Drug Development, Setbacks

Dipexium shares eviscerated after lead antibiotic flops on a full slate of PhIII endpoints

Benjamin A. Lipsky, Dipexium

Benjamin A. Lipsky, Dipexium

The microcap biotech Dipexium Pharmaceuticals $DPRX went public in 2014, promising to advance an important new antibiotic cream in the clinic. But today, the little biotech was forced to concede that their lead program flopped badly in two late-stage studies, flunking the primary as well as secondary endpoints.

Not only was there no “meaningful difference” between their antibiotic and standard care for wound closure rates among patients with diabetic foot ulcers, it also wasn’t able to eradicate bacteria significantly better. Adding insult to injury, the company added that “serious adverse events with Locilex included higher than anticipated osteomyelitis and cellulitis in the Locilex arm of each study.”

The news eviscerated its share price, which plunged 85% in pre-market trading.

Dipexium picked up the rights to Locilex from Magainin Pharmaceuticals, which tried and failed to win an FDA approval in 1999. The Dipexium crew reformulated the treatment and then touted the FDA’s willingness to approve the drug on a placebo controlled Phase III program.

But none of that made any difference at all.

The New York-based biotech started the day with a market cap of $132 million and went public at $12 a share. It closed yesterday at $12.75.

Benjamin A. Lipsky, the chairman of the Phase III program, put the most optimistic face on this as possible:

The results of this study will provide important information regardless of the outcome. This will include a better understanding of the natural course of diabetic foot ulcer and infection, and a recognition that some Mild DFI patients may not need antibacterial treatment.  The exemplary conduct of the trial reflects extremely well on the participating investigators. We look forward to continuing analyses of the wealth of data accumulated and to report more details of our findings.

“The OneStep trials were the first ever ‘placebo’-controlled studies conducted for mildly infected diabetic foot ulcers,” said Dipexium Executive Chairman Robert J. DeLuccia in a statement. “In these studies, the ‘placebo’ was the cream vehicle without pexiganan, the active pharmaceutical ingredient in Locilex. These complex trials required stringent standardized wound care, in both study arms, including ulcer debridement, daily wound dressing changes and pressure off-loading devices. Since antibiotics are generally used by clinicians to treat an infected ulcer, no clinical trial in diabetic foot infection has ever established a ‘response rate’ for an ulcer infection that had standardized wound care but was untreated with an antibiotic.”

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