In VELA-2, intercurrent events in the higher-than-expected placebo arm precluded the study from achieving statistical significance in
the week 16 primary endpoint using the composite strategy (HiSCR75, delta to placebo of 9%, p=0.053). From week 16, all patients are expected
to continue to receive the 120mg dose of SLK through to 48 weeks, with a last assessment planned at week 52, followed by an open-label
extension for up to two years. The safety profile of sonelokimab in the VELA trials was consistent with previous trials with no new safety
Sonelokimab is currently undergoing evaluation
in the VELA-TEEN Phase 3 trial, which is the first clinical study specifically focused on adolescent patients with moderate-to-severe
For PsA, sonelokimab is being assessed in the
Phase 3 trials, IZAR-1 and IZAR-2, following the announcement in March 2024 of the full dataset from the global Phase 2 ARGO trial (M1095-PSA-201)
evaluating the efficacy and safety of the Nanobody sonelokimab over 24 weeks in patients with active PsA. Significant
improvements were observed across all key outcomes, including approximately 60% of patients treated with sonelokimab achieving an American
College of Rheumatology (ACR) 50 response and Minimal Disease Activity (MDA) at week 24. This followed the positive top-line results in
November 2023, where the trial met its primary endpoint with a statistically significant greater proportion of patients treated with either
sonelokimab 60mg or 120mg (with induction) achieving an ACR50 response compared to those on placebo at week 12. All key secondary endpoints
in the trial were met for the 60mg and 120mg doses with induction. The safety profile of sonelokimab in the ARGO trial was consistent
with previous trials with no new safety signals detected.
Sonelokimab is also being assessed in the Phase
2 LEDA trial, which is ongoing for PPP, a debilitating inflammatory skin condition affecting a significant number of patients.
Additionally, Sonelokimab is being assessed in
the ongoing Phase 2 S-OLARIS and P-OLARIS trials for active axSpA and PsA, respectively. Both trials feature an innovative design complementing
traditional clinical outcomes with cellular imaging techniques.
Sonelokimab has also been assessed in a randomized,
placebo-controlled third-party 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 generally presented a safety profile similar to the active control,
secukinumab (Papp KA, et al. Lancet. 2021; 397:1564-1575).