Approval Probability
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Adjusted LOA
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bimagrumab · 3 trials · 2 indications
SPPB evaluates lower extremities in three functional components: maintenance of standing balance, usual gait speed and chair stand. Each test yields a score on a scale from 0 to 4 (total score 0-12, with the higher score reflecting a higher level of function).
SPPB evaluates lower extremities in three functional components: maintenance of standing balance, usual gait speed and chair stand. Each test yields a score on a scale from 0 to 4 (total score 0-12, with the higher score reflecting a higher level of function).
Change from Baseline in total Short Physical Performance Battery (SPPB) Score to week 25; SPPB is a series of six activities involving three domains of physical function - balance, usual walking speed and rising from a chair , is commonly used globally to assess and quantify (score 0-12) lower extremity function and has been shown to predict future adverse health events. A decline of one or more points in the SPPB total score is predictive of a decrease in lower extremity function and future adverse clinical outcomes in older adults, including falls, hospitalizations, institutionalization, incident disability and death
Mixed Model for Repeated Measures (MMRM) of change from baseline in total LBM (kg) by treatment and visit To assess dose-response relationship of bimagrumab and facilitate an adequate dose selection for future phase III studies, without the need for supportive data from another dose-response finding study, at least three doses were required, ranging from a non-effective or minimally effective dose to a dose where maximal efficacy is expected. Original study was initiated with only two doses of bimagrumab, therefore, a lower dose arm of 70mg has been added to this study with Amendment 2, changing the randomization ratio from 1:1:1 to 2:1:2:2 to either placebo, bimagrumab 70mg, bimagrumab 210mg, or bimagrumab 700mg. Since the 70mg dose was expected to show suboptimal efficacy and fewer patients were randomized to this group, it was used only for dose response modelling and not for hypothesis testing. Consequently, no efficacy evaluations for the bimagrumab 70mg Arm were performed
| Arm | Type | Description |
|---|---|---|
| Follow-up (arm 1) | OTHER | Patients in Population I received 6 doses of bimagrumab 70 mg, 210 mg, 700 mg or placebo - one approximately every four weeks - over a 20-week period providing drug exposure for a total of 24 weeks. |
| Follow-up (arm 2) | NO_INTERVENTION | Patients in Population II received either bimagrumab 700 mg or placebo in the core study and did not receive any investigational treatment in the extension study. |
| BYM338 70 mg | EXPERIMENTAL | BYM338 70 mg intravenous infusion |
| BYM338 210 mg | EXPERIMENTAL | BYM338 210 mg intravenous infusion |
| BYM338 700 mg | EXPERIMENTAL | BYM338 700 mg intravenous infusion |
| Placebo | PLACEBO_COMPARATOR | Placebo intravenous infusion |
| bimagrumab 700 mg | EXPERIMENTAL | Approximately 70 patients who met all inclusion criteria and none of the exclusion criteria were treated with the bimagrumab high dose administered via intravenous infusion starting Day 1 until Week 20 |
| bimagrumab 210 mg | EXPERIMENTAL | Approximately 70 patients who met all inclusion criteria and none of the exclusion criteria were treated with the bimagrumab medium dose administered via intravenous infusion starting Day 1 until Week 20 |
| Bimagrumab 70 mg | EXPERIMENTAL | Approximately 35 patients who met all inclusion criteria and none of the exclusion criteria were treated with bimagrumad low dose administered via intravenous infusion starting Day 1 until Week 20 |
| Name | Type | Description |
|---|---|---|
| bimagrumab | DRUG | bimagrumab low dose bimagrumab moderate dose bimagrumab high dose Patients enrolled prior to the protocol amendment 1 (Population I ), who received bimagrumab in the core study, entered the extension study at Week 25 and were randomly assigned to two subgroups within each of three treatment arms to either receive bimagrumab at the same dose level or placebo. Study medication was administered as an intravenous infusion starting at Week 25 after treatment was initiated in the core study until week 45. |
| Placebo | DRUG | Placebo Patients enrolled prior to the protocol amendment 1 (Population I), who received placebo in core study, entered the extension study at Week 25 and received placebo as an intravenous infusion starting at Week 25 after treatment was initiated in the core study until week 45. |
Inclusion criterion: \- Men and postmenopausal women aged 70 years or older that have participated in, and have completed the full study treatment period per protocol (24 weeks/EOT visit) in the preceding core study (CBYM338E2202) Exclusion criterion: \- Any condition which should have led to tre...
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.