The U.S. portion of the currently ongoing 450 patient global Phase 2b study for NVC-422 in adenoviral conjunctivitis launched in May, and recruitment is running ahead of schedule. Indian enrollment is expected to begin this month, with Brazilian enrollment expected in January of 2013. The recent financing will enable NovaBay to accelerate this global Phase 2b study through the expansion of the number of clinical sites. The Company expects to report global trial results in the second half of 2013.
The recent financing also provides NovaBay with the resources to conduct a Phase 2 study of NVC-422 as a treatment for bacterial conjunctivitis, facilitating NovaBay's ultimate goal of one product capable of treating both viral and bacterial conjunctivitis.
NovaBay's development focus in dermatology is to support the ongoing Phase 2b global clinical trial for impetigo, a highly contagious skin infection that mainly affects children. The study is being conducted by NovaBay's partner Galderma S.A., a world-leading pharmaceutical company for the treatment of dermatological conditions.In June 2012, NovaBay announced a successful End-of-Phase 2a meeting with the U.S. Food and Drug Administration (FDA), who provided valuable protocol guidance for the design of the Phase 2b study that started in September. Also in September, Galderma paid NovaBay $2.6 million in a previously agreed upon milestone payment, in addition to ongoing research and development funding. As previously stated, Galderma expects to report Phase 2b clinical data for the impetigo study in mid 2013. Urology NovaBay's development focus in urology is to use the confirmed antimicrobial properties of NVC-422 to develop a urinary catheter irrigation solution for the poorly served 330,000 chronically catheterized patients who suffer from urinary catheter blockage and encrustation (UCBE). Current standard of care for these patients involves flushing their catheters three times daily. Results have demonstrated that NVC-422 Irrigation Solution reduces the need to flush catheters to only two to three times weekly, significantly improving patient quality of life. The ongoing Phase 2 Proof of Concept clinical trial for the use of NVC-422 in the treatment of UCBE continues at a steady pace, with data expected in the first half of 2013.