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.