Muscle atrophy is a medical condition where the human body begins to lose muscle tissue. Primary causes include malnutrition, age, genetics, and lack of physical activity. It affects 1 in 8,000–10,000 worldwide. With a total of only three drug candidates approved for the treatment of muscle atrophy, and only one currently in the US, there is a race to bring new treatments to market.
There are currently 191 muscle atrophy clinical trials in GlobalData’s Pharma Intelligence Centre. Both industry and non-industry sponsors top the list, with McMaster University and Novartis being the top with four trials each (Figure 1). BioAge Labs, which currently has two trials, recently reported positive results from one of those.
BioAge Labs is a drug development company based in Richmond, California, that focuses on the treatment of therapy areas and indications that cause ageing. On 5 December, BioAge Labs reported positive topline results from its Phase Ib clinical trial testing BGE-105 for the treatment of muscle atrophy in 21 older subjects, age 65 or above. BGE-105, also known as azelaprag, acts as an apelin receptor agonist. Apelin is a small, secreted peptide hormone that regulates multiple aspects of muscle physiology, including cell growth and survival, regeneration and repair, and thus alleviates the disease condition. In this Phase Ib trial, the drug was administered intravenously.
Results included significant improvement in muscle size, quality and protein synthesis during ten days of bed rest compared with a placebo, and there were no serious adverse events. BioAge Labs plans to move forward and initiate a Phase II trial in the prevention of ICU diaphragmatic atrophy and critical illness myopathy; this trial is anticipated to begin next year.