BMS Anti-Myostatin Adnectin Program Update and Planned Global Study Announcement

Duchenne Muscular Dystrophy – Anti-Myostatin Adnectin Program (BMS-986089)

  • BMS-986089 is a fully human anti-myostatin adnectin protein targeting Duchenne Muscular Dystrophy. BMS-986089 decreases myostatin, which is known to slow muscle growth.
  • In a Phase 1 study using single and multiple ascending (increasing) doses in normal healthy adults, weekly subcutaneous (under the skin) doses of up to 180 mg BMS- 986089 were safe and well tolerated. The most common adverse effects were mild injection site erythema (redness of the skin), rash and injection site reaction. Increases in thigh muscle volume and total lean body mass in healthy adults were observed following multiple dosing. The extent and duration of free myostatin reduction increased with dose. These data support further study of BMS-986089.
  • An ongoing research study, CN001-006, is evaluating the safety, tolerability and pharmacokinetics of multiple dose ranging subcutaneous doses of BMS-986089 in ambulatory boys with Duchenne Muscular Dystrophy. This study is taking place in the US and in Canada and is now closed to enrollment
  • However, a study that will take place in various countries will soon be recruiting. Bristol-Myers Squibb is planning a global randomized (participants are assigned at random, by chance alone), double-blind (neither the participants nor the study team know who is getting the study drug versus placebo), placebo-controlled study to assess the effectiveness, safety, and tolerability of BMS-986089 in ambulatory boys with Duchenne Muscular Dystrophy. This research study, CN001-016 is projected to start in early 2017.

o The duration of the double-blind period of the study, where a participant may receive the investigational drug or placebo (2:1 ratio, twice as many participants will receive the investigation drug compared to those that receive placebo) is planned for 48 weeks.

o The double-blind period will be followed by an open-label period where active study drug is given to all participants for 48 weeks.

o The study will plan to enroll ambulatory boys 6 to 11 years of age inclusive. Key inclusion criteria include the ability to climb 4 stairs in 8 seconds or less at screening and boys must be receiving corticosteroids for at least 6 months.

V#3 – Feb – US only

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