MC2 Therapeutics Commences Patient Enrolment To Treat Skin Disease

MC2 Therapeutics announced the enrollment of the first patients in a phase 2 proof-of-concept trial evaluating the safety and efficacy of MC2-25 VLS, an innovative new drug candidate for the treatment of urea-associated skin diseases, including Vulvar Lichen Sclerosus (VLS), for which no approved treatment options exist.

MC2-25 VLS is a novel treatment paradigm based on a di-peptide that inhibits carbamylation of amino acids and proteins in skin. MC2 Therapeutics believes that carbamylation of amino acids and proteins in the vulvar region by iso-cyanate is the root cause of VLS. MC2-25 VLS has the potential to provide relief from the severe itch, erosions, fissures and pain associated with VLS. This debilitating inflammatory condition is thought to affect millions of patients globally and studies have shown that ~3% of women with VLS eventually develop vulvar squamous cell carcinoma, as per pharmabiz.

The phase 2 clinical research, which is being undertaken across Denmark, will assess the safety and effectiveness of MC2-25 VLS in individuals with VLS. In a double-blind, placebo-controlled parallel-group experiment, 40 patients will be randomized 1:1 to receive 12 weeks of topical therapy with MC2-25 VLS or placebo.  

“MC2-25 VLS has been developed based on our novel treatment paradigm targeting carbamylation in the skin and the active di-peptide component is formulated using our proprietary PAD Technology. This delivers a highly attractive treatment profile based on ease of use and tolerability in sensitive, fissured skin,” said Professor Lars Iversen, CMO of MC2 Therapeutics. “As pioneers in uremic diseases, this trial represents a major step forward for MC2 in developing a safe and effective treatment for VLS that severely affects the quality of life of millions of women globally."