BioPharmX Corporation, a specialty pharmaceutical company in Menlo, Calif., developing products for the dermatology market, will share findings from the first comparative studies of oral and topical minocycline formulations, which detected no traces of minocycline in the bloodstream when it is applied topically. BioPharmX conducted two directional comparative pharmacokinetics (PK) studies of oral minocycline to topical BPX-01.
The comparative studies assessed the impact of a novel topical gel formulation of 1% minocycline and compared it to an extended release oral minocycline to measure skin and plasma concentrations during four-week treatment periods.
Results of a 28-day clinical PK study found no detectable minocycline in skin after two weeks of daily oral treatment with a 1-2 mg/kg dose, but did show minocycline concentrations in the plasma. A separate oral gavage versus BPX-01 minipig study also found minocycline in the plasma for minipigs in the oral group, but no minocycline in the plasma for the topical group. At the same time, the minipig study detected minocycline in the skin of the topical group, but found no minocycline in the skin of the oral group.
BPX-01 is fully solubilized, non-oily, easy-to-use, and capable of being delivered to sebum-rich areas where P. acnes reside.
The research was presented at the Dermatology Education Foundatio DERM2016 NP/PA CME Conference in Las Vegas on Thursday.
“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 Dr. James Q. Del Rosso, of Del Rosso Dermatology Research, Las Vegas. “This provides the potential for avoiding systemic side effects that are known to occur with oral minocycline.”
Acne-causing bacteria have increasingly become resistant to oral antibiotics, which are commonly used to treat moderate-to-severe cases of acne. BPX-01 is expected to deliver a reduced-dose, topical minocycline that provides targeted, localized treatment and limits systemic exposure, thus potentially decreasing dose-dependent side effects and the emergence of antibiotic resistant bacteria.
“The comparative studies’ results are promising because they suggest BPX-01 may mitigate many of the undesirable side effects common to the use of oral minocycline,” said Kin Chan, executive vice president of research and development. “We are optimistic about the continuing studies to further evaluate the safety and efficacy of BPX-01.” BioPharmX expects to begin enrollment of a Phase 2b study of BPX-01 by end of summer.
The American Academy of Dermatology calls acne the “most common skin condition in the United States,” affecting 40 million to 50 million Americans at any given moment. The U.S. market for acne medications is estimated at $10 billion. – PRNewswire