Clinical trial underway for new bilharzia drug

A clinical trial to determine the efficacy of a new drug to treat snail fever is currently underway in the country.

The trial, being overseen by the Kenya Medical Research Institute (Kemri) is targeting children under the age of six. The trial is being carried out in Kenya and Ivory Coast where 311 children are to be dosed. Kenya will dose 160 children in Homa Bay County.

 According to the pharmaceutical company behind the tablet, Merck Group, the people were not getting the right treatment with the current medication.

Currently, children get treated with the same tablet, albeit the Head of Corporate Affairs and Senior Vice President of Merck Group Dr Petra Wicklandt said that the tablet is unsuitable for them.

“The current tablet we donate is very big and bitter and not appropriate for this population as small children have difficulties swallowing,” she said. “The new tablet can be dissolved in water and in the tongue, is smaller, and less bitter.”

Wicklandt said once the tablet gets approval, the company can issue a license to a local manufacturer.

“We then hope the government will buy the drug from them,” she said.

The clinical trial will end in March 2020. Thereafter a clinical report, as well as regulatory documentation, will be combined and submitted to the European Medicine Agency. The agency will then take a year to review the documents.

At the same time, Wicklandt said a process for World Health Organisation(WHO) pre-qualification will be initiated so that the drug can be added to the essential medicine list.

“We hope the drug will be available in 2022,” she said.

Snail fever, also known as bilharzia or schistosomiasis, according to Principal Researcher at Kemri Dr Maurice Odiere is prevalent in 158 sub-counties. Some of the affected areas are lake basin areas like Migori, Kisumu and Homa Bay where the strain that exists is the one that causes intestinal bilharzia.

Other areas are Kirinyaga County around the rice farming areas where residents are at risk of both intestinal and urogenital bilharzia.

Odiere estimated that almost a million people are at risk of bilharzia since the endemic areas cover more than 50 per cent of the country.

“We do not have very good diagnostic tools and there has not been much work done in surveying this population, so we would likely be underestimating those numbers,” he said.

Odiere noted that the problem with bilharzia is that it mimics other diseases with symptoms like diarrhoea and abdominal pains.

“There are however those that are suggestive for bilharzia like blood in stool, urine and enlargement of spleen and liver,” he said.

Untreated bilharzia can end up causing damage to the liver, spleen or bladder. Dr Odiere said some of these effects can only show up after decades.