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

J

jamesB

New member
<a href="http://investors.vrtx.com/releasedetail.cfm?ReleaseID=670755">http://investors.vrtx.com/releasedetail.cfm?ReleaseID=670755</a>

<h2>Interim analysis showed 46% of patients experienced at least 5% absolute improvement in lung function (FEV1) from baseline; 30% of patients experienced at least 10% absolute improvement.</h2>

I did notice that sweat chloride levels didn't show a statistically significant change.
Still encouraging results.
Vertex up 54% premarket.
 
J

jamesB

New member
<a href="http://investors.vrtx.com/releasedetail.cfm?ReleaseID=670755">http://investors.vrtx.com/releasedetail.cfm?ReleaseID=670755</a>

<h2>Interim analysis showed 46% of patients experienced at least 5% absolute improvement in lung function (FEV1) from baseline; 30% of patients experienced at least 10% absolute improvement.</h2>

I did notice that sweat chloride levels didn't show a statistically significant change.
Still encouraging results.
Vertex up 54% premarket.
 
J

jamesB

New member
From the release:
<h1>'People with Cystic Fibrosis Who Have Two Copies of the F508del Mutation'</h1>
 
J

jamesB

New member
From the release:
<h1>'People with Cystic Fibrosis Who Have Two Copies of the F508del Mutation'</h1>
 
J

jamesB

New member
From listening to the conference call, they said the results exceeded expectations.

Didn't release results of the single F508 del as not enough patients have completed enough of the study.
 
J

jamesB

New member
From listening to the conference call, they said the results exceeded expectations.

Didn't release results of the single F508 del as not enough patients have completed enough of the study.
 
J

jamesB

New member
They also said, no reason the current results shouldn't be maintained over the duration of the trial. A 10% increase in FEV was about what they saw in phase 3 trials of 770 for G511D. Moving forward as quickly as possible with further studies to get drug combos to market.
 
J

jamesB

New member
They also said, no reason the current results shouldn't be maintained over the duration of the trial. A 10% increase in FEV was about what they saw in phase 3 trials of 770 for G511D. Moving forward as quickly as possible with further studies to get drug combos to market.
 
J

jamesB

New member
Finally from the call,

Similar level of sweat chloride reductions compared to the earlier studies, but there is no correlation between FEV1 and sweat chloride. FEV1 is what they are focused on.

Accelerated approval is something they'll be discussing with FDA.

Can't comment on what's more important - higher dose or longer duration - results are interim.

Compassionate use - too early to say.

Full results released in a couple of months - probably July.
 
J

jamesB

New member
Finally from the call,

Similar level of sweat chloride reductions compared to the earlier studies, but there is no correlation between FEV1 and sweat chloride. FEV1 is what they are focused on.

Accelerated approval is something they'll be discussing with FDA.

Can't comment on what's more important - higher dose or longer duration - results are interim.

Compassionate use - too early to say.

Full results released in a couple of months - probably July.
 
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