NIJMEGEN, the Netherlands & Haegendorf, Switzerland – August 18, 2025
Khondrion B.V. and Medvisis Switzerland AG today announced an exclusive licensing agreement for the registration and commercialization of sonlicromanol in Switzerland and Liechtenstein for the treatment of Primary Mitochondrial Diseases (PMD). Under the agreement, Medvisis receives exclusive rights to commercialize sonlicromanol in its territory. Financial terms were not disclosed.
Sonlicromanol, one of the most advanced drug candidates in development for PMD is a disease-modifying, potentially first-in-class, brain-penetrant redox-modulator with antiinflammatory properties, that targets key metabolic and inflammatory pathways underlying PMD.
The investigational drug has been evaluated across multiple clinical studies, and a Phase 3 program is expected to enroll its first patient in Q4 2025.
“We are very excited about our partnership with Medvisis as it marks an important new phase for Khondrion: preparing for the commercialization of sonlicromanol,” said Prof. Jan Smeitink, CEO of Khondrion. “As Khondrion’s first territorial licensing step, this agreement validates the commercial readiness of sonlicromanol and reinforces the company’s commercialization strategy.”
“We are strongly committed to making sonlicromanol available to patients worldwide as soon as possible. This partnership represents an important steppingstone—potentially benefiting approximately 2,000 people living with primary mitochondrial disease in Switzerland and Liechtenstein—as well as a significant milestone for Khondrion.”
“Medvisis is dedicated to bringing innovative therapies for rare diseases to patients in Switzerland and Liechtenstein,” said Manuel Ackermann, CEO of Medvisis. “Sonlicromanol addresses a clear unmet medical need in PMD. We look forward to collaborating closely with Khondrion to advance registration, secure market access and reimbursement, and enable rapid access for patients who are suffering from this debilitating disease.”
Sonlicromanol is an investigational, oral small-molecule redox modulator designed to restore mitochondrial redox homeostasis, normalize aberrant reactive species and prevent consequent cell damage and death.
Sonlicromanol has been investigated in four clinical trials to date. Adult patients participating in Khondrion’s Phase 2 program have reported continued and progressive improvements on key symptoms (see Smeitink et al., Brain, 2025). In addition, patients who elected to participate in a named-patient program following completion of the Phase 2b study have been receiving sonlicromanol for more than three years, supporting the favorable safety profile observed to date. Beyond PMD, a proof-ofconcept clinical trial in post-COVID is expected to enroll its first patient in Q4 2025.
Primary mitochondrial diseases are devastating, progressive, multi-system disorders that affect approximately 1 in 5,000 people. These rare diseases arise from pathogenic variants in either nuclear DNA or mitochondrial DNA that disturb the mitochondrial oxidative phosphorylation (OXPHOS) system—the final biochemical pathway for cellular ATP production. OXPHOS dysfunction impairs ATP generation and triggers downstream cellular stress, disproportionately affecting energy-demanding tissues. Patients frequently suffer from multi-organ involvement, affecting organs and tissues with a high-energy demand like the brain, the eyes, the heart and skeletal muscle leading to cognitive decline, epilepsy, visual impairment, cardiomyopathy (a disease that changes the heart muscle, sometimes causing it to enlarge or stiffen, which can reduce its ability to pump blood), fatigue, exercise intolerance and muscle pain. There are currently no approved disease-modifying therapies for PMD.
Khondrion is a Phase 3 clinical-stage Dutch biopharmaceutical company based in Nijmegen, pioneering disease-modifying therapies for primary mitochondrial diseases caused by defects in mitochondrial oxidative phosphorylation (OXPHOS). The company’s lead asset, sonlicromanol, is in late-stage development with a Phase 3 program in preparation. Sonlicromanol has received orphan drug designations for all inherited mitochondrial oxidative phosphorylation defects in Europe, and for all inherited mitochondrial respiratory chain disorders in the U.S., as well as U.S. rare pediatric disease designation for MELAS. For more information, visit www.khondrion.com.
Medvisis is a Swiss-based pharmaceutical company dedicated to bring transformative rare disease and specialty therapies with high unmet medical need to Swiss patients. A relatively young company, Medvisis unites senior commercial and medical executives from international pharmaceutical companies and Swiss university hospitals, securing unmatched access to national key opinion leaders and other critical healthcare system stakeholers. Medvisis is expanding its portfolio through in-licensing of high-potential therapies driving product registration, reimbursement and commercialization. To learn more, visit www.medvisis.com.
This press release may contain certain forward-looking statements regarding, among other things, the results, conduct, progress and timing of the company’s clinical trials and presentation of data from clinical trials for sonlicromanol. Although the company believes its expectations are based on reasonable assumptions, all statements other than statements of historical fact included in this press release about future events are subject to (i) change without notice and (ii) factors beyond the company’s control. These statements may include, without limitation, any statements preceded by, followed by or including words such as “target,” “believe,” “expect,” “aim,” “goal,” “intend,” “may,” “anticipate,” “foreseen,” “estimate,” “plan,” “project,” “will,” “can have,” “likely,” “potential,” “should,” “would,” “could” and other words and terms of similar meaning or the negative thereof. Forwardlooking statements are subject to inherent risks and uncertainties beyond the company’s control that could cause the company’s actual results, performance or achievements to be materially different from the expected results, performance or achievements expressed or implied by such forward-looking statements. Except as required by law, the company assumes no obligation to update these forward-looking statements publicly, or to update the reasons actual results could differ materially from those anticipated in the forward-looking statements, even if new information becomes available in the future.
E-mail: info@khondrion.com
Tel: +31 24 763 50 00
Website: www.khondrion.com
E-mail: info@medvisis.com
Tel: +41 79 422 14 92
Website: www.medvisis.com
