New drug promising against uncomplicated malaria in Phase II trial

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In a Phase II non-inferiority trial, a new drug, AQ-13, has demonstrated promise against uncomplicated malaria, presenting a potential new tool for tackling drug-resistant strains.

The findings, published recently in The Lancet Infectious Diseases, are significant as concerns grow around the malarial parasite Plasmodium falciparum becoming resistant to widely-used drugs. The current standard-of-care treatment is a combination therapy of artemether and lumefantrine; however, resistance has been noted in several countries.

This FDA-supervised trial enrolled 66 adult men from two locations in Mali (Africa) who were suffering non-life threatening malaria. The participants were randomized to receive either AQ-13 or the standard artemether and lumefantrine therapy. Participants were monitored for parasite clearance via blood samples and, in the first week of the trial as inpatients, were interviewed for adverse events. Following this was a 5-week follow-up period where individuals were again monitored for adverse events and also signs of recurrent infection.

Comparing the two treatments, the researchers observed that cure rates were similar in both groups (28 [100%] of 28 vs 31 [93·9%] of 33). Five participants from the AQ-13 group were either lost to follow-up, or left the study, in addition, two patients in the control group experienced late treatment failure and recurrence of the malaria infection. Despite this, the results suggested that AQ-13 was not inferior to artemether and lumefantrine.

Senior author, Donald Krogstad, (Tulane University, LA, USA) commented: “The clinical trial results are extraordinarily encouraging. Compared to the current first-line recommendation for treatment of malaria, the new drug comes out very well.”

The team is hoping to expand the trials to test the drug on more participants, including women and children. Krogstad commented that the approach taken to develop this drug may also have implications in uncovering other compounds against resistant parasites, concluding:  “The potential long-term implications are bigger than one drug.

“The conceptual step here is that if you understand the resistance well enough, you may be actually be able to develop others as well. We synthesized over 200 analogues and, of those, 66 worked against the resistant parasites.”

Sources: Koita OA, Sangaré L, Miller HD et al. AQ-13, an investigational antimalarial, versus artemether plus lumefantrine for the treatment of uncomplicated Plasmodium falciparum malaria: a randomised, phase 2, non-inferiority clinical trial. Lancet Inf. Dis. doi:10.1016/S1473-3099(17)30365-1(2017) (Epub ahead of print); https://www.eurekalert.org/pub_releases/2017-09/tu-ntu091217.php

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