Novartis begins human testing of new anti-malaria drug

Novartis AG is taking aim at drug-resistant malaria - a growing global problem – having launched clinical trials of the first new antimalarial medicine for many years in nine countries across Africa and Asia.

The Swiss drugmaker is advancing development of an alternative to its current treatment that billionaire philanthropist Bill Gates said risked losing potency. It is working on the mid-stage Phase IIb trial programme with the group Medicines for Malaria Venture (MMV), said today it believed its drug KAF156 could be a "game-changer".

Patients in Mali infected with the mosquito-borne parasite have begun receiving the experimental drug, known as KAF156, in combination with another medicine, the drugmaker said. More than 500 children and adults across nine countries in Africa and Asia will be enrolled in the mid-stage study over the next few months.

The research, being conducted with the Medicines for Malaria Venture, aims to determine the most effective and tolerable dose, and ultimately fill the need for a novel treatment to stave off the development of drug-resistance.

Strains of the Plasmodium falciparum parasite that evade artemisinin, the most potent malaria-killer, have been detected in five Asian countries and risk taking hold in Africa, where there have been sporadic reports of reduced sensitivity to artemisinin-based therapies, said Vas Narasimhan, global head of drug development at Basel, Switzerland-based Novartis.

Initial tests suggest KAF156 has the potential to rapidly clear malaria infection, including resistant strains, as well as to block the transmission of the mosquito-borne malaria parasite.

KAF156 belongs to a novel class of antimalarial compounds called imidazolopiperazines. It is designed to be used in combination with an improved formulation of the existing antimalarial lumefantrine.

The new clinical trial programme now under way at one centre in Mali will be followed by 16 additional centres across a total of nine countries in Africa and Asia over the next few months.

"To build on the gains made against malaria since the turn of the century, we need new medicines that are effective across all types of resistance patterns and geographies, and that are easy to administer, especially to children," said Dr David Reddy, chief executive of MMV.

Deaths from malaria have fallen sharply since 2000, thanks to the roll-out of insecticide-treated bednets, but the World Health Organisation estimates there were still 438,000 fatal cases in 2015, most the them in African children.

''The fact that we are already able to find parasites that are starting to show resistance is a cause for concern,'' Narasimhan told Bloomberg in an interview. ''We have to get ahead of this now because we wouldn't want to be in a situation where we lose one of those medicines to resistance on a large scale.''

Malaria kills a child every two minutes, according to the World Health Organization. A steady decline over the past decade in the global malaria death toll - which was 429,000 in 2015 - risks reversing if a mutant form of P. falciparum resistant to artemisinin continues to spread beyond Cambodia, Laos, Myanmar, Thailand and Vietnam, helped by poor treatment practices and inadequate compliance.

The company's KAF156 was among the first of a new class of malaria drugs to enter mid-stage tests in more than 20 years, Novartis said last year. It expects to complete the phase 2b study by late 2019. Narasimhan added it's too early to say when it would reach the market.