RELYVRIO™ is an FDA-approved, oral fixed-dose combination treatment for ALS in adults shown to help slow the loss of physical function1
See trial design and function and survival data below
The CENTAUR trial
The CENTAUR trial was designed in collaboration with clinical leaders, advocacy groups, and people living with ALS2-4
*The OLE phase of CENTAUR included 56 participants from RELYVRIO group and 34 participants from the placebo group (n=90).
The OLE phase evaluated long-term safety and efficacy for up to 152 weeks, during which all participants were taking RELYVRIO + SOC.
The 2 Phases of the CENTAUR trial
- CENTAUR was a multicenter study in adults with ALS that encompassed:
- Randomized phase: A 24-week, randomized, double-blind, placebo-controlled phase (2:1 RELYVRIO to placebo)1
- OLE phase: An open-label phase that evaluated long-term safety and efficacy for up to 152 weeks2
Abbreviation: SOC, standard of care.
Key inclusion criteria1
- Diagnosis of definite sporadic or familial ALS per revised El Escorial criteria
- ≤18 months since ALS symptom onset
- Slow vital capacity >60% of predicted value
Results were published in the
New England Journal of Medicine2
Key elements of the CENTAUR trial1,3
Primary efficacy end point
The primary end point of the randomized phase was a comparison of reduction rate of decline in ALS Functional Rating Scale-Revised (ALSFRS-R) total score between RELYVRIO + SOC and placebo + SOC from baseline to 6 months.1
Baseline characteristics were generally balanced1
- On average, participants in both arms had been diagnosed with ALS 6 months prior to baseline1
- In both arms, the average time since onset of first ALS symptom was approximately 13.5 months1
- The RELYVRIO arm had a higher percentage of trial participants with bulbar-onset disease vs the placebo arm (30% vs 21%, respectively)1
The majority of participants in CENTAUR were taking concomitant riluzole and/or edaravone1
- At or prior to study entry, 71% of participants were taking riluzole and 34% were taking edaravone1
- 77% of participants took either or both of these FDA-approved ALS medications5
- The CENTAUR trial was not designed to be a head-to-head comparison with other therapies for ALS1
RELYVRIO FUNCTION DATA (24 weeks)
RELYVRIO significantly slowed functional decline vs placebo1
MODIFIED INTENT-TO-TREAT (mITT) POPULATION (N=135):
ALSFRS-R TOTAL SCORE OVER 24 WEEKS1
MODIFIED INTENT-TO-TREAT (mITT) POPULATION (N=135):
ALSFRS-R TOTAL SCORE OVER 24 WEEKS1
Originally randomized to RELYVRIO + SOC (n=87)
Originally randomized to placebo + SOC (n=48)
2.32-point
differenceat the end of the 6-month
randomized phase (P=0.034)
95% CI: 0.18-4.47
Learn more about the ALSFRS-R scale7
EACH POINT DECREASE ON THE ALSFRS-R REPRESENTS LOST CAPABILITY IN PERFORMING ACTIVITIES FUNDAMENTAL TO DAILY LIFE.
Comprising 12 items in 4 domains, each of these is measured on a scale of 4 to 0, with lower scores indicating less capability.
The ALSFRS-R is a validated, questionnaire-based tool for evaluating decline in physical function over time.
BULBAR Example: swallowing 
GROSS MOTOR Example: climbing stairs 
FINE MOTOR Example: dressing/hygiene 
RESPIRATORY Example: respiratory insufficiency Score of 4
Normal eating habits
Normal
Normal function
None
Score of 3
Early eating problems— occasional choking
Slow
Independent and complete self-care with effort or decreased efficiency
Intermittent use of bilevel positive airway pressure (BiPAP)
Score of 2
Dietary consistency changes
Mild unsteadiness or fatigue
Intermittent assistance or substitute methods
Continuous use of BiPAP during the night
Score of 1
Needs supplemental tube feeding
Needs assistance
Needs attendant for self-care
Continuous use of BiPAP during the night and day
Score of 0
NPO (exclusively parenteral or enteral feeding)
Cannot do
Total dependence
Invasive mechanical ventilation by intubation or tracheostomy
BULBAR
Example: swallowing
GROSS MOTOR
Example: climbing stairs
FINE MOTOR
Example: dressing/hygiene
RESPIRATORY
Example: respiratory insufficiency
- Mean ALSFRS-R total score was 2.32 points higher at week 24 compared to placebo (P=0.034)
- As early as 6 weeks after treatment initiation, RELYVRIO showed slowing of progression1
- Concomitant treatment with available therapies did not impact the primary outcome6
aThe post hoc intent-to-treat (ITT) analysis, including all 137 randomized participants, yielded results that were identical (within rounding error) to the primary mITT analysis (P=0.03).1
Abbreviation: SOC, standard of care.
RELYVRIO SURVIVAL DATA (AT UP TO 42 MONTHS FROM RANDOMIZATION)*
In a post hoc exploratory analysis, longer median overall survival was observed in participants originally randomized to RELYVRIO1
This exploratory analysis should be interpreted cautiously given the limitations of data collected outside of a controlled study, which may be subject to confounding.1
OVERALL SURVIVAL ANALYSIS AT THE END OF THE OLE PHASE (UP TO 42 MONTHS FROM RANDOMIZATION)
ITT POPULATION (N=137)8
OVERALL SURVIVAL ANALYSIS AT THE END OF THE OLE PHASE (UP TO 42 MONTHS FROM RANDOMIZATION)
ITT POPULATION (N=137)8
Originally randomized to placebo + SOC (n=48)
Originally randomized to RELYVRIO + SOC (n=89)
A 4.8-month
longer median
overall survival8,a was observed in the group originally randomized to RELYVRIO + SOC
compared to those originally
randomized to placebo + SOC
(HR, 0.644;
95% CI, 0.416-0.995)
Vital status was ascertained in 136 of 137 participants who were enrolled in CENTAUR.
Longer median overall survival was observed in the participants originally randomized to RELYVRIO + SOC compared to those originally randomized to placebo + SOC.1
*Up to 42 months from randomization; last participant, last visit in OLE phase. aMedian survival is the time at which 50% of participants have died. Abbreviations: CI, confidence interval; HR, hazard ratio; ITT, intent to treat; NR, not reached.
Learn about the safety data of RELYVRIO
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