in Recent Years
Dialysis is a lifesaving treatment, but also exerts adverse effects on different organs, such as the cardiovascular system.
Peritoneal Dialysis has better survival outcome during the first 3 to 5 years, but this therapy is limited in time, due to peritoneal fibrosis. Therefore, the WHO and Western health authorities recommend starting dialysis treatment with PD and switching to HD as peritoneal ultrafiltration efficacy attenuates.
Opterion applies different strategies to reduce different side effects of PD:
- Reducing osmotic pressure during PD dwells without compromising ultrafiltration efficacy.
- Eliminating glucose from PD solutions to avoid metabolic syndrome.
- Decrease cytotoxicity of PD solutions to the peritoneum, reducing fibrosis, with the goal to prolong PD treatment time.
- Clinical studies will show whether the Opterion PD solution may also reduce systemic inflammation.
Osmotic Driver (ODR):
- Opterion develops a new osmotic driver for PD (Opt100), composed of short glucose polymers (~5kDa) and maltose. Opt100 can be applied for short and long dwells1. Different Opt100 concentrations allow to adapt Ultrafiltration efficacy, comparable to glucose-based PD solutions. But Opt100 contains less than 0.1% glucose1, thereby representing less or no metabolic challenge as compared to current PD treatments.
- Opt100 is the first osmotic driver allowing all dwells of a PD patient to be run by a glucose free PD solution (reduced metabolic challenge).
- All ODR components have previously been applied in humans at very comparable concentrations with no tolerability issues.
- Opt100 manufacturing and toxicology studies to be established in 2020/21.
- Manufacturing partners for preclinical and clinical trials supply engaged.
1 Grentzmann & Steinhauer 2018, WO2018146345 (A1)
Biocompatibility-enhancing Agent (BCA):
- Cell-culture of primary human peritoneal mesothelial cells show decreased cytotoxicity of PD-solutions in presence of different stilbenoids, including Resveratrol2.
- Resveratrol reduces vascular endothelial growth factor (VEGF) in a rat PD model2.
- Stilbenoids are solubilized and stabilized by saccharide containing solutions such as Opt1003.
- Resveratrol is an established food additive and has GRAS* status in the USA.
- 2 Grentzmann 2017, WO2017013120 (A1)
3 Grentzmann 2017, WO2017013121 (A1)
* GRAS: generally recognized as safe