The Menlo Park, CA-based specialty pharmaceutical company brought together a panel of dermatologists and company executives on June 1 to share with investors insight about the findings of its phase 2b acne study for BPX-01, billed as the first completely solubilized topical minocycline gel product candidate for the treatment of moderate-to-severe acne. The hydrophilic topical gel with fully solubilized minocycline penetrates the skin to deliver the antibiotic to where acne develops in the pilosebaceous unit, according to BioPharmX.
Dr. Baldwin was joined on the panel by Dr. James Leyden, professor emeritus of dermatology, the University of Pennsylvania; Dr. Ted Lain, Austin Institute for Clinical Research (Austin, TX); Dr. Andrew Alexis, chairman, department of dermatology director, Skin of Color Center, Mount Sinai St. Luke’s and Mount Sinai West; and Dr. Neal Bhatia, director of clinical dermatology, Therapeutics Clinical Research.
Dr. Baldwin discussed the burden of acne, starting off with a look at the number of patients in the US. Citing 50 million Americans who have acne, she suggested that the rates of skin disorder are probably higher, especially when factoring in teenagers.
“I think we actually hit 100% with teenagers. If you have one or two pimples or more, then yes, you have acne,” Dr. Baldwin said.
Dr. Baldwin also addressed acne in adult females, those in their 20s, 30s and 40s.
She asked the audience if acne was more common today in among adult women then it was before. Answering her own question, she said that while that could be the case, more women could be coming in for treatment because they see more treatments available today.
In fact, the average acne patient is being treated with 2.53 acne medications, according to Dr. Baldwin. “We pick and choose from what’s at our disposal to come up with a cocktail,” she said, noting the combination of topical, oral and physical modalities that are used. She also addressed the issues that come from each, such as length of time it takes to see results and irritation, side effects of oral medications and the cost and temporary results that might come from lasers, light therapies or other acne surgeries.
Dr. Baldwin also talked about benzoyl peroxide, the industry workhorse. Although it remains a go-to treatment with decades of usage behind it, this ingredient still has some issues—irritation, as well as bleaching and discoloration of fabric. She told attendees while the latter might seem frivolous, it can impact patient compliance.
Here’s Dr. Baldwin’s list for a treatment: doesn’t cause skin irritation, works rapidly, is used once a day, is cosmetically elegant, doesn’t cause bleaching and staining and is also anti-inflammatory.
“We are still searching for the Holy Grail,” she said.
A dermatologist who has played a major role in advancing acne treatments towards, Dr. Leyden discussed minocycline. He knows the drug well, having been involved in the drug’s initial development as an acne treatment in the 1970s. Prior to that, it was used to treat prostate issues.
“We found it be highly effective in treating really bad acne,” Dr. Leyden said.
According to Dr. Leyden, companies have tried and failed to create a topical minocycline treatment, but he has high hopes for BPX-01.
“Dermatologists are ready for this,” he told those gathered at the investor symposium, which was held at the W Hotel in midtown New York City.
According to BioPharmX, it achieved the primary endpoint in its phase 2b clinical trial.
From the topline results for the study's primary endpoint, BioPharmX observed in both the 1% and 2% doses of BPX-01 statistically significant reductions in non-nodular inflammatory acne lesions when compared to vehicle. The phase 2b study was a randomized, double-blind, three-arm, vehicle-controlled dose-finding study to assess the efficacy and safety of BPX-01 for the treatment of acne vulgaris. The multi-center study evaluated two concentrations of BPX-01 (1% and 2% minocycline) and vehicle in 226 subjects, aged 9 to 40, with moderate-to-severe inflammatory, non-nodular acne vulgaris. The phase 2b study also measured reduction in Investigator's Global Assessment (IGA) as a secondary endpoint, which was defined as the proportion of subjects with at least a two-grade reduction in IGA to clear or almost clear. Based on these phase 2b results, BioPharmX say it continues to progress BPX-01 toward a phase 3 program.
"These results represent a major milestone for the company and offer the potential of BPX-01 as the first topical gel minocycline for moderate-to-severe acne, optimizing safety and efficacy of a proven antibiotic for this condition to millions of patients," said Anja Krammer, co-founder and president of BioPharmX.
The success of this drug doesn’t necessarily mean for treatments like benzoyl peroxide, which dermatologists consider a workhorse.
Dr. Lain, one of the key investigators in the study of BPX-01, told symposium attendees that the treatment appeared to be efficacious, well tolerated and suggested it would be a welcome addition to a derm’s tool kit.
“This drug will play well with others,” he said.