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TIME-2b Disappointed: Aerpio’s Lead Product Fails In Diabetic Retinopathy

 
• By Alexandra Shimmings

As its lead product fails at Phase IIb in diabetic retinopathy, Aerpio’s attentions turn to its other potential indications, but investors will need more convincing that this strategy will pay dividends.

Time
A Time To Proceed And A Time To Give Up

Cincinnati, OH-based Aerpio Pharmaceuticals Inc. is facing a more difficult future after its lead product, AKB-9778, failed in a Phase IIb study in moderate to severe non-proliferative diabetic retinopathy (NPDR). Shares in the firm on NASDAQ dropped by more than 71% to close at $1.22 on March 18, having dropped to an all-time low of $1.20 during the day.

Twice-daily subcutaneous AKB-9778 did not meet the 167-patient TIME-2b study’s primary endpoint of the percentage of patients with an improvement of two or more steps in the study eye diabetic retinopathy severity score (DRSS) compared with placebo, the primary endpoint (see table). Nor did the drug produce a significant improvement on the same scale in all qualified eyes (i.e., study eyes and fellow eyes that met the inclusion/exclusion criteria)

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