Periodic Reporting for period 1 - CardioProtectMI (A New Drug Therapy for the treatment of ST Elevated Myocardial Infarction)
Reporting period: 2019-11-01 to 2020-02-29
Patients suffering a heart attack will be admitted to hospital with chest pain, caused by occlusion of a coronary vessel and leading to myocardial ischaemia. The diagnosis of the patient into one of three sub-types of myocardial infarction (MI) defines the acute treatment option. Reperfusion therapy is standard therapy in patients where the sub-type of ST-elevation MI (STEMI) is confirmed by electrocardiogram (ECG) recording showing an ST-segment elevation. In contrast, patients without ST elevation at presentation are designated non-ST-elevation MI (NSTEMI). The categories of patients with STEMI, NSTEMI, or unstable angina are customarily included in the concept of Acute Coronary Syndromes (ACS).
During myocardial infarction the tissues of the myocardium become ischaemic. The section of myocardial tissue that succumbs to necrosis due to prolonged ischaemia is referred to as an infarct. An MI will eventually be converted to scar tissue, which is incapable of muscular contraction, in a process called fibrosis. Thus, MI and the subsequent fibrosis lessen the pumping ability of the heart and can lead to post-MI co-morbidities such as chronic heart failure (HF) and arrhythmias. STEMI typically occurs when the MI is large, whereas NSTEMI are minor and with good prognosis.
Current treatment of STEMI leads to a significant challenge in that reinstating blood flow to the heart by removal of the occlusion leads to further damage to cardiac tissue; this is termed Reperfusion Injury (RI) and further increases the size of the infarction. The greater the RI the more likely the individual is to develop heart failure and/or suffer early death.
Currently there is no treatment to protect against RI. ResoTher Pharma ApS (ResoTher) is developing RTP-026, a novel peptide drug, as an add-on therapy for the treatment of STEMI that will reduce the amount of RI thus improving the prognosis of the patient.
The SMEi Ph1 has allowed ResoTher to further assess the business and clinical strategies for RTP-026:
The identification and collaboration with Key Opinion Leaders and Contract Research Organisations experienced in the development and execution of early clinical development trials (Phases I and IIa to proof of concept).
Evolving the clinical development plan to ensure the success and timely execution of the early clinical trials through discussion with the above individuals and organisations. This has lead to refining the patient selection criteria and selection of surrogate (biomarker/MRI) endpoints in order to position the drug in the most likely responder population.
Refine the business plan and positioning of RTP-026 after building a competitive market map of STEMI treatment.
During myocardial infarction the tissues of the myocardium become ischaemic. The section of myocardial tissue that succumbs to necrosis due to prolonged ischaemia is referred to as an infarct. An MI will eventually be converted to scar tissue, which is incapable of muscular contraction, in a process called fibrosis. Thus, MI and the subsequent fibrosis lessen the pumping ability of the heart and can lead to post-MI co-morbidities such as chronic heart failure (HF) and arrhythmias. STEMI typically occurs when the MI is large, whereas NSTEMI are minor and with good prognosis.
Current treatment of STEMI leads to a significant challenge in that reinstating blood flow to the heart by removal of the occlusion leads to further damage to cardiac tissue; this is termed Reperfusion Injury (RI) and further increases the size of the infarction. The greater the RI the more likely the individual is to develop heart failure and/or suffer early death.
Currently there is no treatment to protect against RI. ResoTher Pharma ApS (ResoTher) is developing RTP-026, a novel peptide drug, as an add-on therapy for the treatment of STEMI that will reduce the amount of RI thus improving the prognosis of the patient.
The SMEi Ph1 has allowed ResoTher to further assess the business and clinical strategies for RTP-026:
The identification and collaboration with Key Opinion Leaders and Contract Research Organisations experienced in the development and execution of early clinical development trials (Phases I and IIa to proof of concept).
Evolving the clinical development plan to ensure the success and timely execution of the early clinical trials through discussion with the above individuals and organisations. This has lead to refining the patient selection criteria and selection of surrogate (biomarker/MRI) endpoints in order to position the drug in the most likely responder population.
Refine the business plan and positioning of RTP-026 after building a competitive market map of STEMI treatment.
The Horizon 2020 SMEi I has allowed ResoTher to further develop the feasibility of both their clinical and business strategies.
This work was conducted within three interlinked work packages over a period of 4 months as outlined in the grant proposal.
The high level objectives and outputs of these work packages were:
- Evolve the clinical development plan to ensure best chance of success for the candidate drug.
- Identify and select key clinical collaborators
- further develop a competitive market map of STEMI treatment.
Outputs from these work packages validates the continued development for the candidate drug.
This work was conducted within three interlinked work packages over a period of 4 months as outlined in the grant proposal.
The high level objectives and outputs of these work packages were:
- Evolve the clinical development plan to ensure best chance of success for the candidate drug.
- Identify and select key clinical collaborators
- further develop a competitive market map of STEMI treatment.
Outputs from these work packages validates the continued development for the candidate drug.
Current treatment of STEMI leads to a significant challenge in that reinstating blood flow to the heart by removal of the occlusion leads to further damage to cardiac tissue; this is termed Reperfusion Injury (RI) and further increases the size of the infarction (damage). The greater the RI the more likely the individual is to develop heart failure and/or suffer early death.
Currently there is no treatment to protect against RI. ResoTher Pharma ApS (ResoTher) is developing RTP-026, a novel peptide drug, as an add-on therapy for the treatment of STEMI that will reduce the amount of RI thus improving the prognosis of the patient. Successful development of a drug to treat RI will be of great benefit to patients suffering STEMI and also provide a cost-benefit to health care systems. This project will allow for the further development of RTP-026 toward clinical utility.
Currently there is no treatment to protect against RI. ResoTher Pharma ApS (ResoTher) is developing RTP-026, a novel peptide drug, as an add-on therapy for the treatment of STEMI that will reduce the amount of RI thus improving the prognosis of the patient. Successful development of a drug to treat RI will be of great benefit to patients suffering STEMI and also provide a cost-benefit to health care systems. This project will allow for the further development of RTP-026 toward clinical utility.