MC2 Therapeutics has enrolled the first patients in a Phase II proof of concept (PoC) trial assessing the new drug candidate, MC2-25 VLS, to treat urea-associated skin diseases, including vulvar lichen sclerosus (VLS), a chronic, inflammatory, cutaneous disorder.
MC2-25 VLS is a new treatment paradigm based on a di-peptide, which blocks the carbamylation of proteins and amino acids in the skin.
The new drug candidate holds the potential to provide relief from the severe itch, fissures, erosions and pain associated with VLS.
This clinical study is being carried out at several centres across Denmark. It will assess the efficacy and safety of MC2-25 VLS to treat patients with VLS.
MC2 Therapeutics will recruit 40 patients for the double-blinded, placebo-controlled, parallel-group trial and randomise them into a 1:1 ratio to receive 12 weeks of topical treatment with the drug or placebo.
The study’s primary objective is to assess the therapy’s efficacy against the MC2-25 VLS vehicle in VLS.
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Exploring the safety of the drug versus MC2-25 VLS vehicle in VLS and the burden of VLS on women’s lives are the secondary objectives.
Furthermore, findings from the Phase IIa PoC study will be utilised for planning a larger Phase IIb trial.
MC2 Therapeutics CEO Jesper Lange said: “We are proud to be pioneering MC2-25 VLS for the treatment of VLS as well as for the treatment of chronic kidney disease-associated Pruritus in an ongoing Phase II trial.
“In both cases we have the potential to radically change the treatment paradigm for these major indications with huge patient populations, further demonstrating our commitment to changing the immunology and inflammation landscape.”
In September 2022, MC2 Therapeutics dosed the first subjects in a Phase II study of its drug candidate, MC2-25 Cream, to treat moderate to severe chronic kidney disease-associated pruritus (CKD-aP) in stage 3-5 CKD patients.