Ace-083 peptide is an investigational protein therapeutic designed to increase muscle mass and strength in specific muscles and muscle groups. It is being developed for diseases where improved muscle strength may provide a clinical benefit, such as inclusion body myositis and certain forms of muscular dystrophy. Ace-083 has attracted attention in the research community. This comprehensive guide will delve into the pharmacokinetics, mechanism of action, scientific studies, and potential applications of Ace-083. Plus, where to buy ACE-083 peptide for research use!
What is ACE-083?
ACE-083 is an investigational drug containing a modified form of human follistatin that binds myostatin and other muscle regulators. ACE-083 is a locally acting drug that has been shown to increase muscle growth in a clinical trial involving healthy postmenopausal women. The study administered ACE-083 unilaterally into rectus femoris or tibialis anterior muscles as one or two doses three weeks apart, and no serious adverse effects or dose-limiting toxicities occurred. ACE-083 may have the potential to increase muscle mass in a wide range of neuromuscular disorders. Study A083-02 is a Phase 2 clinical trial designed to evaluate the safety, tolerability, pharmacodynamics, efficacy, and pharmacokinetics of ACE-083 in patients with muscle weakness in certain conditions.
Ace-083 is a locally acting follistatin-based therapeutic that binds myostatin and other muscle regulators, leading to increased muscle mass and force in neuromuscular disease mouse models. This first-in-human study examined these effects. Pharmacokinetics is the study of how a drug is absorbed, distributed, metabolized, and eliminated by the body. It involves examining the time course and magnitude of drug exposure in the body, as well as understanding factors that can affect drug concentration levels, such as age, gender, genetics, and co-administration with other drugs
In a 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.
Fifty-eight postmenopausal women were enrolled in the study, with 42 receiving Ace-083 and 16 receiving placebo. No serious adverse events (AEs), dose-limiting toxicities, or discontinuations due to AEs occurred. Maximum mean (± standard deviation [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.
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.
Mechanism of Action
FSHD is a disease characterized by the progressive weakening of muscles, starting in the face, shoulders, and upper arms. Ace-083 is designed to increase the strength and function of specific muscles.
How ACE-083 Works
The therapy contains a small molecule that binds to and inhibits select proteins in the TGF-beta protein superfamily, namely activins and myostatin, which reduce muscle growth. Normally, muscle size is controlled by a balance of building and breaking down muscle. Exercise helps muscles to grow. If a person stops exercising, the muscles gradually reduce in size due to the function of activins and myostatin, among other factors.
Inhibiting the TGF-beta family, sometimes called the “myostatin +” approach, reduces or slows muscle breakdown. This approach is thought to increase muscle mass and strength where the treatment is administered. Untreated muscles or other organs are not affected, which reduces the potential of side effects.
Scientific Studies With ACE-083
There have been multiple human and animal studies of Ace-083, pointing towards a correlation between its administration and local muscle growth.
ACE-083 is an investigational drug that has been studied in a Phase 2 clinical trial to evaluate its safety, tolerability, pharmacodynamics, efficacy, and pharmacokinetics.
The study aimed to increase muscle volume and improve functional outcomes in adults with FSHD, a slowly progressive muscular dystrophy. The study consisted of two parts: Part 1 was open-label ascending dose, assessing safety, and tolerability. While Part 2 was randomized, double-blind for six months, evaluating ACE-083240 mg/muscle vs placebo injected bilaterally every 3 weeks in the biceps brachii or tibialis anterior muscles, followed by six months of open-label.
The results showed that ACE-083 resulted in a significant increase in total muscle volume, but no consistent improvement in functional or PRO measures in either group. ACE-083 is a locally acting drug that works by increasing muscle growth in neuromuscular disorders. Furthermore, pharmacokinetics is the study of how a drug is absorbed, distributed, metabolized, and eliminated by the body.
In one animal study, subjects were injected with Ace-083 twice per week, over four weeks. Findings indicated muscle growth localized to the site of injection.
Another study conducted on postmenopausal women provided similar findings. All 42 non-placebo subjects appeared to demonstrate higher muscle volume where Ace-083 was injected. Both of these studies show that this peptide may promote higher rates of muscle growth.
Ace-083 vs. Ace-031
Ace-083 works similarly to Ace-031; however, Ace-083 is designed to only increase muscle mass in the muscle that is treated.
In preclinical animal studies, Ace-083 has shown selective and dose-dependent increases in muscle mass in treated muscles with no effects in untreated muscles.
Phase 2 Trial Results
Acceleron Pharma announced topline results from the phase 2 trial of Ace-083 in patients with Charcot-Marie-Tooth disease. Ace-083 did not achieve statistically significant improvements in functional endpoints relative to placebo. Acceleron has decided to discontinue the development of Ace-083.
Legal Status and Availability
Ace-083 is sold for research purposes only. It is intended for in vitro testing and laboratory experimentation only. Bodily introduction of any kind into humans or animals is strictly forbidden by law. This product is not for human use and can be harmful if ingested.
Warnings and Precautions
Ace-083 is a very potent research peptide. The product is not in a sterile solution and is not to be injected. This product should only be handled by licensed, qualified professionals. This product is not a drug, food, or cosmetic and should not be misbranded, misused, or mislabeled as a drug, food, or cosmetic.
Despite the discontinuation of Ace-083’s development for Charcot-Marie-Tooth disease, its potential applications in other neuromuscular disorders are still being explored. Researchers are investigating the possibility of using Ace-083 to treat inclusion body myositis and certain forms of muscular dystrophy, where improved muscle strength may provide a clinical benefit.
Conclusion: BUY ACE-083 PEPTIDE FOR STUDY ONLY
Ace-083 is an intriguing investigational peptide that has shown potential in increasing muscle mass and strength in specific muscles and muscle groups. While its development for Charcot-Marie-Tooth disease has been discontinued, researchers continue to explore its potential applications in other neuromuscular disorders. As a potent peptide, Ace-083 should be handled with caution and used strictly for research purposes.
- MDA Strongly – FDA Grants Orphan Drug Designation to Acceleron Pharma’s Ace-083
- Neuromuscular Disorders Journal – Abstract
- Acceleron Pharma – Ace-083 Ligand Trap
- PubMed – First-in-human study of ACE-083
- Charcot-Marie-Tooth News – Preliminary CMT Phase 2 Trial Results