Novartis starts testing new malaria drug as resistant strain spreads

Author: James Paton

Source: Business Day

Novartis began testing a new anti-malaria pill in Africa, advancing development of an alternative to its most effective treatment, which billionaire philanthropist Bill Gates has said risks losing potency.

Patients in Mali infected with the mosquito-borne parasite began receiving the experimental drug, known as KAF156, in combination with another medicine, the drug maker said on Monday. 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 an unmet 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.

“The fact that we are already able to find parasites that are starting to show resistance is a cause for concern,” Narasimhan said 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 Organisation (WHO).

‘Very scary’

A steady decline over the past decade in the global malaria death toll — which was 429,000 in 2015 — could reverse 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.

“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 on August 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.”

WHO said last year it was rolling out the first malaria vaccine — developed by GlaxoSmithKline and the PATH Malaria Vaccine Initiative — in pilot projects in Africa, with vaccinations to begin in 2018.

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

The company’s promising treatment 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 said it was too early to say when it would reach the market.