BioPharmX secures IRB approval to start Phase ll trial of BPX-04

1st August 2018 (Last Updated August 1st, 2018 00:00)

BioPharmX has received approval from the Institutional Review Board (IRB) to begin a PRISM Phase ll trial to examine the safety and efficacy of BPX-04 for the treatment of papulopustular rosacea.

BioPharmX has received approval from the Institutional Review Board (IRB) to begin a PRISM Phase ll trial to examine the safety and efficacy of BPX-04 for the treatment of papulopustular rosacea.

The trial will be based on data from the company’s open-label feasibility study that evaluated the tolerability of BPX-04 topical minocycline gel in subjects with papulopustular rosacea.

Based on the 12-week feasibility study, BioPharmX has selected the 1% minocycline concentration of BPX-04 gel for use in the PRISM trial.

The feasibility study enrolled 30 subjects with moderate-to-severe papulopustular rosacea.

During the study, the subjects received a once-daily administration of either 1%, 2%, or vehicle applied to the face.

"Dermatologists have long desired a new topical antibiotic option that minimises the risks of systemic side effects while not contributing to the bigger issue of systemic antibiotic resistance."

All treatment arms were reported to be well tolerated and no serious adverse events were observed during the trial.

The results further demonstrated the patient-centric benefits of the BioPharmX HyantX delivery system underpinning BPX-04.

The trial's principal investigator Dr Neal Bhatia said: “Optimising delivery to the source of the disease, while minimising the risks of oral antibiotics in patients with rosacea, has the potential to influence better prescribing options for dermatologists.

“Dermatologists have long desired a new topical antibiotic option that minimises the risks of systemic side effects while not contributing to the bigger issue of systemic antibiotic resistance.”

According to the National Rosacea Society, rosacea is a common disorder of the facial skin that affects around 16 million people in the US, many of whom do not even know they have the condition.

The disease is characterised by facial redness, pimples, bumpy breakouts, and thickening of the skin.