VX 809/770 Phase 2 interim results - 5-10% improvement in lung function

T

trw144

New member
Yes, the 46% over 5% FEV increase also includes the 30% that saw a 10% increase. It must be noted though that the study was split into three groups - all had the same dosage of kalydeco (vx-770) but the VX-809 dosage was varied between the three groups (200mg,400mg,600mg). They would nt say in the conference call but I was wondering whether their was a correlation between the FEV increase and the dosage - hence not everyone in the study achieved the same levels of increase (maybe this is just wishful thinking).

Anyway, Vertex have seen enough that they are pushing ahead with the next stage and are not going to wait for the results of VX-661 (which it had been suggested was the better potentiator).
 
T

trw144

New member
Yes, the 46% over 5% FEV increase also includes the 30% that saw a 10% increase. It must be noted though that the study was split into three groups - all had the same dosage of kalydeco (vx-770) but the VX-809 dosage was varied between the three groups (200mg,400mg,600mg). They would nt say in the conference call but I was wondering whether their was a correlation between the FEV increase and the dosage - hence not everyone in the study achieved the same levels of increase (maybe this is just wishful thinking).

Anyway, Vertex have seen enough that they are pushing ahead with the next stage and are not going to wait for the results of VX-661 (which it had been suggested was the better potentiator).
 
S

saveferris2009

New member
5% increase in FEV1 isn't too impressive, in my book. So for example, if you have an 80% FEV1, you would then be at 84%. Cool, but not amazing. The 20% FEV1 from Kalydeco with G551D is more impressive.

But I'll take whatever I can get. I'm just not surprised that they'll still be studying 661
 
S

saveferris2009

New member
5% increase in FEV1 isn't too impressive, in my book. So for example, if you have an 80% FEV1, you would then be at 84%. Cool, but not amazing. The 20% FEV1 from Kalydeco with G551D is more impressive.

But I'll take whatever I can get. I'm just not surprised that they'll still be studying 661
 
H

hbollotte

New member
as someone asked in an earlier post, while taking this drug does the patient stay on their breathing treatment regimen????
 
H

hbollotte

New member
as someone asked in an earlier post, while taking this drug does the patient stay on their breathing treatment regimen????
 
M

musclemania70

New member
I think it depends on the patient whether or not he or she would continue with treatments. As with Brady, he is young enough that he has no damage and is slowly decreasing his treatments as time goes on (g551d).

Each patient would probably have to use their judgment with their doctor's guidance about how to proceed with treatments in the future if their lung function improves with the new drugs.

Each patient will have to be handled case to case. Young ones with the least lung disease will have the best chances for staying treatment free......
 
M

musclemania70

New member
I think it depends on the patient whether or not he or she would continue with treatments. As with Brady, he is young enough that he has no damage and is slowly decreasing his treatments as time goes on (g551d).

Each patient would probably have to use their judgment with their doctor's guidance about how to proceed with treatments in the future if their lung function improves with the new drugs.

Each patient will have to be handled case to case. Young ones with the least lung disease will have the best chances for staying treatment free......
 
B

bkc3

New member
It is exciting to see progress. Looking forward to more information as the trial moves forward.
 
B

bkc3

New member
It is exciting to see progress. Looking forward to more information as the trial moves forward.
 
H

hammerpocket

Guest
<div class="FTQUOTE"><begin quote><i>Originally posted by: <b>saveferris2009</b></i> 5% increase in FEV1 isn't too impressive, in my book. So for example, if you have an 80% FEV1, you would then be at 84%. Cool, but not amazing.</end quote>
I made this point in the other thread, but I'll repeat it here:
I think we may be reading this wrong. Notice the change is written as "an absolute improvement ... of 5 percentage points" rather than "a 5% improvement." If I understand it coreectly, an "absolute improvement" is the improved percentage<em>minus</em>the original precentage. In your example, the FEV1 of 80% with an absolute improvement of 5 percentage points would be 85%. (A <em>relative improvement</em>of 6.25%.) That may not seem impressive, but if the FEV1 started at 50%, the absolute improvement would result in FEV1=55% (or a 10% relative improvement).
And remember, 30% had an absolute improvement of <em>10</em>precentage points.
 
H

hammerpocket

Guest
<div class="FTQUOTE"><begin quote><i>Originally posted by: <b>saveferris2009</b></i> 5% increase in FEV1 isn't too impressive, in my book. So for example, if you have an 80% FEV1, you would then be at 84%. Cool, but not amazing.</end quote>
I made this point in the other thread, but I'll repeat it here:
I think we may be reading this wrong. Notice the change is written as "an absolute improvement ... of 5 percentage points" rather than "a 5% improvement." If I understand it coreectly, an "absolute improvement" is the improved percentage<em>minus</em>the original precentage. In your example, the FEV1 of 80% with an absolute improvement of 5 percentage points would be 85%. (A <em>relative improvement</em>of 6.25%.) That may not seem impressive, but if the FEV1 started at 50%, the absolute improvement would result in FEV1=55% (or a 10% relative improvement).
And remember, 30% had an absolute improvement of <em>10</em>precentage points.
 
B

byrne819

New member
Can anyone speculate on the timing between now and potential FDA approval? I'm assuming final results will be released in July or August. When does Phase III begin? Then how long until FDA approval?
 
B

byrne819

New member
Can anyone speculate on the timing between now and potential FDA approval? I'm assuming final results will be released in July or August. When does Phase III begin? Then how long until FDA approval?
 
You must log in or register to reply here.
Top