On September 14, MC2 Therapeutics announced that it had completed the first patient dosing of the Phase II MC2-25-C1 trial. The trial was designed to evaluate the safety and efficacy of MC2-25 cream in patients with chronic kidney disease (CKD-aP)-associated moderate to severe pruritus stage III-V.
CKD-aP, also known as uremic pruritus, is a persistent systemic pruritus in which recurrent episodes of moderate-to-severe chronic pruritus severely reduce the patient’s quality of life, can lead to depression, and increase the overall risk of death. In the United States and Europe, CKD-aP affects more than 35 million people, the vast majority (about 30 million) of whom are non-dialysis patients (stages III, IV). Currently used antipruritic regimens such as antihistamines and corticosteroids do not provide sustained, adequate relief. In August 2021, the FDA approved Korsuva for the treatment of moderate-to-severe pruritus associated with chronic kidney disease (CKD-aP) in adults undergoing hemodialysis, the first treatment for pruritus in chronic kidney disease dialysis patients.
MC2-25 cream is a first-in-class drug for the treatment of CKD-aP stage III-V patients. The active ingredient is a dipeptide, which is made by MC2 Therapeutics’ unique PAD technology. It is expected to be the first in the United States and the European Union. Approved drug for the treatment of pruritus associated with stage III-IV chronic kidney disease.
Isocyanates are very reactive molecules that are neurotoxic and readily react with proteins, peptides and amino acids in the body and skin. Carbamylation of amino acids and proteins is highly upregulated in CKD patients and is thought to be a key factor contributing to CKD-ap. MC2-25 cream is an effective isocyanate scavenger that inhibits protein carbamylation by 90% and counteracts carbamylation-induced changes in skin morphology, potentially relieving severe skin dryness and itching in CKD patients .
MC2-25-C1 is a randomized, multicenter, double-blind, parallel-group phase II trial expected to enroll approximately 108 patients with CKD-aP stages 3-5 at approximately 23 centers in Europe for 12-week topical twice-dose / day of treatment. The primary efficacy endpoint of the trial was the change from baseline in Weekly Mean Worst Pruritus Numerical Score (WI-NRS) over 12 weeks.
MC2 Therapeutics said it expects to report top-line results from the clinical trial in the first quarter of 2024.