Company Anticipates Reporting Topline Efficacy and Safety Results in July 2019
SAN JOSE, Calif., May 22, 2019 /PRNewswire/ -- BioPharmX Corporation (NYSE American: BPMX), a specialty pharmaceutical company focused on developing innovative medical dermatology products, announced today that the last patient in the Company's Phase 2b clinical trial of BPX-041, a novel topical gel formulation of fully solubilized minocycline for the treatment of papulopustular rosacea, has completed their last clinical visit.
"We are pleased to announce this important milestone and look forward to reporting topline results from the study in early July 2019, subject to successful database lock and results validation," said Dr. David S. Tierney, BioPharmX Chief Executive Officer.
The randomized, double-blind, vehicle-controlled study enrolled 206 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.
BPX-04 is a novel topical gel formulation of fully solubilized minocycline for the treatment of papulopustular rosacea. The product candidate leverages the HyantX™ topical delivery system, an anhydrous hydrophilic gel formulation, designed for rapid absorption of active pharmaceutical ingredients into the skin rather than remaining on the surface, a common problem with oil‑based ointments and suspensions.
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.
About BioPharmX® Corporation
BioPharmX Corporation (NYSE American: BPMX) is a specialty pharmaceutical company focused on developing prescription products utilizing its proprietary HyantX Topical Delivery System for dermatology indications. To learn more about BioPharmX, visit www.BioPharmX.com.
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. Additional risks are set forth in our filings with the Securities and Exchange Commission, including those described in the company's Annual Report on Form 10-K for the fiscal year ended January 31, 2019. The forward-looking statements included in this press release are made only as of the date hereof, and the company undertakes no obligation to publicly update such statements.
1Caution: BPX-04 is a new drug limited by U.S. law to investigational use.
BioPharmX and HyantX are registered trademarks of BioPharmX, Inc.
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