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Re: mcbio post# 217262

Monday, 03/18/2019 8:52:22 AM

Monday, March 18, 2019 8:52:22 AM

Post# of 257660
ARPO -65%/PM on failed phase-2b in diabetic retinopathy:

https://finance.yahoo.com/news/aerpio-pharmaceuticals-announces-results-time-110000579.html

Administration of AKB-9778 twice daily did not meet the study’s primary endpoint of the percentage of patients with an improvement of two or more steps in the study eye [i.e. the more advanced eye of each patient’s two eyes] diabetic retinopathy severity score (DRSS) compared to placebo. The percentage of patients achieving this endpoint for AKB-9779 twice daily (BID) and placebo were 9.6% and 3.8%, respectively (p=0.270).

In all qualified eyes (i.e., study eyes and fellow eyes [i.e. the second eye in patients who had qualifying disease in both eyes] that met the inclusion/exclusion criteria), the percentage of eyes achieving this endpoint was 8.6% and 2.7%, for AKB-9778 BID and placebo, respectively (p=0.158).

The rates of progression to sight-threatening complications, including diabetic macular edema (DME) and/or proliferative diabetic retinopathy (PDR), during the 48-week treatment period were similar between treatment groups.


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