Open-label feasibility study results identify BPX-04 topical minocycline gel, 1% as optimal dose for phase 2 trial
MENLO PARK, Calif., July 31, 2018 /PRNewswire/ -- BioPharmX Corporation (NYSE American: BPMX), a specialty pharmaceutical company developing products for the dermatology market, today announced it has received Institutional Review Board approval for its phase 2 study of BPX-04 for the treatment of papulopustular rosacea.
The company also announced that, based on data from its open-label feasibility study which assessed tolerability in subjects with papulopustular rosacea, it has selected the 1% minocycline concentration for use in the PRISM phase 2 trial to evaluate the safety and efficacy of BPX-04, continuing in its patient-centric commitment to antibiotic stewardship by utilizing a lower dose of antibiotics for patients.
The 12-week, open-label feasibility study assessed the tolerability of BPX-04 topical minocycline gel in 30 subjects with moderate-to-severe papulopustular rosacea. Once-daily administration of either 1%, 2%, or vehicle was applied to the face. All treatment arms were well tolerated and there were no serious adverse events, further demonstrating the patient-centric benefits of the BioPharmX HyantX™ delivery system underpinning BPX-04.
"Optimizing delivery to the source of the disease, while minimizing the risks of oral antibiotics in patients with rosacea, has the potential to influence better prescribing options for dermatologists," said Dr. Neal Bhatia, a board-certified dermatologist at Therapeutics Clinical Research in San Diego and the study's principal investigator. "Dermatologists have long desired a new topical antibiotic option that minimizes the risks of systemic side effects while not contributing to the bigger issue of systemic antibiotic resistance."
Dr. Bhatia highlighted BPX-04 data at the recent American Academy of Dermatology Summer Meeting in a presentation called "Therapeutic Update" in Chicago. Long-term safety and efficacy, as well as treatment strategies with these new regimens were also discussed.
The National Rosacea Society describes rosacea as a common, but poorly understood disorder of the facial skin that affects an estimated 16 million Americans, many of whom do not even know they have the condition. Rosacea is characterized by facial redness, pimples, bumpy breakouts, and thickening of the skin.
BPX-041 is the company's second candidate utilizing the novel, patented HyantX™ delivery system, which is designed to stabilize and solubilize hydrophilic molecules in an anhydrous gel environment. This delivery system is being developed to carry a variety of active ingredients – and even combinations of actives – into the skin. Research has shown the delivery system may allow for maximum solubility for multiple actives, which is intended to lead to enhanced skin penetration and increased efficacy and tolerability, has antibacterial properties, and hydrates the skin, making the delivery system a valuable asset in pipeline development and strategic partnering.
This press release contains forward-looking statements related to the company's plans or developments that involve risks, uncertainties and assumptions, and are subject to the "safe harbor" of the Private Securities Litigation Reform Act of 1995. These statements may be identified by words such as "plan," "expect," "believe," "intend," "should," "may" or similar expressions. Important factors that could cause actual results to differ materially than those expressed or implied in such statements include, but are not limited to, the commencement and results of future trials of BPX-04 and the size of such trials, the safety and medical effects of BPX-04, the effect BPX-04 may have on the treatment of rosacea, absence of side effects of future use of BPX-04 and ability to advance BPX-04 through a successful NDA submission and commercialization. Additional risks are set forth in our filings with the Securities and Exchange Commission, including those described in the company's Quarterly Report on Form 10-Q for the most recent fiscal quarter. The forward-looking statements included in this news release are made only as of the date hereof, and the company undertakes no obligation to publicly update such statements.BioPharmX is a registered trademark of BioPharmX, Inc.
1Caution: BPX-04 is a new drug limited by U.S. law to investigational use.