ResoTher Pharma is pleased to announce that the first patient has been dosed in the Phase 2a clinical trial of its novel drug candidate, RTP-026, in patients suffering from myocardial infarction (MI), commonly known as a heart attack. This significant milestone underscores ResoTher Pharma’s commitment to develop groundbreaking treatments for cardiovascular diseases.
The Phase 2a trial is an exploratory, randomized, double-blind, multicentre, placebo-controlled trial designed to assess the safety, tolerability, and efficacy of RTP-026 in patients with ST-Elevation Myocardial Infarction (STEMI). This study employs an enrichment design to identify a subset of high-risk STEMI patients. The trial will be conducted at multiple sites in Denmark and the UK, and aims to enrol 96 patients, who will be randomly assigned to receive either RTP-026 or placebo in a 3:1 ratio. The main purpose of the trial is to evaluate the safety and tolerability of RTP-026 compared to placebo. Additionally, the study will assess the efficacy of RTP-026 by monitoring changes in cardiac biomarkers and measuring initial and 90-day cardiac parameters, such as infarct size and myocardial salvage index, using cardiac MRI.
Despite medical advancements, MI remains a significant global health concern. Primary Percutaneous Coronary Intervention (PCI) is the standard treatment for MI patients. However, this coronary reperfusion strategy can lead to hyperinflammation which plays a crucial role in determining the infarct size and contributes to adverse post-heart attack left ventricular remodelling, increasing the risk of chronic heart disease or mortality. ResoTher Pharma is fully committed to addressing this important medical challenge through innovative research and development efforts.
About RTP-026
RTP-026 is derived from the endogenous human protein Annexin A1, which has been demonstrated to promote resolution of inflammation and tissue protection in various disease models. RTP-026 mimics Annexin A1 and acts through G-protein coupled receptors expressed on immune cells. Pre-clinical data have demonstrated that RTP-026 restores cardiac function post MI through regulation of neutrophil and monocyte recruitment. Furthermore, RTP-026 promotes neutrophil apoptosis, enhances efferocytosis, and shifts macrophage phenotype towards a pro-resolving phenotype. These orchestrated cellular events collectively contribute to resolution of inflammation and tissue healing.
RTP-026 has shown an excellent safety profile in a Phase I, double-blind, placebo-controlled trial in healthy male volunteers and post-menopausal women.
About ResoTher pharma
ResoTher Pharma is a clinical-stage biotech company based in Copenhagen, Denmark, dedicated to providing innovative and effective treatment options for patients suffering from inflammatory-driven diseases. Our mission is to transform the standard of care with a robust pipeline of drug candidates, ultimately improving the lives of patients worldwide.
For more information, please visit ResoTher Pharma or contact:
Anders Kronborg, CEO
Email: akr@resotherpharma.com
