BioPharmX is developing a novel, proprietary topical minocycline gel formulation (BPX-01) for the treatment of acne vulgaris. The product is the first candidate from our anhydrous hydrophilic topical delivery system and in our formulation, the minocycline is completely solubilized. Our formulation is currently in clinical development for patients with moderate-to-severe acne.
BPX-01 utilizes minocycline that is solubilized and stable in a vehicle that is hydrophilic and capable of penetrating into the region of the skin where P. acnes reside. Compared to lipophilic ointments and suspensions, which can be oily to the touch and leave residue, the hydrophilic BPX-01 is rapidly absorbed into the skin rather than remaining on the surface and has many benefits such as high bioavailability, ease of application, non-irritating and non-fluorescing. BioPharmX scientists have conducted extensive in vitro and in vivo studies demonstrating selective delivery of minocycline to the epidermis and the pilosebaceous unit.
In a phase 2a clinical study, BPX-01 demonstrated a statistically significant reduction in facial P. acnes after four weeks of once-daily treatment with no measurable systemic levels of minocycline and no drug-related adverse effects. Based on these observations and the promising preclinical data, the company conducted a phase 2b dose-ranging study to evaluate the safety and efficacy of two different concentrations of BPX-01 compared to vehicle in patients with moderate-to-severe acne. Topline results from the phase 2b study showed statistical significance in our primary endpoint of inflammatory acne lesion reduction compared to vehicle and while not statistically significant, a clear numerical trend in the Investigator’s Global Assessment (IGA) score for our secondary endpoint of a two-grade improvement improvement to clear or almost clear.
Preclinical studies with BPX-01 did not result in measurable systemic exposure or any undesirable cutaneous side effects. This profile supports the continued research to develop BPX-01 as the first potential topical gel formulation of minocycline.
SAFETY – Orally administered minocycline can have undesirable systemic side effects. By repurposing minocycline as a topical gel, the antibiotic is administered to the site of the P. acnes infection in a more targeted manner reducing side effects.
ACNE – The American Academy of Dermatology calls acne “the most common skin condition in the United States,” affecting 40 million to 50 million Americans, with approximately 15 million suffering from moderate-to-severe acne. According to SSR Health, the U.S. market for prescription acne medications was estimated at nearly $4 billion in 2016.