How does BMS-98609 work?
Muscle cells, like most cells, divide to form identical ones, which increases the size of the muscle tissue. The period it takes for a cell to originate a new one is termed the cell’s “life cycle.” During this process, cells evolve through several stages prior to dividing as the final step. In the first moments of the cycle, the cell grows bigger to then allow for division and separation to occur in the next stages. Myostatin is a hormone produced in muscle tissue that inhibits the growth and differentiation of muscle cells by arresting the cell cycle at the initial phase during cellular growth.
BMS-98609 works by binding myostatin and forbidding it to act on its target cell, therefore allowing cellular division and proliferation. Researchers believe the drug will help patients with DMD by increasing muscle mass, which is normally low in these patients.
Studies of BMS-98609
Bristol-Myers Squibb has three ongoing clinical trials to test the efficiency of BMS-98609 in the treatment of DMD. One is a Phase 1, open-label, randomized, parallel-group, single dose study to compare the bioavailability of subcutaneous injections of BMS-986089 in the arm, thigh and abdomen (NCT03100630). The trial also will evaluate the safety, tolerability, pharmacokinetics and immunogenicity of BMS-986089 in healthy participants.
Another clinical trial is a Phase 1/2 multi-site, randomized, placebo-controlled, double-blind, multiple ascending subcutaneous dose study to evaluate the safety, tolerability and pharmacokinetics of BMS-986089 in ambulatory boys with DMD (NCT02515669). The trial is taking place in the United States and Canada.
The third clinical trial is a Phase 2/3 randomized, double-blind, placebo-controlled, study to assess the effectiveness, safety and tolerability of two different weekly doses of BMS-986089 in ambulatory boys with DMD (NCT03039686).