Immtech completes FDA Special Protocol Assessment for DB289 AIDS pneumonia drug

By Ted A. Knutson

Washington, March 6 - Immtech International, Inc. said Monday that a Special Protocol Assessment has been completed with the Food and Drug Administration for the pivotal phase 3 study of DB289 for the treatment of pneumocystis pneumonia in patients with HIV/AIDS.

A Special Protocol Assessment 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.

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 three weeks.

The study is expected to involve about 270 patients in the United States, 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 the start of treatment to determine sustained clinical success.

"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 [pneumocystis pneumonia], 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 [pneumocystis pneumonia]," said Carol Olson, MD, Ph.D, Immtech vice president and chief medical officer, in a press release.

The development of DB289 for the treatment of PCP was sponsored in part by a National Cooperative Drug Discovery Groups grant from the National Institutes of Health to the University of North Carolina at Chapel Hill. DB289 was initially synthesized at Georgia State University.

Immtech is developing DB289 for use in pneumocystis pneumonia, African sleeping sickness (trypanosomiasis) and malaria.

Immtech International is a Vernon Hills, Ill.-based pharmaceutical company developing and commercializing drugs to treat infectious diseases.

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