Biotech Values

[DewDiligence]

Follow-up on PPL data in CF:

Thank you, drbio, for the posts about the PPL drug candidate in emphysema and CF. I have extracted the tabular data from PPL’s phase-2 study and presented it below to illustrate just how bad this data was.

At all but the highest dose of 250mg/day, efficacy was essentially no better than placebo:

TABLE 1:
NUMBER OF EXACERBATIONS AS A PERCENTAGE OF THE PLACEBO RATE

 
               All Exacerbations     Severe Exacerbations 
 Dose Group  % of placebo  p-value   % of placebo  p-value 
 250 mg/day       75%      0.21           48%      0.08 
 125 mg/day       81%      0.35           94%      0.85 
 62.5 mg/day     106%      0.88          104%      0.91 
 

TABLE 2:
LUNG FUNCTION: PERCENTAGE DIFFERENCE FROM PLACEBO AT SIX MONTHS

 
 Dose Group   VC    FVC    FEV-1 
 250 mg/day   4.3   1.2     2.1 
 125 mg/day  -0.1  -1.2     0.1 
 62.5 mg/day -1.8  -2.3    -0.6 
 

Definitions:
VC is vital capacity, i.e. lung volume normal breathing.
FVC is forced vital capacity, i.e. lung capacity breathing out hard.
FEV-1 is forced expiry volume in one second, i.e. the maximum amount breathed out in one second.

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