First Patients Enrolled in Phase 2 Proof of Concept Trial of MC2-25 VLS in Vulvar Lichen Sclerosus
MC2-25 VLS is a based on a di-peptide that inhibits carbamylation of amino acids and proteins in skin.
The first patients have been enrolled in a Phase 2a proof of concept trial evaluating the safety and efficacy of MC2-25 VLS, a new drug candidate for the treatment of urea- associated skin diseases, including vulvar lichen sclerosus.
MC2-25 VLS is a based on a di-peptide that inhibits carbamylation of amino acids and proteins in skin. MC2-25 VLS developer MC2 Therapeutics believes that carbamylation of amino acids and proteins in the vulvar region by iso-cyanate is the root cause of vulvar lichen sclerosus.
MC2-25 VLS may provide relief from the severe itch, erosions, fissures and pain associated with this condition.
The Phase 2 clinical trial is being conducted at multiple centres across Denmark and will evaluate the safety and efficacy of MC2-25 VLS in patients with vulvar lichen sclerosus. Forty patients will be recruited for the study and randomized 1:1 in a double-blinded, placebo-controlled parallel-group trial to 12 weeks topical treatment with MC2-25 VLS or placebo.
The data generated from this trial will inform the trial design for a larger Phase 2b trial.
“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,” says Professor Lars Iversen, CMO of MC2 Therapeutics, in a news release. “As pioneers in uremic diseases, this trial represents a major step forward for MC2 in developing a safe and effective treatment for vulvar lichen sclerosus that severely affects the quality of life of millions of women globally.”
Jesper J. Lange, CEO of MC2 Therapeutics adds: “We are proud to be pioneering MC2-25 VLS for the treatment of vulvar lichen sclerosus as well as for the treatment of Chronic Kidney Disease-associated pruritus in an ongoing Phase 2 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.”