Harmony Biosciences presents ARGUS trial data at American Epilepsy Society

Harmony Biosciences (HRMY) announced the presentation of initial open-label extension data from the company’s ongoing Phase 3 ARGUS trial investigating EPX-100 for the treatment of Dravet syndrome, which showed clinically meaningful reductions in seizure activity in participants with DS along with a favorable benefit-risk profile. The data will be presented at the American Epilepsy Society annual meeting in Atlanta. Data from the eighteen participants in the OLE trial with at least six months’ exposure to EPX-100 demonstrated the following: a median reduction of approximately 50% in countable motor seizure frequency per 28 days; 50% of these participants achieved at least a 50% reduction in CMS-28; EPX-100 was generally well-tolerated in participants receiving treatment for more than two years and approaching three years in the OLE phase. The most common treatment emergent adverse events were seizures, pyrexia and upper respiratory tract infection. There were no significant gastrointestinal adverse events and no additional laboratory testing or special monitoring is being performed in the trial. These data suggest an emerging benefit-risk profile for EPX-100, supported by reduction in seizure frequency and a favorable safety/tolerability profile.