MoonLake debuts with Cosentyx challenger from Merck KGaA

Zug, Switzerland-based MoonLake Immunotherapeutics plans to start multiple phase 2 studies for sonelokimab soon. (Tao Gutekunst / Pixabay)

MoonLake Immunotherapeutics launched on Monday with backing from BVF Partners and a mission to develop single-domain antibodies or “nanobodies” for several inflammatory diseases. Its first program? A nanobody licensed from Merck KGaA that’s already been tested in phase 2.

That nanobody, sonelokimab, targets two members of the IL-17 family of inflammation-promoting cytokines, IL-17A and IL-17F. Merck KGaA, which licensed the nanobody from Ablynx in 2013, brought it through a phase 2b study in more than 300 patients with moderate to severe psoriasis. That trial tested four dose levels of sonelokimab against placebo and Novartis’ Cosentyx.

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After 12 weeks, sonelokimab beat placebo on multiple measures, according to data Merck KGaA presented in October. More patients taking the nanobody achieved clear or almost clear skin, as measured by the investigator’s assessment of the extent of their psoriasis, with at least a two-point improvement from their baseline. And more patients taking sonelokimab than placebo logged 75% and 90% reductions in symptoms compared to those taking placebo.

The drug did “numerically” better than Cosentyx in the study, Zug, Switzerland-based MoonLake said in a statement on Monday (this means however that while it outperformed Cosentyx, this was not by enough to reach statistical significance).

MoonLake will build of Ablynx and Merck KGaA’s work with plans to develop sonelokimab for inflammatory skin and joint diseases such as psoriatic arthritis; ankylosing spondylitis, which can cause some vertebrae to fuse; and hidradenitis suppurativa, a skin condition that leads small, painful lumps to form under the skin. The company plans to start multiple phase 2 studies soon, it said in a statement on Monday.

Conventional antibodies, such as Cosentyx, are made up of two immunoglobulin heavy chains and two light chains, with variable heavy and light domains that together give antibodies their ability to target specific pathogens. Nanobodies or single-domain antibodies, which are found naturally in llamas and other camelids, need only a single variable domain to recognize its target.

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With nanobodies, MoonLake hopes to deliver the targeting ability of conventional antibodies with the advantages of an antibody fragment, including easier manufacturing and high thermostability, or better stability in high temperatures.

Founded earlier this year, MoonLake launched with an undisclosed series A from BVF Partners. Under the sonelokimab deal, Merck KGaA will receive an upfront payment and equity in MoonLake, as well as development and commercial milestone payments down the line.