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Published on: May 7, 2020
Preclinical development of an extended half-life anti-myostatin monoclonal antibody
Tom Hsu1, Cody Moore2, Alexander Taguchi2
1iBio, Inc, San Diego, CA, 92121, USA. tom.hsu@ibioinc.com.
Abstract:
Myostatin and growth differentiation factor 11 (GDF11) are closely related members of the transforming growth factor-β superfamily (TGF-β) that negatively regulate skeletal muscle growth. Pharmacologic inhibition of myostatin has been shown to preserve lean mass during glucagon-like peptide-1 receptor agonist (GLP-1RA) -mediated weight loss in persons with obesity. We developed IBIO-600, a long-acting monoclonal antibody which was engineered for dual neutralization of myostatin and GDF11. We evaluated IBIO-600 activity across cellular and preclinical models. Our evaluation of IBIO-600 demonstrated it reverses ligand-mediated suppression of myoblast differentiation in primary human skeletal myoblasts. In mechanistic in vitro studies, we further observed that GDF11 more potently modulates human myocyte and adipocyte biology than myostatin. In diet-induced obese mice treated with GLP-1RA, IBIO-600 preserves lean mass relative to GLP-1RA monotherapy. In aged, obese cynomolgus monkeys, a single administration of IBIO-600 demonstrates an elimination half-life of approximately 52 days and produces sustained improvements in body composition. These findings support further development of IBIO-600 as a differentiated approach to enhance muscle preservation and improve the quality of weight loss achieved with GLP-1RA-based therapies.
Insights
IBIO-600, a novel antibody, preserves lean mass during weight loss treatments. It targets myostatin and GDF11, showing promise for better body composition and muscle health.
Area of Science:
- Biochemistry
- Muscle Biology
- Pharmacology
Background:
- Myostatin and GDF11 are TGF-β superfamily members inhibiting skeletal muscle growth.
- Myostatin inhibition preserves lean mass during GLP-1RA weight loss.
- Obesity and aging can negatively impact muscle mass and quality.
Purpose of the Study:
- To evaluate IBIO-600, a dual myostatin/GDF11 neutralizing antibody, for muscle preservation during weight loss.
- To assess IBIO-600's efficacy in preclinical models, including those treated with GLP-1RA.
- To determine IBIO-600's pharmacokinetic profile and effects on body composition in aged, obese primates.
Main Methods:
- In vitro studies using primary human skeletal myoblasts, myocytes, and adipocytes.
- Preclinical studies in diet-induced obese mice treated with GLP-1RA.
- Pharmacokinetic and body composition analysis in aged, obese cynomolgus monkeys.
Main Results:
- IBIO-600 reversed myoblast differentiation suppression and showed GDF11 as a potent modulator of myocyte/adipocyte biology.
- In mice, IBIO-600 preserved lean mass compared to GLP-1RA monotherapy.
- A single dose in monkeys yielded a ~52-day half-life and sustained improvements in body composition.
Conclusions:
- IBIO-600 effectively neutralizes myostatin and GDF11, demonstrating therapeutic potential.
- IBIO-600 enhances muscle preservation and improves weight loss quality alongside GLP-1RA therapies.
- Further development of IBIO-600 is warranted for obesity and age-related muscle loss.
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