MC2 Therapeutics has dosed the first subjects in a Phase II clinical trial of its drug candidate, MC2-25 Cream, for the treatment of moderate to severe chronic kidney disease-associated pruritus (CKD-aP) in stage 3-5 CKD patients.
Named MC2-25-C1, the multicentre, randomised, double-blind, parallel-group trial will analyse the efficacy and safety of MC2-25 Cream versus an MC2-25 vehicle.
The company intends to enrol nearly 108 subjects at 23 European centres.
In the trial, subjects will apply the cream topically twice a day for 12 weeks.
Comparing MC2-25 Cream’s therapeutic efficacy to a vehicle cream and characterising its safety profile in subjects are the trial’s primary objectives.
The mean variation from baseline in the weekly mean Worst Itch Numeric Rating Score (WI-NRS) to week 12 is the primary efficacy endpoint of the trial.
Treatment success as per the responder endpoints, as well as other outcomes reported by the subjects and physician, will be the trial’s secondary endpoints.
Topline data from this trial is anticipated in the first quarter of 2024.
An isocyanate scavenger, MC2-25 Cream has a di-peptide as its active component.
In an in vitro reconstructed human uremic skin model, the drug was found to hinder more than 90% of protein carbamylation and counteract the carbamylation-elicited morphological skin changes.
MC2 Therapeutics president and CEO Jesper Lange said: “The initiation of the Phase II trial with MC2-25 Cream in Europe marks the first step in our journey to leverage our scientific breakthrough discovery of how to treat urea associated skin diseases, for which there are currently limited or no approved therapies.
“As part of our commitment to developing this novel treatment paradigm, we also plan to engage with regulatory authorities in the US in Q4 2022 as part of our global CKD-aP programme.”
In August 2019, the company concluded enrolment in a Phase III trial of MC2-01 PAD Cream to treat plaque psoriasis in adults.