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ACE-083 Human Trials Phase 1 Results

llawerif

New member
Newbies
Joined
Jun 12, 2018
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Just sharing the recent results of the study for discussion.

"
INTRODUCTION:
ACE-083 is a locally acting follistatin-based therapeutic that binds myostatin and other muscle regulators and has been shown to increase muscle mass and force in neuromuscular disease mouse models. This first-in-human study examined these effects.

METHODS:
In this phase 1, randomized, double-blind, placebo-controlled, dose-ranging study in healthy postmenopausal women, ACE-083 (50-200 mg) or placebo was administered unilaterally into rectus femoris (RF) or tibialis anterior (TA) muscles as 1 or 2 doses 3 weeks apart.

RESULTS:
Fifty-eight postmenopausal women were enrolled, 42 ACE-083 and 16 placebo. No serious adverse events (AE), dose-limiting toxicities, or discontinuations resulting from AEs occurred. Maximum (mean ± SD) increases in RF and TA muscle volume were 14.5% ± 4.5% and 8.9% ± 4.7%, respectively. No significant changes in mean muscle strength were observed.

DISCUSSION:
ACE-083 was well tolerated and resulted in significant targeted muscle growth. ACE-083 may have the potential to increase muscle mass in a wide range of neuromuscular disorders. Muscle Nerve 57: 921-926, 2018.
"

https://www.ncbi.nlm.nih.gov/pubmed/29486514

https://www.mdmag.com/medical-news/orphan-drug-designation-granted-by-fda-to-ace083-for-facioscapulohumeral-muscular-dystrophy
 

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