BioPharmX Announces Positive Topline Phase 2a Clinical Trial Results for BPX-01
- No detectable minocycline uptake in patients' bloodstreams
- Statistically significant reduction in P. acnes bacteria after only four weeks of once daily topical treatment
- No reports of cutaneous toxicity or skin intolerance
MENLO PARK, Calif., June 29, 2016 /PRNewswire/ -- BioPharmX Corporation (NYSE MKT: BPMX), a specialty pharmaceutical company developing products for the dermatology market, today announced topline results from its Phase 2a safety study of BPX-01, a unique topical gel formulation of minocycline.
Results from the first human trial of BPX-01 showed the product reported no cutaneous toxicity, resulted in no adverse effects, and found no detectable levels of minocycline in the patients' bloodstreams.
"The findings confirm the data from preclinical studies of BPX-01 and reaffirm our belief that BPX-01 has the potential to revolutionize the way dermatologists treat acne with safer, more effective topical therapy," said Anja Krammer, president and co-founder of BioPharmX. "These positive Phase 2a results allow us to proceed with next phase clinical studies with BPX-01 and we are optimistic that the planned Phase 2b study will further confirm the value of this product."
The company chose minocycline because it is the antibacterial and anti-inflammatory medicine most commonly prescribed to treat acne vulgaris. The BPX-01 formulation of minocycline can penetrate the skin to deliver the antibiotic to the layer of skin where the acne develops in the pilosebaceous unit. BPX-01 is the first and only stable hydrophilic (non-oil-based) topical gel with fully solubilized minocycline. The company's studies are designed to confirm whether BPX-01 will effectively treat acne with lower, safer dosages of the antibiotic.
While all the Phase 2a results were positive, the finding that stood out most was the absence of detectable minocycline in the plasma of subjects receiving BPX-01. When taken orally, the amount of minocycline found in the bloodstream is typically thousands of ng/ml, which are often associated with significant systemic toxicity that cause undesirable side effects. These Phase 2a study results suggest that a much lower dose of minocycline applied topically has the potential to effectively treat acne without the side effects normally associated with the oral form of the antibiotic.
The randomized study involved 30 subjects who underwent once daily treatment with BPX-01 1% minocycline topical gel or a vehicle control. The study's other specific findings included:
No cutaneous toxicity was reported by investigator or subjects.
No drug-related adverse events were reported.
A statistically significant reduction in P. acnes bacteria was observed after four weeks of once-daily BPX-01 treatment, compared to baseline.
Patient exit survey indicated 100% satisfaction with usability and tolerability
"These topline results are extremely exciting to the dermatology community because the current standard of care for acne often exposes patients to systemic antibiotics," said Dr. Hilary Baldwin, a board-certified dermatologist with nearly 25 of years of experience, who is co-chair of the BioPharmX Therapeutic Dermatology Medical Advisory Board. "Initial studies suggest that BPX-01 will be a highly effective topical treatment for acne with virtually none of the side effects associated with oral minocycline."
The American Academy of Dermatology calls acne the "most common skin condition in the United States," affecting 40 million to 50 million Americans. The U.S. market for acne medications is estimated at $10 billion.
BioPharmX expects to begin enrollment of its Phase 2b study by end of summer.
- No detectable minocycline uptake in patients' bloodstreams
- Statistically significant reduction in P. acnes bacteria after only four weeks of once daily topical treatment
- No reports of cutaneous toxicity or skin intolerance
MENLO PARK, Calif., June 29, 2016 /PRNewswire/ -- BioPharmX Corporation (NYSE MKT: BPMX), a specialty pharmaceutical company developing products for the dermatology market, today announced topline results from its Phase 2a safety study of BPX-01, a unique topical gel formulation of minocycline.
Results from the first human trial of BPX-01 showed the product reported no cutaneous toxicity, resulted in no adverse effects, and found no detectable levels of minocycline in the patients' bloodstreams.
"The findings confirm the data from preclinical studies of BPX-01 and reaffirm our belief that BPX-01 has the potential to revolutionize the way dermatologists treat acne with safer, more effective topical therapy," said Anja Krammer, president and co-founder of BioPharmX. "These positive Phase 2a results allow us to proceed with next phase clinical studies with BPX-01 and we are optimistic that the planned Phase 2b study will further confirm the value of this product."
The company chose minocycline because it is the antibacterial and anti-inflammatory medicine most commonly prescribed to treat acne vulgaris. The BPX-01 formulation of minocycline can penetrate the skin to deliver the antibiotic to the layer of skin where the acne develops in the pilosebaceous unit. BPX-01 is the first and only stable hydrophilic (non-oil-based) topical gel with fully solubilized minocycline. The company's studies are designed to confirm whether BPX-01 will effectively treat acne with lower, safer dosages of the antibiotic.
While all the Phase 2a results were positive, the finding that stood out most was the absence of detectable minocycline in the plasma of subjects receiving BPX-01. When taken orally, the amount of minocycline found in the bloodstream is typically thousands of ng/ml, which are often associated with significant systemic toxicity that cause undesirable side effects. These Phase 2a study results suggest that a much lower dose of minocycline applied topically has the potential to effectively treat acne without the side effects normally associated with the oral form of the antibiotic.
The randomized study involved 30 subjects who underwent once daily treatment with BPX-01 1% minocycline topical gel or a vehicle control. The study's other specific findings included:
No cutaneous toxicity was reported by investigator or subjects.
No drug-related adverse events were reported.
A statistically significant reduction in P. acnes bacteria was observed after four weeks of once-daily BPX-01 treatment, compared to baseline.
Patient exit survey indicated 100% satisfaction with usability and tolerability
"These topline results are extremely exciting to the dermatology community because the current standard of care for acne often exposes patients to systemic antibiotics," said Dr. Hilary Baldwin, a board-certified dermatologist with nearly 25 of years of experience, who is co-chair of the BioPharmX Therapeutic Dermatology Medical Advisory Board. "Initial studies suggest that BPX-01 will be a highly effective topical treatment for acne with virtually none of the side effects associated with oral minocycline."
The American Academy of Dermatology calls acne the "most common skin condition in the United States," affecting 40 million to 50 million Americans. The U.S. market for acne medications is estimated at $10 billion.
BioPharmX expects to begin enrollment of its Phase 2b study by end of summer.
