MedicalResearch.com Interview with:
Dr. Diana Lac, PhD
Senior Scientist at BioPharmX Corporation.
Dr. Lac received her PhD in Pharmacology and Toxicology from the University of California, Davis and currently focuses on the development of topical treatments for acne.
MedicalResearch: What is the background for this study? What are the main findings?
Dr. Lac: Acne affects almost 90% of people in western societies during their teenage years and may persist into adulthood. Currently, the oral tetracycline class of drugs dominates the acne treatment market. However, these treatments have been associated with a variety of adverse effects, such as headaches, dizziness, fatigue, nausea, photosensitivity, and severe itchiness. While a variety of acne treatments do exist, topical antibiotics particularly have had limited success due to formulation challenges. A topical minocycline formulation will provide a superior alternative for local treatment of acne, thereby limiting the amount of systemic exposure to the antibiotic and addressing the overall global antibiotic resistance problem. We believe that by directly delivering the drug to the skin we can decrease the amount of antibiotic exposure and also limit the off-target effects.
We have developed a novel, stable minocycline gel formulation allowing for efficient delivery of minocycline directly to the pilosebaceous unit in the skin where Propionibacterium acnes typically reside. In this poster presentation we have demonstrated this effectively in live rats. A dose ranging study was conducted where drug delivery and safety of our novel formulation was assessed. A number of dose formulations were tested (up to 4% minocycline formulations) and were found to be non-irritating and safe for topical use.
MedicalResearch: What should clinicians and patients take away from your report?
Dr. Lac: BPX-01, our topical minocycline formulation, is safe, targeted, and can deliver effectively minocycline specifically to the pilosebaceous unit to treat acne. We have demonstrated that at a single application of our formulation, all doses were safe. Through a series of in vitro and in vivo skin uptake studies, we have narrowed our clinical dose to be 1% (or even lower) minocycline. We are confident that at this dose we can deliver effectively minocycline to the skin within the therapeutic levels and further limit the systemic uptake of minocycline.
MedicalResearch: What recommendations do you have for future research as a result of this study?
Dr. Lac: Future studies using repeat dose application in an in vivo system are needed to fully understand our long-term effects. Currently, 4-week and 12-week topical application safety and toxicology studies in different species are underway to further understand the long-term safety aspects of our formulations. This data, in addition to the data presented at ASCB, will help us move our clinical candidate into clinical trials.
Abstract presented at the 2015 ASCB meeting, December 2015