BioPharmX Announces Preliminary Data from Rosacea Feasibility Study
Data suggest feasibility of BPX-01 1% and 2% in patients with rosacea
Sep 12, 2017
MENLO PARK, Calif., Sept. 12, 2017 /PRNewswire/ -- BioPharmX Corporation (NYSE MKT: BPMX), a specialty pharmaceutical company focusing on dermatology, is announcing preliminary data from a feasibility study of BPX-01 to assess the safety and efficacy of topical minocycline gel at both the 1% and 2% doses for the treatment of rosacea. The preliminary data from the ongoing study suggest good tolerability and promising efficacy of BPX-01 in this indication and highlight the value of BioPharmX's dermatology delivery system.
This ongoing 12-week, open-label feasibility study to assess the safety and efficacy of BPX-01 topical minocycline gel in rosacea patients enrolled 20 subjects with moderate-to-severe papulopustular rosacea, who applied BPX-01 once daily. Safety was assessed by reviewing treatment emergent adverse events, shifts from baseline in hematology and chemistry laboratory tests as well as cutaneous tolerance scores as assessed both by study subjects and investigators. The preliminary data show that BPX-01 was well tolerated in all subjects treated to date. No adverse events were determined to be treatment related and there were no clinically significant shifts from baseline in hematology and chemistry laboratory tests.
The primary efficacy endpoint from this study is change in Investigator's Global Assessment (IGA) of rosacea at 12 weeks. The secondary efficacy endpoint is change in facial lesion count from baseline at 12 weeks. The preliminary data obtained to date suggest a positive effect on rosacea lesions. Of the 15 subjects that have completed 12 weeks of treatment in the study, 100% have IGA scores of clear (0) or almost clear (1), compared to their baseline scores of moderate (3) or severe (4). Investigators also observed a 93% reduction in total inflammatory lesions from baseline to week 12 in the same subjects who have completed the 12-week study.
"BPX-01 has been well tolerated by the study subjects," said Dr. Neal Bhatia, a board-certified dermatologist at Therapeutics Clinical Research who is the study's principal investigator. "We are pleased with the initial data on efficacy. We look forward to the final results of the study and determining next steps."
Company executives said they expect to pursue additional research to evaluate the efficacy of BPX-01 in rosacea.
"These preliminary results are encouraging and give us guidance as we evaluate our clinical development plan for rosacea. They also reinforce the potential value of our unique drug delivery platform across various dermatology indications," said Anja Krammer, president of BioPharmX. "Additionally, we are excited by the prospect that it may offer rosacea patients a long-overdue therapeutic innovation."
BPX-011 is a hydrophilic (non-oil-based) topical gel with fully solubilized minocycline that has been shown to penetrate the skin to deliver the antibiotic to its target. Following positive results from its previously announced phase 2b study of BPX-01 in acne, BioPharmX continues with phase 3 clinical study plans for BPX-01 for the treatment of acne.
About BioPharmX® Corporation
BioPharmX Corporation (NYSE MKT: BPMX) is a Silicon Valley-based specialty pharmaceutical company, which seeks to provide products through proprietary platform technologies for prescription, over-the-counter (OTC), and supplement applications in the health and wellness markets, including dermatology and women's health. 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, including, but not limited to, statements regarding the safety and medical effects of BPX-01, the effect BPX-01 may have on the treatment of acne and rosacea, the commencement and results of future trials of BPX-01 and the size of such trials, continued and consistent results in future tests of BPX-01 and absence of side effects of future use of BPX-01. These forward-looking statements may be identified by words such as "plan," "expect," "anticipate," "believe" or similar expressions that are intended to identify such forward-looking statements.
These forward-looking statements involve risks and uncertainties, as well as assumptions, which, if they do not fully materialize or prove incorrect, could cause our results to differ materially from those expressed or implied by such forward-looking statements. The risks and uncertainties include those described in the company's filings with the Securities and Exchange Commission, including our annual report on Form 10-K for the period ended Jan. 31, 2017 and our quarterly report on Form 10-Q for the period ended April 30, 2017. Given these risks and uncertainties, you are cautioned not to place undue reliance on such forward-looking statements. 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 or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as may be required under applicable securities law.
BioPharmX is a registered trademark of BioPharmX, Inc.
1Caution: BPX-01 is a new drug limited by U.S. law to investigational use.
SOURCE BioPharmX Corporation
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