BioPharmX has started a phase 2a clinical study under its US FDA Investigational New Drug (IND) application for BPX-01, a hydrophilic formulation of the drug minocycline.
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The company will evaluate effectiveness in decreasing the number of acne-causing bacteria in patients at four weeks and assess the drug’s safety and tolerability.
It is the first clinical study in the clinical development program for BPX-01, which is capable of delivering the antibiotic to the area of the skin where acne develops.
Preliminary animal studies suggest that minocycline delivered by the BPX-01 formulation is absorbed into the skin, reaching the epidermis and the pilosebaceous region where acne develops.
The results indicate that lower doses of the antibiotic may be used to provide a treatment that is superior to higher-dose topical formulations and oral therapies.
BioPharmX executive vice president of research and development Kin Chan said: "We are excited to begin our IND study of BPX-01.
"Our nonclinical research has been well received by the dermatology community."
Minocycline, an antibacterial and anti-inflammatory medicine, is the commonly prescribed acne treatment due to its lower resistance rate when compared to other antibiotics.
BioPharmX offers new healthcare products via its patented platform technologies for pharmaceutical, over-the-counter, and supplement applications.
The company’s products address unmet needs in global markets including dermatology, aesthetics and women’s health.