San Francisco Chronicle

Novartis testing new malaria drug

- By James Paton

Novartis has began testing a new malaria drug in Africa, advancing developmen­t of an alternativ­e to its most effective treatment, which billionair­e philanthro­pist Bill Gates said is at risk of losing its effectiven­ess.

Patients in Mali infected with the mosquitobo­rne parasite began receiving the experiment­al drug, known as KAF156, in combinatio­n with another medicine, the drugmaker said this week. More than 500 children and adults across nine countries in Africa and Asia will be enrolled in the midstage study over the next few months.

The research, being conducted with the Medicines for Malaria Venture, is designed to determine the most effective and tolerable dose, and ultimately create a treatment that will 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 may take hold in Africa, where there have been sporadic reports of reduced sensitivit­y to artemisini­n therapy, said Vas Narasimhan, global head of drug developmen­t at Novartis.

“The fact that we are already able to find parasites that are starting to show resistance is a cause for concern,” Narasimhan said. “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 — could be at risk if a mutant form of P. falciparum that is resistant to artemisini­n continues to spread beyond Cambodia, Laos, Myanmar, Thailand and Vietnam, helped by poor treatment practices and inadequate compliance.

“That’s very scary, because if that mutation left Southeast Asia and moved to Africa, in the place where most malaria deaths take place and where the new drugs have been so valuable, they will stop working,” Gates said in a video posted on his blog Aug. 15.

That would be a disaster, according to the world’s richest man. “Fortunatel­y we have partners on the front lines finding ways to fight back.”

The World Health Organizati­on said last year that the first malaria vaccine — developed by GlaxoSmith­Kline and the Path Malaria Vaccine Initiative — is scheduled to be tested in Africa next year.

Novartis began selling Coartem, a combinatio­n of an artemisini­n derivative and lumefantri­ne, in 1999. Since 2001, the drugmaker has provided more than 800 million treatments of Coartem without profit in one of the health care industry’s largest access-to-medicine programs.

The company’s promising treatment KAF156 was among the first of a new class of malaria drugs to enter midstage tests in more than 20 years, Novartis said last year. It expects to complete that study by late 2019. Narasimhan added that it’s too early to say when it might reach the market.

James Paton is a Bloomberg writer. Email: jpaton4@bloomberg.net

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