CLINICAL PROGRAM
ACUTE MYOCARDIAL INFARCTION
PHASE 3 PIVOTAL STUDY IN AMI (HEAL-AMI)
HEAL-MI is a global multicenter, randomized, double-blind, placebo-controlled Phase 3 trial that evaluates safety and efficacy of Dutogliptin in co-administration with Filgrastim in Early Recovery Post-Myocardial Infarction.
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Status of Study
The study design was already approved by FDA and EMA, the study is in preparation and patient enrollment in global clinical sites is intended starting in 2025.
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Study Design
Based on the completed and promising Phase 2 study results, HEAL-MI will evaluate the safety and efficacy of dutogliptin administered sc in co-administration with filgrastim in adult patients undergoing PCI. In order to observe primary outcome events in patients in this event-driven trial, patients will be randomized in a 1:1 ration to self-administer SC injections of dutogliptin for 14 days in co-administration with filgrastim for 5 days or matching dutogliptin and filgrastim placebo accordingly. heart. The study was seeking primarily to determine safety and the capacity to improve heart function using cardiac MRI for evaluation.
The study is designed as a double-blind, randomized, placebo-controlled trial (Phase 3).
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Patient Population
Patients to be enrolled in this study are having an acute myocardial infarction (STEMI) verified by electrocardiogram (ECG) and have received local standard of care procedures including (PCI). Treatment will be initiated after completion of the PCI procedure, but not later than 12 hours thereafter.
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For more information about this clinical study, visit the following link:
https://www.clinicaltrials.gov/study/NCT05881382?cond=NCT05881382
PHASE 2B STUDY IN AMI (REC-DUT-002)
REC-DUT-002 was a global multicenter, double-blind, randomized, placebo-controlled trial that evaluated the safety and initial efficacy of dutogliptin in co-administration with filgrastim as an adjunct treatment for patients in early recovery following an Acute Myocardial Infarction (AMI).
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Status of Study
Patient enrollment was completed in January 2021 and the study was closed out early in the second quarter of 2021.
Study Design
Based on the pre-clinical determination of efficacy, the establishment of safety, tolerability, and pharmacokinetics of dutogliptin in healthy subjects, and the extensive clinical experience with G-CSF (filgrastim) for stem cell mobilization, the study evaluated dutogliptin in co-administration with filgrastim in patients who had an AMI and received successful initial treatment with PCI and stent placement. Filgrastim is used to mobilize stem cells from the bone marrow to circulating blood while dutogliptin activates stem cell migration and homing from blood to the site of ischemia or injury in the heart. The study was seeking primarily to determine safety and the capacity to improve heart function using cardiac MRI for evaluation.
The study was designed as a double-blind, randomized, placebo-controlled trial (Phase 2B).
Patient Population
Patients who participated in this study were those who had a large myocardial infarction (STEMI) due to coronary artery atherosclerotic disease where treatment could be initiated within 36 hours of the STEMI. Specific eligibility criteria are listed in the link below. After completion of screening procedures, patients were randomized to receive either dutogliptin in combination with G-CSF or placebo.
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For more information about this clinical study, visit the following link:
https://clinicaltrials.gov/ct2/show/NCT03486080?term=Recardio&rank=2
PHASE 1 STUDY
The Phase 1 study of dutogliptin evaluated safety, pharmacokinetics and pharmacodynamics in healthy volunteers after single and repeated parenteral application.
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Status of Study
Enrolment completed in September 2017 at the University Hospital of Vienna, Austria.
Study Rationale and Design
While dutogliptin has an excellent and well-known safety profile because it was initially developed to treat diabetes, this study evaluated a new form of administration. Specifically, healthy volunteers received single and repeated parenteral applications to understand dutogliptin’s safety, pharmacokinetics and pharmacodynamics. To that end, the study was designed with nine cohorts as an open-label, single center study.
Patient Population
Healthy volunteers.
Outcomes
The study confirmed the acceptable safety and tolerability profile of dutogliptin with volunteers reporting only mild to moderate discomfort primarily related to the actual injections. The study also established the dosage and the dosing schedule for a future clinical study.
CONGESTIVE HEART FAILURE
PHASE 2B STUDY IN CHF (REC-DUT-004)
The planned global multicenter, randomized, double blind, placebo controlled, parallel group study will evaluate the benefit of dutogliptin in combination with G-CSF as an adjunct treatment for patients with Heart Failure and reduced Ejection Fraction (HFrEF).
Status of Study
Planned to start in 2025.
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Study Design
The double-blind, randomized, placebo-controlled study (Phase 2B) will evaluate both safety and efficacy of dutogliptin in combination with G-CSF as an adjunct treatment for patients with Heart Failure and reduced Ejection Fraction (HFrEF) of <40%. Patients will be in disease stage NYHA Class II and III (mild to marked symptoms and limitation during ordinary activity.