NP202 for Treatment of Post -STEMI Left Ventricular Systolic Dysfunction

Study Overview
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Brief Summary
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NP202 is an experimental drug being developed by Armaron Bio Pty Ltd for potential use as a treatment for people after they have had a heart attack (MI).

Detailed Description
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After someone has a MI, their heart 'remodels', which means that it changes in size and shape. This damage can lead to it being weaker and less efficient, and ultimately to major heart problems. There are some drugs currently available which help prevent remodelling and are used for treatment post-MI. However, there is still a high rate of remodelling and major heart problems in people post-MI. NP202 works in a different way to the drugs that are currently approved, and has been shown in animal studies to prevent post-MI remodelling. This study will assess NP202 versus placebo on remodelling over a 3 month treatment period, with 1 month follow up

Official Title
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A Phase II Randomised, Double-Blind, Placebo-Controlled Study of the Efficacy, Safety and Tolerability of Oral NP202 in Adults Who Have Left Ventricular Systolic Dysfunction Following Myocardial Infarction

Conditions
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ST Elevation Myocardial Infarction

Intervention / Treatment
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* Drug: NP202
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Have had a confirmed ST elevation myocardial infarction (STEMI) in the previous 5 days, which met all of the following criteria; ≥ 0.2mV ST elevation in 2 or more V1 - V6 leads with presentation in a maximum of 12 hours of onset of symptoms Troponin levels >10 x upper limit of normal (ULN) at the site's local laboratory. Successful revascularisation by Percutaneous Coronary Intervention (PCI) Have left ventricular dysfunction post STEMI as evidenced by left ventricular ejection fraction (LVEF) ≤40% confirmed by echocardiogram at screening. Are receiving guideline-directed medical therapy for acute MI and post-MI left ventricular (LV) dysfunction according to national cardiology society/heart association STEMI guidelines. Exclusion Criteria: Known cardiomyopathy or heart failure prior to MI. Cardiogenic shock and/or systolic blood pressure <85mmHg at Screening. Clinical history of ejection fraction ≤40% prior to this MI, or multiple prior MIs. Daily use of non-steroidal anti-inflammatory drugs (NSAIDs) and/or cyclooxygenase-2 (COX-2) inhibitors in the past month. Presence of device/hardware incompatible with MRI Estimated glomerular filtration rate (eGFR) <30ml/min Liver function tests 3 x ULN due to non-cardiac disease Have received any investigational research agent within 30 days or 5 half-lives (whichever is longer) prior to the first dose of investigational product.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NP202<br>1000mg oral NP202 daily for 90 days | Drug: NP202<br>* Active<br>|
| Placebo Comparator: Placebo<br>Oral placebo daily for 90 days | Other: Placebo<br>* Placebo<br>* Other names: Microcellulose;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy as measured by Change from baseline in left ventricular end systolic volume index (LVESVi) | Change from baseline in left ventricular end systolic volume index (LVESVi) as assessed by MRI at 3 months | From baseline to 3 months post MI | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy as measured by Change from baseline in LV end diastolic volume index (LVEDVi) | Change from baseline in LV end diastolic volume index (LVEDVi) as assessed by MRI at 3 months. | From baseline to 3 months post MI | 
| Efficacy as measured by Change from baseline in LV ejection fraction (LVEF) | Change from baseline in LVEF as assessed by MRI at 3 months. | From baseline to 3 months post MI | 
| Efficacy as measured by Change from baseline in LV diastolic function | Changes from baseline in LV diastolic function based on LV peak filling rate as assessed by MRI at 3 months. | From baseline to 3 months post MI | 
| Efficacy as measured by Change from baseline in relative infarct size | Change from baseline in relative infarct size as a percent of LV mass as assessed by late contrast enhancement MRI at 3 months. | From baseline to 3 months post MI |