MoonLake Immunotherapeutics and Stalicla gear up for Phase 2 clinical studies

MoonLake Immunotherapeutics AG is a clinical-stage biotechnology company focused on creating next-level therapies for inflammatory diseases with a major unmet need. Hidradenitis suppurativa, psoriatic arthritis, and ankylosing spondylitis (also known as radiographic axial spondyloarthritis) are among the addressed diseases.

The company’s drug candidate Sonelokimab (M1095), is an investigational Nanobody designed to treat inflammatory disease by inhibiting the naturally occurring IL-17A/A, IL-17A/F, and IL-17F/F dimers that drive inflammation. In addition, sonelokimab is designed to target sites of inflammation and penetrate difficult-to-reach inflamed tissues directly.

is proceeding with a global Phase 2 clinical study to evaluate sonelokimab in patients with moderate-to-severe hidradenitis suppurativa ("HS"). The global, randomized, double-blind, placebo-controlled study (M1095-HS-201, "MIRA") is designed 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. This study represents a landmark in HS clinical development, as it will be the first to use Hidradenitis Suppurativa Clinical Response ("HiSCR") 75 as its primary endpoint. HiSCR75 is defined as a ≥75% reduction in total abscess and inflammatory nodule (AN) count with no increase in abscess or draining tunnel count relative to baseline.

Stalicla completes Phase 1 study for the first precision medicine in autism spectrum disorder
The Swiss clinical-stage biotech company is leading omics-based drug development for patients with neurodevelopmental disorders (NDDs), with the first application in autism spectrum disorder (ASD). Its DEPI technology is the first platform specifically developed to enable precision medicine in complex NDDs. The platform integrates comprehensive metabolomics, whole-genome sequencing, RNA sequencing and its advanced HC match module to pair patient biological signatures with drug candidates. DEPI has reached clinical proof of concept with its first pipeline candidate, STP1. 

With the completion of phase 1b of STP1, the startup collected clinical data clearing the way for the first application of its precision medicine discovery platform in ASD. Phase 1b, a double-blind, placebo-controlled study, sought to evaluate the safety, tolerability, and pharmacokinetics of a two-week oral treatment with STP1 in a subgroup of patients with ASD. In addition to showing good safety and tolerability profiles and dose-dependent target engagement, STP1 treatment resulted in positive signals in clinical markers of neurological and behavioural function, including improved processing speed and crystallized cognition composite.

The company plans to start a multicenter bio sampling study for the enrollment of STP1 phase 2, to gather current comprehensive clinical and multi-omics data set in the ASD space. This will follow the STP1 phase 2, increasing treatment duration and dose level, adding a working memory test, and refining phase 1b's findings. Moreover, STALICLA plans to launch phase 2 trials for its second precision drug candidate, STP2. To finance this growth, the startup is currently raising a series B of USD 65M.

(Press release/RAN)