Life science company Recardio is set to continue the Phase II clinical trial of its dutogliptin drug in combination with filgrastim in severe heart attack patients.
The drug combination is being evaluated for the ability to restore lost myocardial function in patients who had stent placement via percutaneous coronary intervention.
Following an interim analysis of the trial, a Data Safety Monitoring Board recommended that the randomised, double-blind, placebo-controlled study can continue without any changes. This will enable participating trial sites to continue patient enrolment.
Recardio executive chairman Roman Schenk said: “The interim analysis was a critical milestone to completion of the study. We are encouraged by the efforts of the clinical investigators and look forward to the conclusion of the trial by this year.”
Dutogliptin is designed as a regenerative medicine to reduce and repair heart muscle injury. It acts as an inhibitor of dipeptidylpeptidase-IV (DPP4) enzyme, which is involved in the degradation of stromal-derived factor-1α (SDF-1α).
The Phase II trial is assessing a 60mg, twice-a-day, subcutaneous injection of dutogliptin for 14 days combined with 10µg/kg, daily, subcutaneous dose of filgrastim for five days. It is set to enrol a total of 120 patients.
The primary endpoint of the study is safety and tolerability of the combination when compared to placebo in adults with ST-elevation myocardial infarction (STEMI).
Meanwhile, the trial’s secondary objectives include preliminary efficacy of dutogliptin plus filgrastim, along with pharmacokinetics and pharmacodynamics of dutogliptin in a study subset.
The study will also assess exploratory endpoints of the combination’s effects on plasma stromal cell-derived factor (SDF)-1a levels and plasma biomarkers.
Initiated in 2018, the Phase II trial is expected to be completed in October this year.