Dipexium Pharmaceuticals ($DPRX) saw its shares fall by more than 80% premarket on the news that two of its Phase III programs missed the primary and secondary endpoints in diabetic foot infections.
The biotech released the dismal news this morning, saying that its late-stage OneStep-1 and OneStep-2 trials of Locilex (pexiganan cream), in patients with mild infections of diabetic foot ulcers, missed its primary endpoint of superiority versus vehicle plus standardized wound care.
To make matters worse, it also did “not show any meaningful difference in wound closure rate between the Locilex arm and the vehicle arm in each study.” On top of this, neither trial met the secondary endpoint of gaining a higher rate of eradication of bacteria for the Locilex arm.
There was also higher than anticipated osteomyelitis and cellulitis in the Locilex arm of each study, rounding off a full house of awful news for the co. Its shares? Routed first thing, down 84% before the markets opened and worth just $1.95, down from yesterday’s $12.75.
David Luci, president and CEO of Dipexium, unsurprisingly said that he was “disappointed with these results” but remarkably was still looking for a way forward.
“We are continuing to evaluate the data and will consider potential regulatory pathways forward in other possible clinical indications based on an evaluation of all data emerging from the Phase III studies,” he said in a brief statement this morning.