The Phase 2a study will assess the safety of BPX-01 in 30 patients randomized to 30 days of treatment with either BPX-01 or a placebo. The endpoints of this study include reduction of Propionibacterium acnes (P. acnes) and cutaneous tolerance of the BPX-01 formulation.
"This research is important to the dermatology community, which has been searching for an effective alternative to current oral antibiotic acne treatments," said AnnaMarie Daniels, executive vice president of clinical and regulatory affairs for BioPharmX.
"Our preclinical tests show the potential of BPX-01, which we believe may be able to offer dermatologists a safe, effective treatment for one of the most common skin conditions in the world."
Nonclinical studies show the unique BPX-01 topical gel formulation of minocycline can penetrate the epidermis to deliver the antibiotic to the dermis layer of skin where the condition develops.
BPX-01 is the first and only stable hydrophilic (non-oil-based) topical gel with fully solubilized minocycline, the antibacterial and anti-inflammatory medicine most commonly prescribed to treat acne vulgaris. It is anticipated that BPX-01 may effectively treat acne with lower, and therefore potentially safer, dosages of the antibiotic.
The FDA has previously found oral minocycline to be safe. However, the high dosage required to make the oral version effective against acne often causes undesirable side effects. BPX-01 is highly anticipated by the dermatology community as a break-through alternative to the oral products currently available.
Phase 2a is expected to end by mid-year.