- Thinly traded micro cap Dipexium Pharmaceuticals (NASDAQ:DPRX) plunges 85% premarket on robust volume in response to its announcement that both pivotal Phase 3 clinical trials, OneStep-1 and OneStep-2, assessing lead product candidate Locilex (pexiganan cream 0.8%) for the treatment of mild infections of diabetic foot ulcers failed to show superiority over vehicle (placebo) plus standard wound care.
- Locilex also failed to show any meaningful difference in wound closure rate versus vehicle and neither study demonstrated a higher rate of bacteria eradication in the Locilex arm, a secondary endpoint. Adding to the bad news were higher-than-expected serious adverse events in the treatment arm, specifically osteomyelitis (bone infection) and cellulitis (bacterial skin infection).
- CEO David Luci says, "Although we are disappointed with these results, we are continuing to evaluate the data and will consider potential regulatory pathways forward in other possible indications based on an evaluation of all data emerging from the Phase 3 studies."
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Locilex is chemically synthesized 22-amino acid peptide isolated from the skin of the African Clawed Frog. According to the company, it kills microbial targets by disrupting cell membrane permeability. Its value proposition is the (supposed) ability to kill a broad spectrum of Gram-positive, Gram-negative, aerobic and anerobic bacteria as well as fungi. It is formulated as an odorless topical cream.