BioPharmX Corporation’s novel topical minocycline, BPX-01, may be as effective as its oral counterpart minus the systemic side effects, new research suggests.

"These results are promising, that topical minocycline gel delivered as BPX-01, results in local skin levels of minocycline that can be effective in the treatment of acne vulgaris, while simultaneously avoiding systemic exposure based on the absence of plasma levels after topical application," said James Q. Del Rosso, DO, of Del Rosso Dermatology Research in Las Vegas. "This provides the potential for avoiding systemic side effects that are known to occur with oral minocycline."

The research was presented at the Dermatology Education Foundation™ DERM2016 NP/PA CME Conference in Las Vegas. BioPharmX expects to begin enrollment of a Phase 2b study of BPX-01 by end of summer. 

BioPharmX conducted two pharmacokinetics (PK) studies to assess the impact of a 1% minocycline (topical BPX-01) compared to an extended release oral minocycline to measure skin and plasma concentrations during four-week treatment periods. 

There was no detectable minocycline in skin after two weeks of daily oral treatment with a 1-2 mg/kg dose, but there were minocycline concentrations in the plasma after  a 28-day clinical PK study.  A separate oral gavage versus BPX-01 mini-pig study also found minocycline in the plasma for minippigs in the oral group, but no minocycline in the plasma for the topical group.  At the same time, the mini-pig study detected minocycline in the skin of the topical group, but found no minocycline in the skin of the oral group, the studies showed.