Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as CK-2127107
Reldesemtiv · 3 trials · 3 indications
The CWR defines how long it takes until the participant reaches symptom limitations while simultaneously being monitored and is called "CWR time to intolerance," which determined the "CWR endurance time". Positive change indicates an improvement from baseline (i.e., a favorable outcome).
Slow vital capacity was measured using a spirometer (in units of liters). Following 3 to 5 breaths at rest, patients were instructed to take as deep an inspiration as possible followed by a maximum exhalation (blowing out all the air in their lungs). Values obtained were converted to percent predicted values using the Global Lung Initiative equation (ie, the test result as a percent of predicted values for patients of similar demographic and baseline characteristics \[eg, height, age, sex\]).
FVC was measured using a calibrated spirometer (in units of liters). Patients were instructed to take as deep an inspiration as possible followed by a maximum exhalation (blowing out all the air in their lungs).
MIP was measured (in units of cm H20) using a calibrated spirometer with an inspiratory pressure valve attached. For the test, patients were asked to inhale as forcefully as possible, to their maximum pressure.
MEP was measured (in units of cm H20) using a calibrated spirometer with an exspiratory pressure valve attached. For the test, patients were asked to maximally inhale then perform a forced exhalation with as forcefully as possible.
Muscle strength of 3 muscle groups (elbow flexion, knee extension, and shoulder abduction) were measured bilaterally using a hand-held dynamometer. Muscle strength was measured twice for each body location; if the variability between the 2 measures was \> 15%, a third measure was obtained. The maximum muscle strength of the 2 measurements was identified and transformed as a percent change from baseline using the equation: (\[postbaseline value - baseline value\] / baseline value) × 100. The mega-score was a composite score that averaged strength across the 3 muscle groups. It was calculated as the mean of the non-missing transformed muscle strength scores among the 3 muscle groups each measure bilaterally (totaling 6 body locations).
The HFMS-E evaluated the level of independent mobility and motor skills through assessment of 33 test-items, each scored from 0 (worse) to 2 (better). The total score was calculated as the sum of the scores among the 33 test items, and has a range from 0 to 66.
The RULM assessed motor function in the upper limbs (specifically shoulder, elbow, wrist, and hand function) that related to activities of everyday life. The RULM consisted of 20 items, 1 of which was scored on a 7-point scale (from 0 to 6), 18 were scored on a 3-point scale (from 0 to 2), and 1 was scored on a 2-point scale (0 or 1). The total score was the sum of each response and could range from a minimum of 0 to a maximum of 43 points. Higher scores reflected better motor function.
The TUG test measured the time (in seconds) it took for a patient to rise from a chair, walk 3 meters, turn around, walk back to the chair and sit down.
The 6MWT measured the distance (in meters) a patient walked in 6 minutes.
Patients assessed whether they felt the same, better, or worse than prior to dosing on Day 1.
The Investigator assessed whether patient appeared the same, better, or worse than prior to dosing on Day 1.
| Arm | Type | Description |
|---|---|---|
| CK-2127107 1000 mg, then placebo | EXPERIMENTAL | Participants received CK-2127107 500 milligram (mg), orally, twice daily for 2 weeks in treatment period 1 followed by matching placebo orally, twice daily for 2 weeks in treatment period 2. A washout period of 2 weeks was maintained between the two treatment periods. |
| Placebo, then CK-212710 1000 mg | EXPERIMENTAL | Participants received matching placebo orally, twice daily for 2 weeks in treatment period 1 followed by CK-2127107 500 mg in treatment period 2. A washout period of 2 weeks was maintained between the two treatment periods. |
| Reldesemtiv 150 mg twice daily | EXPERIMENTAL | Patients in this arm took 1 reldesemtiv 150 mg oral tablet and 2 matching placebo tablets every 12 hours for 12 weeks. |
| Reldesemtiv 300 mg twice daily | EXPERIMENTAL | Patients in this arm took 2 reldesemtiv 150 mg oral tablets and 1 matching placebo tablet every 12 hours for 12 weeks. |
| Reldesemtiv 450 mg twice daily | EXPERIMENTAL | Patients in this arm took 3 reldesemtiv 150 mg oral tablets every 12 hours for 12 weeks. |
| Placebo | PLACEBO_COMPARATOR | Patients in this arm took 3 placebo oral tablets every 12 hours for 12 weeks. |
| Name | Type | Description |
|---|---|---|
| Reldesemtiv | DRUG | Oral tablet |
| Placebo | DRUG | Oral tablet |
| Reldesemtiv 150 mg | DRUG | Granules for oral suspension, 18.7% reldesemtiv |
| Reldesemtiv 450 mg | DRUG | Granules for oral suspension, 56.0% reldesemtiv |
Inclusion Criteria: * Subject has a body mass index (BMI) of 18-35 kg/m2 inclusive. * Subject must have all of the following: * Clinical diagnosis of moderate to severe COPD, with a postbronchodilator FEV1/FVC ratio \< 70% and 30% ≤ FEV1 \< 65% predicted at screening. The predicted values for no...
Reldesemtiv is an investigational small molecule being studied for amyotrophic lateral sclerosis, chronic obstructive pulmonary disease, and spinal muscular atrophy. It has been evaluated in Phase 2 clinical trials in these conditions. It is not approved for any indication and remains in clinical development.
Reldesemtiv is a small molecule activator that targets the fast skeletal muscle troponin complex, specifically TNNI2, TNNT3, and TNNC2. By acting on these proteins, it aims to increase the sensitivity of muscle fibers to calcium, potentially enhancing muscle contraction. This mechanism is being explored in conditions involving muscle weakness.
Reldesemtiv is being developed by Cytokinetics, Incorporated, which trades on the Nasdaq under the ticker CYTK. Cytokinetics is a biopharmaceutical company focused on muscle biology and related therapeutics.
Reldesemtiv is in Phase 2 clinical development. It has completed Phase 2 trials in amyotrophic lateral sclerosis, chronic obstructive pulmonary disease, and spinal muscular atrophy. It is not approved by the FDA and remains investigational.
Reldesemtiv has been studied in three completed Phase 2 trials: NCT03160898 in amyotrophic lateral sclerosis with 458 participants, NCT02662582 in chronic obstructive pulmonary disease with 46 participants, and NCT02644668 in spinal muscular atrophy with 70 participants. All trials were randomized, double-blind, and placebo-controlled.