Research history
The history of research on the SYN2 cardiotracer
The history of research on the cardiotracer SYN2 began in 2013 with the analysis of compounds in terms of their physical and pharmacokinetic properties and their potential for use in myocardial perfusion imaging. On the basis of the studies conducted, a compound was selected labelled with fluorine-18, an isotope with a favourable half-life enabling both high-quality imaging and distribution of the radiopharmaceutical to numerous diagnostic centres.
In 2015 the project obtained co-funding from Poland’s National Centre for Research and Development (NCBiR), which enabled further development of the project and transition to the next stages of research.
Preclinical trials
The foundation for safety and selectivity
In the preclinical phase, a broad range of pharmacological and toxicological studies were conducted, including assessment of:
- The stability of the compound,
- Uptake by the heart muscle,
- The safety profile,
- Pharmacokinetic parameters.
The results confirmed the high selectivity and favourable safety profile of SYN2, enabling the transition to clinical trials.
Clinical trials
Safety, efficacy, diagnostic value
The clinical trials have been carried out in phases.
The adaptive methodology involves setting the number of patients for each stage of the trial. After completion of a stage, the interim data are analysed to assess whether the previously established criteria for efficacy or safety have been met:
- If the results are positive, the trial may be completed earlier
- If not, it is possible to expand the number of patients, or make modifications consistent with the previously approved adaptive rules.
The main aim of phase III is to assess the diagnostic efficacy of SYN2 compared to reference angiographic methods, such as invasive coronary angiography (ICA), fractional flow reserve (FFR) or instantaneous wave-free ratio (iwFR).
An additional element of the trial is a quantitative assessment of coronary flow, which may prove to be a breakthrough in non-invasive diagnosis of coronary artery disease.
The trials are conducted at multiple centres in Europe, e.g. in Poland, Finland, the Netherlands, Germany and Italy, as well as the United States.
Conducting phase III clinical trials in the United States requires organization of local production, preceded by technology transfer involving, among other things, supply of:
- Synthesis modules
- Full documentation of the method of producing the radiopharmaceutical
- Detailed quality assurance procedures.
This process is covered by contracts for protection of intellectual property and is one of the key elements impacting the timetable for completion of clinical trials.
Expert support and scientific standing of SYN2
The SYN2 is backed by an international council of experts, increasing its scientific reliability and registration potential. To date, the research results have been presented at some of the most important industry conferences, and scientific publications have appeared in renowned journals, including:
- The Journal of Nuclear Medicine,
- EJNMMI Research (European Journal of Nuclear Medicine and Molecular Imaging Research).
The research results concerning SYN2 have been discussed at key scientific events, such as:
- Annual congresses of the European Association of Nuclear Medicine (EANM) in 2023–2025,
- The ASNC Annual Scientific Session & Exhibition conference in Orlando,
- The International Conference on Nuclear Cardiology and Cardiac CT (ICNC-CT) in 2024 in Seville.
Patent protection
SYN2 is covered by patent protection in Poland, Europe and Japan, and patent registration in the United States is underway. This further strengthens the product’s position on the global market.