Efficacy outcomes
With respect to clinical assessment of ISR signs and symptoms, mometasone significantly (p=0.0031) reduced the incidence of induration/swelling at 0.5 hours post-elamipretide dose (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 with a trend to significance (p=0.0698) in reduction of induration/swelling at 0.5 hours post-dose (Table 2). With respect to subject-reported assessment of ISR signs and symptoms, ice application significantly (p=0.0325) reduced the incidence of pain at 0.5 hours post-elamipretide dose (Table 4) and there was a trend to significance (p=0.0573) for reduction of itching at 0.5 hours post-elamipretide dosing (Table 5).With mometasone, there were trends to significance to reductions in the incidence of swelling 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 believed to be attributable to a reaction to the occlusive dressing. Tacrolimus and doxepin demonstrated no significant differences in ISR signs and symptoms compared to elamipretide administered alone in all clinical and self-assessments.
The injection site photographs collected aligned with the signs and symptoms of ISRs commonly described following administration of elamipretide by SC injection. In addition, the photographs supported the clinical assessments of the ISRs that were conducted at the same timepoints. Overall, the ISRs captured on the photographs were resolving at 4 hours post-elamipretide dose with the exception of bruising, which appeared to form after the 12-hour post-dose timepoint in those affected. In the mometasone arm, the 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.