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Novartis: novel antimalarial is 'game-changing'

Says cipargamin could be first new class of malaria drugs in 20 years

NovartisNovartis has published positive clinical data on what could become the first new class of antimalarial drugs since artemisinins were introduced 20 years ago.

The new agent - called KAE609 or cipargamin - was able to clear malaria parasites from the bodies of infected patients within around 12 hours, and was also effective in people with resistant forms of the disease.

The small study - published in the New England Journal of Medicine - involved 21 patients with malaria from Bangkok and Mae Sot near the Thailand/Burma border, an area which is notorious as a hotbed for the emergence of resistant strains of the parasite.

A single dose of KAE609 was effective against the two main malaria species - Plasmodium falciparum and Plasmodium vivax - and the speed of parasite clearance suggests the drug could be even more effective than artemisinin-derivative therapy.  

It also appeared to be safe and well-tolerated and showed some tantalising effects which suggest it could not only tackle the blood stage infection but also could have transmission-blocking properties. Resistant mutations to the drug have already been identified, however, so it will have to be given as part of a combination regimen.

The profile means KAE609 "is a potential game-changing therapy in the fight against malaria", according to Thierry Diagana, head of the Novartis Institute for Tropical Diseases (NITD) which discovered the drug.

"Novartis has given KAE609 priority project status because of its unique potential of administering it as a single-dose combination therapy," he added, noting that it will shortly enter phase IIb trials.

NITD has also discovered another drug called KAF156 - in the imidazolopiperazine class - whose mechanism is currently unknown but seems to be different from other antimalarial classes and could give it potential as prophylactic for the disease.

The group has also identified a new drug target called P14K that seems to be relevant across the entire lifecycle of the parasite and is in the process of screening drugs to block it.

Resistance spreading
The publication of the results in the NEJM sits alongside another study which clearly shows the pressing need for new drug classes in the battle against malaria, which kills more than 600,000 people a year.

While the treatment of malaria was transformed by the introduction of artemisinin-based combination therapies, artemisinin resistance has emerged in Southeast Asia in the last few years, threatening to derail current control efforts.

Now, researchers have started to quantify the extent of artemisinin resistance and concluded that it is already "firmly established in eastern Myanmar, western Cambodia and Thailand, and southern Vietnam, and is emerging in southern Laos and north-east Cambodia."

While artemisinin-based therapies were still largely effective, the rate of treatment failure is on the rise. For example, there has been a five-fold increase in the failure rate for dihydroartemisinin-piperaquine in Cambodia, they report.  

While welcoming the new antimalarial drug classes coming through development, they point out these will not be available for several years and measures must be taken to stop resistance spreading to India and ultimately Africa, where the majority of malaria-related deaths occur.

Nevertheless, the data on new drug classes is encouraging and comes shortly after GlaxoSmithKline (GSK) filed for approval of RTS,S, the first malaria vaccine which could be available for immunisation programmes in 2016.

While only partially protective against the parasite, the vaccine could have a public health impact when deployed alongside other control strategies such as distribution of mosquito nets and treatment with antimalarial drugs. 

Article by
Phil Taylor

31st July 2014

From: Research

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