BioPharmX Presents Poster at American Academy of Dermatology Annual Meeting Suggesting BPX-01 Safely, Efficiently Delivers Acne-Fighting Minocycline to Pilosebaceous Units
Drug offers promise to millions of acne sufferers who cannot take oral minocycline
MENLO PARK, Calif., March 2, 2017 /PRNewswire/ -- BioPharmX Corporation (NYSE MKT: BPMX), a specialty pharmaceutical company developing products for the dermatology market, will share early clinical and pre-clinical data at the 2017 American Academy of Dermatology (AAD) Annual Meeting, which will show the company's novel topical gel BPX-01 may deliver acne-fighting medication to a target area without side effects.
A poster sharing the research, titled "Development and Assessment of BPX-01, a Novel Topical Minocycline Gel for Treatment of Acne Vulgaris," will be available for viewing at the event March 3-6. In addition, BioPharmX Senior Director of Preclinical Drug Development Usha Nagavarapu will deliver a presentation based on the poster on March 3 at 10:10 a.m. The AAD meeting, being held in Orlando, Fla., is one of the world's largest gatherings of dermatologists.
Oral minocycline is routinely prescribed for the treatment of acne, but because the drug is delivered systemically, undesirable side effects, such as upset stomach, diarrhea, dizziness and headache often result. BPX-01 is the first topical gel formulation of minocycline, which may enable the use of a much lower dosage of drug, and which clinical and pre-clinical studies suggest thus far does not enter the blood system in measurable quantities.
"The 'Holy Grail' in acne treatment is optimizing both efficacy and tolerability," said Dr. Ted Lain, board certified dermatologist and investigator on the BioPharmX Phase 2b study of BPX-01. "What dermatologists desperately need is a product with both a very limited side effect profile and reliable efficacy comparable to that of oral antibiotics."
BPX-01[1] is the first and only stable hydrophilic (non-oil-based) topical gel with fully solubilized minocycline that can penetrate the skin to deliver the antibiotic to where acne develops in the pilosebaceous unit. The company's studies are designed to confirm whether BPX-01 can effectively treat acne with lower, and potentially safer, dosages of the antibiotic.
"The research to date shows that BPX-01 topical gel may effectively and safely deliver minocycline to target areas," said Kin F. Chan, executive vice president of research and technology at BioPharmX. "The studies so far offer promise to millions of people who cannot take oral minocycline to treat their acne, including the many individuals who are intolerant of systemic antibiotic treatments."
BioPharmX is currently conducting an OPAL (tOPicAL Minocycline Gel) study – a Phase 2b dose finding clinical trial to assess the efficacy and safety of BPX-01 for the treatment of acne vulgaris. The 12-week, multi-center, randomized, double-blind, three-arm, vehicle-controlled study involves 225 individuals, aged 9 to 40, who have moderate-to-severe inflammatory, non-nodular acne vulgaris.
The AAD calls acne the "most common skin condition in the United States," affecting 40 million to 50 million Americans. The U.S. market for prescription acne medications is estimated at $4 billion.
Drug offers promise to millions of acne sufferers who cannot take oral minocycline
MENLO PARK, Calif., March 2, 2017 /PRNewswire/ -- BioPharmX Corporation (NYSE MKT: BPMX), a specialty pharmaceutical company developing products for the dermatology market, will share early clinical and pre-clinical data at the 2017 American Academy of Dermatology (AAD) Annual Meeting, which will show the company's novel topical gel BPX-01 may deliver acne-fighting medication to a target area without side effects.
A poster sharing the research, titled "Development and Assessment of BPX-01, a Novel Topical Minocycline Gel for Treatment of Acne Vulgaris," will be available for viewing at the event March 3-6. In addition, BioPharmX Senior Director of Preclinical Drug Development Usha Nagavarapu will deliver a presentation based on the poster on March 3 at 10:10 a.m. The AAD meeting, being held in Orlando, Fla., is one of the world's largest gatherings of dermatologists.
Oral minocycline is routinely prescribed for the treatment of acne, but because the drug is delivered systemically, undesirable side effects, such as upset stomach, diarrhea, dizziness and headache often result. BPX-01 is the first topical gel formulation of minocycline, which may enable the use of a much lower dosage of drug, and which clinical and pre-clinical studies suggest thus far does not enter the blood system in measurable quantities.
"The 'Holy Grail' in acne treatment is optimizing both efficacy and tolerability," said Dr. Ted Lain, board certified dermatologist and investigator on the BioPharmX Phase 2b study of BPX-01. "What dermatologists desperately need is a product with both a very limited side effect profile and reliable efficacy comparable to that of oral antibiotics."
BPX-01[1] is the first and only stable hydrophilic (non-oil-based) topical gel with fully solubilized minocycline that can penetrate the skin to deliver the antibiotic to where acne develops in the pilosebaceous unit. The company's studies are designed to confirm whether BPX-01 can effectively treat acne with lower, and potentially safer, dosages of the antibiotic.
"The research to date shows that BPX-01 topical gel may effectively and safely deliver minocycline to target areas," said Kin F. Chan, executive vice president of research and technology at BioPharmX. "The studies so far offer promise to millions of people who cannot take oral minocycline to treat their acne, including the many individuals who are intolerant of systemic antibiotic treatments."
BioPharmX is currently conducting an OPAL (tOPicAL Minocycline Gel) study – a Phase 2b dose finding clinical trial to assess the efficacy and safety of BPX-01 for the treatment of acne vulgaris. The 12-week, multi-center, randomized, double-blind, three-arm, vehicle-controlled study involves 225 individuals, aged 9 to 40, who have moderate-to-severe inflammatory, non-nodular acne vulgaris.
The AAD calls acne the "most common skin condition in the United States," affecting 40 million to 50 million Americans. The U.S. market for prescription acne medications is estimated at $4 billion.
