We have completed six Phase 2 clinical programs and multiple pre-clinical programs. Over 1,000 patients have been enrolled in our clinical trials since 2016. All of those patients except for 28 in our open label pediatric study have been enrolled in randomized double-blind placebo controlled clinical trials evaluating both topical and intranasal routes of delivery of AOB with treatment durations ranging from two to 12 weeks. Regardless of dose, mode of delivery, indication targeted, or age of patients, our bacterial drug candidate B244 has been very well tolerated with an adverse event profile that is equal to or less than the vehicle.
The company has selected its lead candidate based upon pre-clinical and clinical results from those trials. The company has recently completed enrollment of 547 patients in a double blind placebo controlled trial for the treatment of adults with pruritus associated with atopic dermatitis in support of its lead program. Other programs, including Phase 3 acne, may be pursued at a later date.
The following diagram shows the current stage of development of our product pipeline: