A completed a special protocol documents the FDA’s agreement that the design and planned analysis of the Study adequately addresses objectives in support of a regulatory submission such as a New Drug Application (NDA).
The randomized, open-label trial will evaluate the efficacy of DB289, when administered as 100mg tablets twice daily for ten days versus the standard of care, which is pentamidine given intramuscularly once a day for seven days.
The study is expected to involve 250 patients in the Democratic Republic of the Congo, Sudan and Angola, and will include pregnant and nursing women, and adolescents 12 years and older. Patients will be examined at the end of the treatment period for clearance of trypanosome parasites from blood, lymph nodes and cerebrospinal fluid, and have post-treatment follow-up evaluations.
Stephen Thompson, president and CEO said, “We are delighted that the FDA has completed the completed a special protocol, and we can initiate our pivotal trial in African Sleeping Sickness, in addition to our ongoing trials in malaria and Pneumocystis pneumonia (PCP). We are focused on developing DB289 to cure devastating diseases that affect billions of people globally.”