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Opterion Health AG submits Clinical Trial Application for First-in-Human Study of OPT101 in Patients with Advanced Chronic Kidney Disease

Muttenz, Switzerland – 17 September – Opterion Health AG, a clinical-stage biopharmaceutical company developing OPT101 as an innovative treatment for patients on peritoneal dialysis (PD), today announced the submission of its Clinical Trial Application (CTA) to the European Medicines Agency (EMA). OPT101 is a novel non-glucose-based osmotic agent bringing much-needed new therapy options to patients with renal failure. The development of OPT101 represents the first innovation of its kind in over 30 years in the field of PD.

The CTA submission marks a significant milestone for Opterion in its mission to transform dialysis care and improve the quality of life for patients and their families. The company expects to initiate its first-in-human Phase 1 study, following regulatory approval.

“We are proud to have reached this important step in our development journey,” said Peter Reinemer, Chief Executive Officer of Opterion. “OPT101 has the potential to address long-standing limitations in peritoneal dialysis by eliminating glucose-based osmotic agents, which are associated with metabolic distress and PD complications. We are grateful to our team and partners for their dedication in bringing this innovation closer to patients.”

The Phase 1 SPARC trial will evaluate the safety, tolerability, and pharmacokinetics of OPT101 in patient volunteers. The data will inform future studies in patients with advanced CKD (chronic kidney disease) requiring peritoneal dialysis, a population with limited and often burdensome treatment options.

“The submission of our first-in-human clinical trial application for OPT101 represents a pivotal step forward in our mission to deliver innovative therapies for patients with advanced chronic kidney disease (CKD),” said Maxim Voropaiev, Chief Medical Officer of Opterion. “This Phase I clinical trial reflects our commitment to addressing significant unmet medical need in a growing patient population and we believe OPT101 has the potential to create meaningful clinical and economic value.”

David Ebsworth, Chairman of the Board of Opterion added: “For decades, dialysis patients have faced significant compromises in quality of life and long-term outcomes. OPT101 represents a bold step toward changing that paradigm. We believe that this submission for the SPARC trial is not only a regulatory milestone, but a signal of our commitment to advancing renal care for the PD community globally.”

The CTA submission follows recent strategic developments at Opterion, including the appointment of Rice Powell and Mark Hahn to the Board of Directors, and the expansion of business development activities in Europe, the U.S., and Asia.

About Opterion Health AG

Opterion Health AG is a Swiss-based biopharmaceutical company focused on transforming renal care through the development of novel therapies for peritoneal dialysis patients. Its lead candidate, OPT101, is designed to improve the quality of life of patients undergoing peritoneal dialysis and changing the odds of PD outcomes for those who rely on life-saving treatments.

 

Opterion Health AG, Hofackerstrasse 40, CH-4132 Muttenz, Switzerland

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Jan Anders Karlsson

Board Member
Dr Jan-Anders Karlsson, PhD, has 40 years of experience as a CEO and board member in pharma and biotech companies in Europe, Asia and the US. Jan-Anders was a founder and CEO of Reset Pharmaceuticals Inc, and prior to this served as CEO of Verona Pharma, a NASDAQ-listed biopharmaceutical company developing respiratory drugs. As CEO of S*BIO Pte Ltd, he focused on the discovery and development of drugs for the treatment of cancer – its product Vonjo (pacritinib) is approved in the US. Prior to S*BIO, he was Head of Pharma Global Research at Bayer Healthcare AG and held positions in Rhone-Poulenc Rorer and Astra AB. Jan-Anders received a doctorate in Medical Science (PhD) in Clinical Experimental Pharmacology from the University of Lund, Sweden.

Andreas Schmidt

Board Member

Andreas Schmid has more than 25 years of experience in Finance in the Life Sciences. He worked as a Pharma Analyst at Merrill Lynch and also has experience in fund raising as well as business development.

During the span of his career Andreas was one of the highest-ranked dialysis and generic pharma analysts, with special expertise in European and CEE/emerging markets. His coverage universe included companies such as Fresenius/FMC (Germany), Gambro (Sweden), Stada (Germany) and Aspen (South Africa). Furthermore, he played a major part in the IPOs of Zentiva (Czech Republic) and Hikma (Jordan). Andreas has also been active as a speaker at various industry conferences, for example in New York, Frankfurt, but also in Warsaw and other Eastern European countries.

In addition, Andreas works as finance lecturer at the Hochschule Pforzheim and is a board member of the German shareholder association SdK.

Ricardo Cordero

Vice Chairman
Dr Ricardo Cordero, PhD, serves as Vice Chairman of Opterion Health since 2016. Ricardo has over 30 years of experience in the Financial Services Industry where he held various senior positions, for example as CEO of BZ Bank, Managing Partner at Reichmuth & Co Investmentfonds AG, Co-founder and Co-CEO at BWO Bank, etc. Further, he is a passionate and experienced private Swiss investor and holds various investments in the Life Science, Technology and high-end Consumer Goods industry.

David Ebsworth

Chairman
Dr David Ebsworth, PhD, has been Chairman of Opterion Health since December 2016. David has over 40 years of experience in the Pharma, Healthcare and Biotech industry. David is a past CEO of Galenica, Vifor Pharma as well as Oxford GlycoSciences and past global head of the Pharmaceutical Division of Bayer. He has chaired several private and public companies and has served on numerous boards as either chairman of the audit, remuneration or nominations and governance committees. David is currently Chairman of Verona Pharma and Actimed Therapeutics.