Table 7.
AMP-516 analysis of the effect of rintatolimod on the primary endpoint, Exercise Tolerance (ET) [43,44].
| A. Increase in exercise treadmill duration with rintatolimod in CFS patients (intent-to-treat) | |||||
|---|---|---|---|---|---|
| Mean (SD) exercise duration (Seconds) |
Percent increase from baselinea |
||||
| Study interval | Rintatolimod(n = 100) | Placebo (n = 108) |
Rintatolimod (n = 100) | Placebo (n = 108) |
p-value |
| Baseline | 576 (257.5) | 588 (234.4) | - | - | 0.729b |
| Week 40 | 672 (314.1) | 616 (286.7) | 36.5 | 15.2 | 0.047c |
|
p-valued |
|
|
<0.001 |
0.198 |
|
| B. Increase in exercise treadmill duration with rintatolimod in CFS patients (trial completion population) | |||||
| Mean (SD) exercise duration (Seconds) |
Percent increase from Baselinea |
p-value |
|||
| Study interval |
Rintatolimod (n = 93) |
Placebo (n = 101) |
Rintatolimod (n = 93) |
Placebo (n = 101) |
|
| Baseline | 583 (254.7) | 587 (237.3) | - | - | 0.908b |
| Week 40 | 691 (311.4) | 614 (291.2) | 40.2 | 15.6 | 0.019c |
|
p-valued |
|
|
<0.001 |
0.244 |
|
| C. Increase in exercise treadmill duration with rintatolimod in CFS patients without significant dose reductions (intent-to-treat) | |||||
| Mean (SD) exercise duration (Seconds) |
Percent increase from baselinea |
p-value |
|||
| Study interval |
Rintatolimod (n = 83) |
Placebo (n = 98) |
Rintatolimod (n = 83) |
Placebo (n = 98) |
|
| Baseline | 581 (256.2) | 590 (235.3) | - | - | 0.813b |
| Week 40 | 690 (308.2) | 616 (291.4) | 43.0 | 15.0 | 0.022c |
| p-valued | <0.001 | 0.263 | |||
| D. Effect of baseline ET on Week 40 ET (intent-to-treat) | ||||||||
|---|---|---|---|---|---|---|---|---|
| Mean (SD) exercise duration mean (seconds) | % Gain Rintatolimod over Placeboa |
p-valuec | ||||||
| Baseline ET Strata (Minutes) |
≤ 9 Drug (n = 40) |
≤ 9 Placebo (n = 42) |
> 9 Drug (n = 60) |
> 9 Placebo (n = 66) |
≤ 9 | > 9 | ≤ 9 | > 9 |
| Baseline | 321 (153.3) | 353 (144.6) | 747 (148.3) | 738 (137.7) | ||||
| Week 40 | 450 (284.2) | 446 (264.6) | 820 (237.3) | 725 (245.9) | 31.0 | 15.0 | 0.517 | 0.034 |
| E. Mean/Median baseline and Mean/Median change from baseline in exercise treadmill duration (seconds) at Week 24 (Stage 2) (ITT population) | ||||
|---|---|---|---|---|
| Rintatolimod to Rintatolimod |
Placebo to Rintatolimod |
|||
| Exercise tolerance parameter | Mean (SD) | Median | Mean (SD) | Median |
| Baseline ET (seconds) | 706 (308) | 726 | 626 (291) | 638 |
| ET at 24 weeks (seconds) | 696 (323) | 732 | 669 (288) | 665 |
| Percent improvement | 22.9 | - | 39.0 | - |
| p-valuec | 0.58 | 0.69 | 0.04 | 0.02 |
aMean intra-patient percent improvement. bStudent’s t-test comparing mean baseline ET between treatment groups. cAnalysis of covariance (ANCOVA) with baseline as a covariate comparing the mean ET change from baseline within each treatment group. dPaired t-test comparing whether the change from baseline is equal to zero within each treatment group.