KHENERFIN is a Phase 3 study investigating whether sonlicromanol improves fatigue (lack of energy), muscle weakness, and other symptoms in people living with m.3243A>G Primary Mitochondrial Disease, including classic MELAS, MIDD and Multi-system Phenotypes.
KHENERFIN is a blinded, placebo-controlled study in which half of the patients will receive sonlicromanol and the other half placebo. The first wave of the study will include 40 participants; the second will include an additional 110 participants.
The first phase of the study will begin at 10 locations across 8 countries, including sites in the European Union and the United States.
Door-to-door travel support for participants
Multiple study locations
Access to sonlicromanol for all participants in a planned compassionate use program
Sonlicromanol is an investigational medicine that is taken as a twice-a-day oral tablet. Sonlicromanol has been studied in a Phase 1 study in healthy volunteers, in three studies (KHENERGY, KHENERGYZE AND KHENEREXT) in participants with m.3243A>G PMD and in one study (KHENERGYC) in children with PMD. A Named Patient Program with up to 2½ years favorable safety data is ongoing.
KH stands for Khondrion who’s aim is to bring ENERGY back to patients. FIN stand for FINAL meaning that this study being the last study before market authorization.
To be considered for participation in KHENERFIN, the individuals must:
Final eligibility will be determined by the study doctor.
To learn more about KHENERFIN, contact study staff directly using the contact information provided on clinicaltrials.gov [NCT06451757] or email khenerfin@khondrion.com.
