23 Mar Development and Assessment of BPX-01, a Novel Topical Minocycline Gel for Treatment of Acne Vulgaris
MedicalResearch.com Interview with:
Usha Nagavarapu, PhD
Senior director of preclinical drug development
BioPharmX
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: Acne vulgaris is a complex chronic inflammatory disease known to be linked with P. acnes and can have profound social and psychological effects. Though a number of treatments exist, there is promise of a long-term benefit for acne patients. BioPharmX’s in vitro and in vivo studies have revealed that a low-dose, topical 1% minocycline gel (BPX-01) provided a localized and targeted delivery of adequate minocycline to the epidermis and pilosebaceous units that can potentially limit systemic exposure and may reduce treatment related side effects.
At the intended clinical dose, toxicity and safety animal studies found that BPX-01 was well tolerated with no significant local or systemic toxic effects. A comparative animal study with oral minocycline demonstrated that topical application of minocycline can limit systemic exposure while delivering sufficient minocycline to the skin to treat acne vulgaris.
Along the same lines, a 4-week clinical study with extended release oral minocycline to assess the skin and plasma concentrations of minocycline was conducted. A marked reduction of mean acne lesion counts from baseline was seen with oral minocycline with presence in plasma. On the contrary no minocycline was identified in the skin from periauricular biopsies.
Recently, BioPharmX completed a 4-week Phase 2 clinical repeat-dose study of BPX-01. The minocycline gel was well tolerated and over 90% of P. acnes were eliminated.
A 12-week Phase 2 dose-finding clinical trial to further assess the efficacy and safety of BPX-01 for the treatment of moderate-to-severe, non-nodular inflammatory acne vulgaris has been initiated. The dose-finding study will provide additional support for the planned Phase 3 clinical trial program with BPX-01.
MedicalResearch.com: What should readers take away from your report?
Response: BPX-01 is a novel topical gel formulation of minocycline for treatment of acne vulgaris that can be delivered to the pilosebaceous units with a favorable safety and efficacy profile compared to oral minocycline.
MedicalResearch.com: What recommendations do you have for future research as a result of this study?
Response: Statistics show that about 80% of people between the ages of 11 and 30 are affected by acne, and in some cases, acne persist into middle age and beyond. According to World Health Organization, skin conditions can reduce quality of life, affecting physical, mental, and social capabilities. Research also implies that about 50% of women have faced adult acne and that the number of adult sufferers is on the rise. Many of the reasons for the exact cause of acne is still not known. A link exists between bacteria such as P.acnes and acne, but there is evidence that suggests that hormones, oil glands and clogged pores also play a role. We believe that treatments for the condition could be further refined.
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Last Updated on March 23, 2017 by Marie Benz MD FAAD