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Examining the results of MEX0114, a phase 2 trial evaluating the use of ladarixin in patients with new-onset type 1 diabetes.
Results of a phase 2 trial examining a CXCR1/2 inhibitor in adult patients with new-onset type 1 diabetes is shining new light on the potential of the ladarixin in treatment of diabetic diseases.
While the trial failed to meet its primary endpoint at 13 weeks, which was to examine if ladarixin had sufficient activity to preserve β-cell function in new-onset type 1 diabetes, results indicated ladarixin provided benefit in certain subgroups of patients and investigators feel results of the multicenter phase 2 study offer valuable insight into the potential of ladarixin.
Presented at the American Diabetes Association’s (ADA) 80th Scientific Sessions, MEX0114 was a multicenter, randomized, double-blind, placebo-controlled phase 2 study examining the CXCR1/2 inhibitor in a population of 76 patients. Those included in the study were randomized in a 2:1 ratio to 400 mg ladarixin twice-daily or placebo—in total, 50 patients were randomized to ladarixin and 26 were randomized to placebo.
Per trial design, patients received 3 treatment cycles consistent, each consisting of 14 days on and 14 days off the randomized treatment. Patients were then followed for 12 months.
Upon analysis, results indicated no statistically significant differences in mixed meal tolerance test (MMTT) area under the curve (AUC) of C-peptide at weeks 13 (P=.330) and 26 (P=.404). However, investigators noted 76.6% of patients receiving ladarixin had an HbA1c below 7% and a daily insulin requirement of less than 0.50 IU/kg compared to just 45.8% of patients receiving placebo (P=.0095).
In a prespecified subgroup analysis of patients with fasting C-peptide below the median value of the trial population at baseline, MMTT AUC of C-peptide trended at week 13 (P=.111) and reached statistical significance at week 26 (P=.041).
Of note, adverse reactions occurring in 10% or more patients during the trial included dyspepsia (16% with ladarixin vs 0% with placebo) and headache (16% with ladarixin versus 15.4% with placebo).
To learn more about the CXCR1/2 inhibitor and future plans to study the agent, HCPLive invited study presenter Paolo Pozzilli, MD, Full Professor of Endocrinology and Diabetes at the University Campus Bio-Medico in Rome, Italy, to take part in a special edition ADA 2020 House Call.
This study, “A Randomized, Double-Blind Phase 2 Trial of the CXCR1/2 Inhibitor Ladarixin in Adult Patients with New-Onset Type 1 Diabetes,” was presented at ADA 2020.