Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
BYM338 · 6 trials · 4 indications
Safety monitoring was conducted throughout the study. AEs starting on or after the day of first administration of extension study drug until last administration of study drug + 56 days are considered. SAEs starting on or after the day of first administration of extension study drug are considered. Deaths which occurred on or after the day of first administration of extension study drug are considered.
The 6MWD test measures the distance (in meters) that a participant can walk in a 6 minute time frame. A positive change from baseline indicates improvement. The efficacy analysis and time points were based on windowed visits relative to the first dose of the double-blind treatment in the core study.
Any Adverse Event was defined as occurrence of any symptom regardless of intensity grade, Serious Adverse Event (SAEs) assessed as medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in persistent or significant disability/incapacity
The 6MWD test measured the distance (in meters) that a participant walked in a 6 minute timeframe. A positive change from baseline indicates improvement.
Thigh Muscle Volume (TMV) change was evaluated by a responder analysis. Patients whose loss of muscle TMV by MRI was no more than or equal to 2% at Week 4,8,16 and 24 was considered responders.
Change in thigh muscle volume
| Arm | Type | Description |
|---|---|---|
| BYM338/bimagrumab 10 mg/kg | EXPERIMENTAL | Participants received BYM338 10 mg/kg administered via intravenous infusion every 4 weeks for up to a maximum of 8 months after which they entered a 6-month, treatment-free follow-up period. |
| BYM338/bimagrumab 3 mg/kg | EXPERIMENTAL | Participants received BYM338 3 mg/kg administered via intravenous infusion every 4 weeks for up to a maximum of 8 months after which they entered a 6-month, treatment-free follow-up period. |
| BYM338/bimagrumab 1 mg/kg | EXPERIMENTAL | Participants received BYM338 1 mg/kg administered via intravenous infusion every 4 weeks for up to a maximum of 8 months after which they entered a 6-month, treatment-free follow-up period. |
| Placebo | PLACEBO_COMPARATOR | Participants received placebo administered via intravenous infusion every 4 weeks for up to a maximum of 8 months after which they entered a 6-month, treatment-free follow-up period. |
| BYM338 | EXPERIMENTAL | BYM338 Group |
| Name | Type | Description |
|---|---|---|
| Bimagrumab | DRUG | BYM338, a 150 mg/mL concentrate for solution for i.v. infusion, was provided in colorless glass vials with a rubber stopper and aluminum flip-off caps. |
| Placebo | DRUG | Matching placebo to BYM338 was provided in colorless glass vials with a rubber stopper and aluminum flip-off caps. |
| BYM338 (Bimagrumab) | DRUG | - |
| BYM338/bimagrumab | DRUG | BYM338, a 150 mg/mL concentrate for solution for i.v. infusion, was provided in colorless glass vials with a rubber stopper and aluminum flip-off caps. |
| BYM338 | DRUG | BYM338 |
Inclusion Criteria: * Patients who completed the core study * Written informed consent must be obtained before any extension study assessment is performed. * Able to communicate well with the investigator. * Willing to participate for the entire duration of the extension study with commitment to fo...
BYM338 is an investigational drug being studied for conditions involving skeletal muscle, including sporadic inclusion body myositis, sarcopenia, and chronic obstructive pulmonary disease (COPD) with cachexia. It has also been investigated in type 2 diabetes mellitus. BYM338 is in Phase 2 clinical development and is not approved by the FDA.
BYM338 is being developed by Novartis AG, which trades under the ticker NVS. The drug is currently in Phase 2 clinical trials for multiple muscle-related conditions, including sarcopenia and COPD with cachexia.
BYM338 is in Phase 2 clinical development. It has completed three Phase 2 trials, with no active trials currently ongoing. The drug remains investigational and has not received FDA approval.
BYM338 has completed several Phase 2 trials, including NCT01601600 in sarcopenic adults, NCT01669174 in COPD patients with cachexia, NCT02333331 in sarcopenia, and NCT02468674, a 24-week off-drug extension study in sarcopenic elderly. All trials are completed.
BYM338 is also known as bimagrumab. The drug is being studied under the name bimagrumab in clinical trials for sarcopenia and other muscle-wasting conditions. Both names refer to the same investigational compound developed by Novartis.