The first new malaria drug to emerge for 20 years is beginning clinical trials in nine countries across Africa and Asia. KAF156 could be "a game changer", its developers say, at a time when the malaria parasite is evolving resistance to existing treatments.
Novartis, the Swiss drug company, has developed KAF156 in collaboration with Medicines for Malaria Venture (MMV), a public-private partnership, and charities including the Wellcome Trust and Gates Foundation.
Research suggests that the new medicine quickly clears malaria infection, including resistant strains, and blocks transmission of the parasite, said Vas Narashimhan, Novartis head of drug development.
About 500 adults and children suffering from malaria will take part in the trial over the next couple of years in two Asian and seven African countries.
They will receive various doses of KAF156 combined with an old antimalarial called lumefantrine. Results will be compared with a combination therapy based on artemisinins, which are the best antimalarials available today but are becoming less effective as resistance increases.
"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 David Reddy, MMV chief executive.
"With the trial of KAF156-lumefantrine now under way, the MMV - Novartis partnership is drawing closer to the exciting prospect of such a new medicine that would be a powerful tool to fight the disease."
A fight on three fronts
According to the World Health Organization, the annual total of malaria deaths has fallen by half since 2000.
But the global toll is still about 440,000 a year and experts fear that drug resistance could drive a resurgence of the disease.
Most victims are very young Africans. In 2015, the disease killed an estimated 292,000 children in Africa before their fifth birthday.
Eliminating malaria will require success on three fronts, Dr Reddy said: better drugs such as KAF156 to fight the parasite; more effective vaccines to prevent infection; and "vector control" to stop mosquitoes transmitting the disease.
The KAF156 trial will begin with adults and, if no unexpected safety problems emerge, move on to children next year. "We hope to get results by the end of 2019 and then go into a [larger trial] with 750 to 1,000 patients," said Dr Narashimhan.
KAF156 emerged from the screening of thousands of chemicals for antimalarial activity at the Novartis Institute for Tropical Diseases in Singapore. Another drug candidate that emerged from the same source, called KAE609, is also in development though running slightly behind KAF156 in its clinical trial schedule.
The commitment of Basel-based Novartis to antimalarials is a combination of business and philanthropy, said Dr Reddy. "If a company is looking only at commercial return, they are not going to be part of this," he added. "In the long term, Novartis is approaching malaria on a no profit, no loss basis.
Copyright The Financial Times Limited 2017