MC2 Therapeutics has completed enrolment in its Phase II MC2-25 Ph2 chronic kidney disease-associated pruritus trial, with topline results expected in Q2 2024.
MC2-25 CKD is a first-in-class drug candidate and could represent a potential breakthrough in the understanding and treatment of urea associated skin diseases.
Chronic kidney disease-associated pruritus (CKD-aP) is a debilitating condition thought to affect a significant proportion of the ~800 million people globally who suffer from CKD stages 3-5.
MC2-25 CKD is based on a di-peptide selected to inhibit carbamylation of amino acids and proteins in skin, which is believed to be the causal factor in CKD-aP.
Kieran McCafferty, Barts Health NHS Trust and Senior Lecturer at Queen Mary University London and principal investigator of the trial, said: “CKD-aP is a frequent, and highly debilitating symptom of many patients with advanced CKD, a progressive condition which affects around 10% of the general population. This new understanding of the role played by carbamylation in CKD-aP is very exciting and offers hope to millions of patients.”
The active component of MC2-25 CKD is a di-peptide, which is formulated in cream based on MC2 Therapeutics’ formulation and drug delivery system PAD Technology. It is an effective isocyanate scavenger, showing >90 % inhibition of protein carbamylation and counteracts the morphological skin changes induced by carbamylation.
Jesper Lange, CEO of MC2 Therapeutics, added: “We are pioneering new ground in this important field and strongly believe that MC2-25 CKD has the potential to finally bring meaningful change to the millions of CKD patients who suffer from debilitating itch and dryness of their skin. We look forward to the data next year and to completing our discussions with regulatory authorities to fast track this treatment to patients globally.”