May I remind you,
Our portfolio of product candidates includes three clinical-stage drug product candidates, BPX01, a topical antibiotic for the treatment of acne, BPX04, a topical antibiotic for the treatment of rosacea, and BPX03, a molecular iodine tablet for the treatment of moderate to severe, periodic breast pain associated with fibrocystic breast condition, or FBC, and cyclic mastalgia. In addition, we have initiated a pre-Phase 2 feasibility study for BPX04, a topical antibiotic for the treatment of rosacea.
We presented comprehensive BPX01 Phase 2b clinical data for the treatment of acne and received positive FDA feedback regarding our BPX01 Phase 3 clinical study plans. We are considering strategic partnership alternatives to fund our Phase 3 clinical program in this indication. We expect to begin the Phase 3 clinical trial, should we raise the necessary additional capital or upon entering into a strategic partnership to fund the trial. We have initated a pre-Phase 2 feasibility study of BPX04 for the treatment of rosacea. An interim analysis of the 17 subjects who have completed the 12-week study suggest good tolerability and promising efficacy of BPX04 for this indication.
We initiated a 20 person pre-Phase 2 feasibility study of BPX04 for the treatment of rosacea. We expect to complete this study later this year, after which we would initiate a Phase 2 dose-ranging study.
BPX01 and BPX04 are a topical formulations of minocycline (Solodyn), a previously approved oral antibiotic. Reliance on safety findings made by the FDA in approving Solodyn, the antibiotic we will reference in our NDA, could expedite the development program for our product candidates by decreasing the amount of preclinical or clinical data that we would need to generate in order to obtain FDA approval.
For some of our product candidates, we may in the future determine to collaborate with pharmaceutical and biotechnology companies for development of products. In particular, a part of our strategy is to seek to enter into enter into a strategic collaboration to fund the continued development of BPX01.
Note, All information above including Risk Factors can be found in the Dec. 12, 2017, 10-Q filing.
