MoonLake Immunotherapeutics starts Phase 2 trial of the Nanobody® Sonelokimab in patients with moderate-to-severe hidradenitis suppurativa
MoonLake Immunotherapeutics has commenced a Phase 2 clinical trial for sonelokimab, a novel Nanobody® aimed at treating moderate-to-severe hidradenitis suppurativa (HS). This trial is significant as it uses the HiSCR75 endpoint, a ≥75% reduction in total abscess and inflammatory nodule count. The global trial will include over 200 patients, comparing sonelokimab to placebo and adalimumab. This milestone follows the FDA's approval of the trial protocol, with expected completion by the end of 2023. Sonelokimab targets IL-17 dimers, potentially improving outcomes for HS patients.
- First Phase 2 trial in HS using HiSCR75 as primary endpoint.
- Global trial includes over 200 patients with a structured approach to measure efficacy.
- Sonelokimab targets IL-17, potentially enhancing treatment outcomes.
- None.
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MoonLake Immunotherapeutics starts Phase 2 trial of the Nanobody® Sonelokimab in patients with moderate-to-severe hidradenitis suppurativa
- First Phase 2 trial in hidradenitis suppurativa using the higher clinical response level of HiSCR75 as the primary endpoint
- Trial evaluates sonelokimab, an investigational Nanobody® with an innovative mode of action designed to treat and elevate patient outcomes for inflammatory disease
ZUG, Switzerland, May 12, 2022 – MoonLake Immunotherapeutics AG (MoonLake; Nasdaq: MLTX), a clinical-stage biotechnology company focused on creating next-level therapies for inflammatory diseases, today announced that the first patient has been randomized and dosed, in a U.S. site, in its global Phase 2 clinical trial evaluating sonelokimab, an investigational Nanobody® designed to treat inflammatory disease, in patients with moderate-to-severe hidradenitis suppurativa (HS).
HS is a severely debilitating chronic skin condition, with a prevalence of approximately
The MIRA trial (M1095-HS-201) is a global, randomized, double-blind, placebo-controlled trial to evaluate the efficacy and safety of different doses of sonelokimab, compared with placebo, with adalimumab as an active control reference arm, in over 200 patients with HS.
This trial represents a landmark milestone in HS clinical development as it is the first to use Hidradenitis Suppurativa Clinical Response (HiSCR) 75 as its primary endpoint. HiSCR75 is defined as a ≥
The trial will also include a range of secondary endpoints reflecting the heterogeneous clinical phenotypes of the disease, including inflammatory lesions and tunnels, as well as a number of patient-reported outcome measures such as pain and quality of life assessments. The first sites of this global trial have been initiated in the United States.
Kristian Reich, Founder and Chief Scientific Officer at MoonLake, commented: “There remains an urgent need for novel treatments for hidradenitis suppurativa, a devastating skin disease that impacts approximately
The initiation of this Phase 2 trial follows the announcement in March 2022 that approval of trial protocol was obtained from the central Institutional Review Board as part of MoonLake’s Investigational New Drug (IND) filing with the U.S. Food and Drug Administration. The trial is expected to complete by the end of 2023.
About the MIRA trial
The MIRA trial (M1095-HS-201) is a global, randomized, double-blind, placebo-controlled trial to evaluate the efficacy and safety of the Nanobody® sonelokimab, administered subcutaneously, in the treatment of adult patients with active moderate to severe hidradenitis suppurativa. The trial will comprise over 200 patients, and will evaluate two different doses of sonelokimab, with placebo control and adalimumab as an active control reference arm. The primary endpoint of the trial is the percentage of participants achieving Hidradenitis Suppurativa Clinical Response 75 (HiSCR75), defined as a ≥
Further details are available on: https://www.clinicaltrials.gov/ct2/show/NCT05322473
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 naturally occurring 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, and ankylosing spondylitis (also known as radiographic axial spondyloarthritis), 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.
About Nanobodies®
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 the ability to design multivalent therapeutic molecules with bespoke target combinations.
The terms Nanobody® and Nanobodies® are trademarks of Ablynx, a Sanofi company.
About Sonelokimab
Sonelokimab (M1095) is an investigational ~40 kDa humanized Nanobody® consisting of three VHH domains 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 naturally occurring 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 has been assessed in a randomized, placebo-controlled Phase 2b trial in 313 patients with moderate-to-severe plaque-type psoriasis. Sonelokimab demonstrated a rapid and durable clinical response (Investigator’s Global Assessment Score 0 or 1, Psoriasis Area and Severity Index 90/100) in patients with moderate-to-severe plaque-type psoriasis. Sonelokimab was generally well tolerated, with a safety profile similar to the active control, secukinumab (Papp KA, et al. Lancet. 2021; 397:1564-1575).
In an earlier Phase 1 trial in patients with moderate-to-severe plaque-type psoriasis, sonelokimab has been shown to decrease (to normal skin levels) the cutaneous gene expression of pro-inflammatory cytokines and chemokines (Svecova D. J Am Acad Dermatol. 2019;81:196–203). Sonelokimab is not yet approved for use in any indication.
About Hidradenitis Suppurativa
Hidradenitis suppurativa is a severely debilitating chronic skin condition resulting in irreversible tissue destruction. HS manifests as painful inflammatory skin lesions, typically around the armpits, groin, and buttocks. Over time, uncontrolled and inadequately treated inflammation can result in irreversible tissue destruction and scarring. The disease affects 0.05–
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This press release contains certain “forward-looking statements” within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. Forward-looking statements include, but are not limited to, statements regarding MoonLake’s expectations, hopes, beliefs, intentions or strategies regarding the future including, without limitation, statements regarding: plans for clinical trials and research and development programs; and the anticipated timing of the results from those trials, including completing the MIRA trial; and the anticipated markets for products, if approved. In addition, any statements that refer to projections, forecasts, or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking statements. The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “might,” “plan,” “possible,” “potential,” “predict,” “project,” “should,” “would” and similar expressions may identify forward-looking statements, but the absence of these words does not mean that statement is not forward looking.
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