SPARC study achieved all its objectives, establishing a strong clinical foundation for a differentiated, non-glucose-based treatment for peritoneal dialysis

• Positive Phase 1 results strengthen confidence in OPT101, with SPARC achieving its objectives across all major endpoints, including safety, tolerability, pharmacokinetics and functional activity in patients with moderate/severe chronic kidney disease.
• Fluid and sodium removal across short and long dwells reinforces the differentiated potential of OPT101 as a novel non-glucose-based approach to peritoneal dialysis.
• Clinical evidence in patients with moderate/severe chronic kidney disease supports advancement of OPT101 to Phase 2a.
   

MUTTENZ, Switzerland, Sept. 22, 2026 (GLOBE NEWSWIRE) -- Opterion Health AG, a Swiss clinical-stage biotechnology company developing a novel non-glucose-based solution for peritoneal dialysis, today announced positive results from SPARC, its first-in-human Phase 1 clinical study of OPT101.

SPARC evaluated different concentrations of OPT101 in four-hour and eight-hour dwells, in patients with moderate/severe chronic kidney disease. No serious adverse events, treatment discontinuations due to adverse events, dose interruptions, concentration-limiting toxicities or interruptions to dose escalation were reported. OPT101 demonstrated compelling activity across all evaluated concentrations. The highest concentration produced the greatest mean fluid removal in both short and long dwells, accompanied by sodium removal.

The findings support advancement to Phase 2a, which is expected to evaluate repeated administration, dose selection, broader dwell replacement, and OPT101’s functional and metabolic differentiation in chronic kidney disease patients.

“This marks an important value inflection point for our company,” said Peter Reinemer, Chief Executive Officer of Opterion Health AG. “OPT101 has progressed from scientific promise to encouraging clinical evidence in patients. SPARC strengthens our confidence in the program and creates meaningful momentum in a very large therapeutic field that has seen limited innovation for more than three decades.”

“SPARC was a very positive first clinical experience with OPT101, and patients responded well,” said Aivars Pētersons, Principal Investigator of the SPARC study. “Peritoneal dialysis offers patients greater independence, but current solutions still involve important limitations. A flexible, non-glucose-based option for both short and long dwells could address a clear unmet need and be a welcome innovation.”

Peritoneal dialysis allows people with kidney failure to receive life-sustaining treatment at home, yet patients still rely heavily on glucose-based solutions that can contribute to metabolic complications, weight gain, and damage to the peritoneal membrane over time. Existing non-glucose alternatives cannot cover both short and long dwells limiting treatment choice and adding complexity to an already demanding daily routine.

OPT101 is being developed as a differentiated, non-glucose-based solution for both short and long dwells. No currently available solution offers the same intended combination of non-glucose-based treatment, concentration flexibility and use across both dwell settings.

“SPARC delivered the results we needed and provides a strong foundation for OPT101’s next stage of development,” said Maxim Voropaiev, Chief Medical Officer of Opterion Health AG. “The Phase 2a GLOW trial is expected to evaluate repeated use, optimize dose selection and assess OPT101 across more of the daily dialysis regimen, bringing us closer to demonstrating its functional and metabolic differentiation in this patient population.”

About OPT101

OPT101 is the investigational, non-glucose-based osmotic driver solution of Opterion Health AG designed to expand treatment choice across short and long peritoneal dialysis dwells. Phase 1 SPARC results demonstrated a favorable safety and tolerability profile as well as encouraging exploratory evidence of fluid and sodium removal in patients with moderate/severe chronic kidney disease.

About Opterion Health AG

Opterion Health AG is a Swiss clinical-stage biotechnology company advancing a novel, non-glucose-based approach to peritoneal dialysis (PD) suitable for both short and long dwell use. Its lead program, OPT101, has successfully completed Phase 1 clinical evaluation and is being developed to address longstanding limitations of conventional PD therapy, with the goal of expanding treatment choice and enabling more patients to benefit from home-based dialysis.

Despite offering important clinical and lifestyle advantages, PD accounts for only around 12% of dialysis patients globally. As rising rates of chronic kidney disease and diabetes increase pressure on healthcare systems, the global PD market is estimated to be worth approximately USD 11.5 billion in 2025 and is projected to reach USD 21.5 billion by 2034, representing a compound annual growth rate of approximately 7.2%.

Opterion Health AG is led by a highly experienced team in global dialysis, bringing together decades of expertise across renal care, clinical development, commercialization and healthcare operations.

For further information, please contact:

info@opterion.com
www.opterion.com