Efficacy outcomes
Mometasone significantly (p=0.0031) reduced the incidence of induration/swelling at 0.5hours post-elamipretide (Table 2). There were trends to significance in reduction of induration/swelling at 1-hour post-dose (p=0.0736) and pruritus at 0.5 hours post-dose (p=0.0573) with mometasone (Tables 2 and 3). Diphenhydramine significantly (p=0.0198) decreased the incidence of induration/swelling at 1-hour post-elamipretide dose, trending to significance (p=0.0698) in reduction of induration/swelling at 0.5 hours post-dose (Table 2). For subject-reported assessment of ISR signs/symptoms, ice application significantly (p=0.0325) reduced the incidence of pain at 0.5 hours post-elamipretide dose (Table 4) and trended to significance (p=0.0573) for reduction of itching at 0.5 hours post-elamipretide dosing (Table 5).Mometasone trended to significant reductions swelling incidence at 1 hour post-elamipretide dose (p=0.3698), bothersome itching at 1 hour post-dose (p=0.1409), and increased redness at 12 hours post-dose (p=0867): the latter attributed to an occlusive dressing reaction. Tacrolimus and doxepin demonstrated no significant differences in ISR signs/symptoms compared to elamipretide administered alone in all clinical and self-assessments.
Injection site photographs aligned with the signs/symptoms of ISRs commonly described following SC administration of elamipretide. Photographs supported the clinical assessments of ISRs conducted at the same timepoints. Overall, photograph-captured ISRs were resolving at 4 hours post-elamipretide dose (exception of bruising which appeared to form after the 12-hour post-dose timepoint in those affected). In the mometasone arm, photographs aided in deciphering erythema grading in subjects where the pattern of redness appeared to be related to the use of the occlusive dressing and not the injection.