Company anticipates announcing topline efficacy and safety results in July 2019
SAN JOSE, Calif. /PRNewswire/ -- BioPharmX Corporation (NYSE American: BPMX), a specialty pharmaceutical company focused on developing innovative medical dermatology products, today announced that it has completed enrollment of its Phase 2b clinical trial with BPX-041, a novel topical gel formulation of fully solubilized minocycline for the treatment of papulopustular rosacea.
"This is an important milestone for our rosacea program and we look forward to reporting topline results from the study later this year," said David Tierney, BioPharmX CEO. "Unlike currently available therapies which may further irritate a patient's already sensitive skin, BPX-04—which utilizes our proprietary HyantX topical delivery system—was designed to improve the bioavailability of solubilized minocycline and enable a more targeted delivery to minimize irritation. Based on results from earlier studies, we believe that BPX-04 may provide an effective treatment for rosacea while minimizing the unwanted adverse effects associated with oral forms of antibiotics, as well as the tolerability limitations of topical treatments, thereby addressing an unmet need for 16 million patients in the US alone."
Rosacea is a chronic dermatologic condition characterized by redness, stinging and inflammatory lesions primarily on the face. The biology of rosacea remains unclear, however it is thought to be an inflammatory disorder that involves immune responses and microorganisms. Rosacea is estimated to affect more than 16 million people in the United States alone, according to the National Rosacea Society. Current treatment options, while limited, include oral antibiotics, anti-parasitics, azelaic acids and alpha-A agonists.
The randomized, double-blind, vehicle-controlled study enrolled 207 subjects with moderate-to-severe papulopustular rosacea. The multicenter study is evaluating the safety and efficacy of once daily application of BPX-04, a 1% minocycline gel, versus a vehicle control over a 12-week treatment period. The study's primary endpoint is the mean change in the number of facial inflammatory lesions of rosacea from baseline to week 12.
The information in this press release contains forward-looking statements and information within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, which are subject to the "safe harbor" created by those sections. This press release contains forward-looking statements about the company's expectations, plans, intentions, and strategies, including, but not limited to the timing for the announcement of topline results for the study, 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.
1 Caution: BPX-04 is a new drug limited by U.S. law to investigational use.