A chance to extend functional independence
RELYVRIO may help you maintain physical function longer so that you may continue to do the things you enjoy.
Slow DISEASE progression
The results from the CENTAUR clinical trial showed that RELYVRIO gave participants a chance to extend their functional independence by slowing the progression of ALS.
POINTS HIGHER THAN THE
PLACEBO GROUP, ON AVERAGE
on the ALSFRS-R after 6 months of treatment.
Individual results may vary.
AVERAGE ALSFRS-R
SCORE AT 6 MONTHS
POINTS HIGHER THAN THE
PLACEBO GROUP, ON AVERAGE
on the ALSFRS-R after 6 months of treatment.
Individual results may vary.
What is the ALSFRS-R score?
RESPIRATORY
12 Points
BULBAR
12 Points
GROSS MOTOR
12 Points
FINE MOTOR
12 Points
WHAT DO 2 TO 3 POINTS REALLY MEAN?
A 2- to 3-point higher score could mean having a greater ability to breathe, speak, and walk, which may impact the ability to live more independently.
While ALS affects everyone differently, 2 points could make a big difference in someone’s life. It could mean:
- Maintaining the ability to walk down the street while holding hands with your partner
- Continuing to be able to talk on the phone and catch up with your favorite nephew
- Maintaining your ability to physically stand up and speak clearly as an ALS advocate
How RELYVRIO was studied
THE CENTAUR CLINICAL TRIAL FOR RELYVRIO
RELYVRIO was studied in the CENTAUR clinical trial, which had 2 phases:
1
Randomized phase (vs placebo)
- 6 months
- 137 randomized participants (89 took RELYVRIO, 48 placebo)
- Participants also took other FDA-approved ALS therapies (71% took riluzole and 34% took edaravone)
MAIN GOAL: Study the safety and if RELYVRIO has an impact on slowing the rate of disease progression in ALS*
2
Open-label extension phase (all treated with RELYVRIO)
- Up to ~35 months
- 90 participants (56 continued on RELYVRIO and 34 started on RELYVRIO from the CENTAUR trial)
- Participants were able to continue with other FDA-approved ALS therapies
MAIN GOAL: Study long-term safety of RELYVRIO
*As measured by the rate of decline in ALSFRS-R total score from start of trial through trial end at 6 months.
An exploratory analysis of survival
After the CENTAUR clinical trial was completed, a “post hoc” exploratory survival analysis observed that participants originally randomized to RELYVRIO saw a 4.8-month longer median overall survival compared with the placebo group.
This exploratory analysis should be interpreted cautiously given limitations.
LIMITATIONS OF THE ANALYSIS
Some of the survival data analyzed included participants who were no longer being followed as closely as in the randomized phase of the clinical trial.
Some of these participants may have had procedures or taken therapies that may have impacted survival and were not included in the analysis, which could make the results for RELYVRIO appear better or worse than they actually are. Some examples include:
- Tracheostomy
- Starting permanent assisted ventilation
- Starting or stopping other FDA-approved therapies for ALS
RELYVRIO WAS GENERALLY WELL-TOLERATED
In the CENTAUR clinical trial for RELYVRIO, the most common side effects were:
- Diarrhea
- Abdominal pain
- Nausea
- Upper respiratory tract infection
Gastrointestinal side effects occurred throughout the study but were more frequent during the first 3 weeks of treatment.
ADVERSE REACTIONS REPORTED IN MORE THAN 5% OF RELYVRIO-TREATED PARTICIPANTS WITH ALS AND AT LEAST 5% GREATER THAN PLACEBO (CENTAUR)
Adverse Reaction
RELYVRIO
n=89
(%)
PLACEBO
n=48
(%)
Diarrhea*
25
19
Abdominal pain*
21
13
Nausea
18
13
Upper respiratory tract infection*
18
10
Fatigue*
12
6
Salivary hypersecretion
11
2
Dizziness
10
4
*Adverse reaction is composed of several similar terms.
