BioPharmX Receives Concurrence from FDA on Phase 3 Acne Study Plans
Nov 8, 2017
MENLO PARK, Calif., Nov. 8, 2017 /PRNewswire/ -- BioPharmX Corporation (NYSE MKT: BPMX), a specialty pharmaceutical company developing products for the dermatology market, today announces it has received positive feedback from the U.S. Food and Drug Administration (FDA) regarding design of its planned phase 3 clinical trial for BPX-011, the company's topical minocycline gel for the treatment of inflammatory lesions of acne vulgaris.
The company has incorporated feedback from the FDA on key elements of its phase 3 acne program and received clear guidance regarding expectations and requirements for clinical, non-clinical, and chemistry, manufacturing and controls (CMC) needed to support a post phase 3 NDA submission.
Consistent with oral minocycline products, BPX-01 is intended for the targeted treatment of non-nodular inflammatory acne vulgaris. Therefore, BioPharmX believes that an Investigator's Global Assessment (IGA) scale specific to inflammatory lesions is the most appropriate IGA scale to measure treatment success in the co-primary efficacy endpoint as described in the 2005 guidance document for acne product development. The FDA concurred with the company's proposal to use an inflammatory lesion IGA as a co-primary endpoint along with inflammatory lesion reduction.
Topical drug makers typically have not used IGA scales specific to inflammatory or non-inflammatory lesions in their studies. BioPharmX believes that it would be the first company to model its IGA scale for a topical acne product similar to those used by orally administered counterparts. The company further believes use of this modified scale may yield a higher probability for a positive outcome on this critical endpoint.
In what BioPharmX believes to further differentiate its phase 3 acne program from other topical acne programs, the company plans to pursue an intended label indication of treatment of inflammatory lesions of acne vulgaris. An indication specific to inflammatory lesions is consistent with the indication for oral minocycline for acne; and, BPX-01, as a topical product, will result in lower systemic exposure to the antibiotic.
In light of this positive feedback from the FDA, the company continues to consider various options as it finalizes its study design plans and works on additional program requirements needed for an NDA submission. The company is considering strategic partnering alternatives to fund its phase 3 acne clinical trials and expects to begin the trial, should the company raise the necessary capital or upon entering into a strategic partnership to fund the trials.
"We are extremely pleased to reach agreement with the FDA on our proposed endpoints and believe that this could allow the company to move towards a strategic partnership that will fund our phase 3 program and advance our novel topical gel acne product towards commercialization," said Anja Krammer, president of BioPharmX. "We further believe that agreement on these endpoints could help us better achieve positive clinical trial results, and enter the market with a compelling product for the treatment of inflammatory acne."
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 dose range study of BPX-01 in acne, BioPharmX continues with phase 3 clinical study plans for BPX-01 for the treatment of inflammatory lesions 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 strategic partnering alternatives, the safety and medical effects of BPX-01, the effect BPX-01 may have on the treatment of acne, 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, absence of side effects of future use of BPX-01 and ability to advance BPX-01 through a successful NDA submission and commercialization. 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 July 31, 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.
1 Caution: BPX-01 is a new drug limited by U.S. law to investigational use.
SOURCE BioPharmX Corporation
For further information: Nina Brauer, Senior Manager, Marketing & Communications, firstname.lastname@example.org, (650) 889-5030; Investors: email@example.com