Safety
Apart from data relating to ISRs, which were not captured as AEs
(designated study endpoints), few TEAEs were reported on daily SC
elamipretide 60mg. The only TEAE observed in >one subject
was mild somnolence in the diphenhydramine treatment arm (five subjects
[50%]). It is reasonable to suspect that night-time diphenhydramine
could reduce the occurrence of somnolence, but was not a part of the
study protocol; therefore, a conclusion cannot be drawn. There were no
apparent differences between treatment arms in vital signs, ECG
parameters, or laboratory values.