A Special Protocol Assessment has been completed with the US Food and Drug Administration (FDA) for the pivotal Phase III study of Immtech International's oral drug candidate, DB289, for the treatment of Pneumocystis pneumonia (PCP) in patients with HIV/AIDS.
The randomized, double-blind trial will evaluate the efficacy, safety and tolerability of DB289, when administered as 100 mg tablets twice daily for 14 days versus the standard of care, which is trimethoprim-sulfamethoxazole (TMP-SMX) tablets, administered three times a day for 3 weeks.
The study is expected to involve approximately 270 patients in the US, Mexico, Colombia, Peru, Chile and Argentina. Patients will be evaluated for clinical success on Day 22 of the study. They will have an additional evaluation 42 days after initiation of treatment to determine sustained
clinical success.
Carol Olson, Vice President and Chief Medical Officer, said, "We are pleased that the FDA has completed the Special Protocol Assessment, and we can initiate our pivotal trial in PCP. PCP is the most common opportunistic infection in patients with AIDS, and is a significant cause of morbidity and mortality globally. DB289 is a potential first-line alternative to TMP-SMX for treatment of PCP, as a significant number of patients are intolerant of TMP-SMX, and other currently available treatments are considered to be second line. In addition, DB289 will significantly decrease the daily pill burden for the patients who take treatment for PCP."
The development of DB289 for the treatment of PCP was sponsored in part by a National Cooperative Drug Discovery Groups (NCDDG) grant from the National Institutes of Health, US Department of Human Health and Services, to the University of North Carolina at Chapel Hill. DB289 was initially synthesized at Georgia State University. Immtech is developing DB289 for use in PCP, African sleeping sickness (trypanosomiasis), and malaria.