SGS is conducting its first malaria human challenge trial
The contract research organization (CRO) is conducting the trial on behalf of the Medicines for Malaria Venture (MMV), a not-for-profit public-private partnership.
The experimental compound – a potential long-acting injectable chemoprotective drug – will be tested for its ability to kill malaria parasites in the liver before they reach the bloodstream.
The volunteer infection study (VIS) is being conducted at SGS’ 20-bed unit at the Stuivenberg Hospital in Antwerp, Belgium. The unit provides level 2 containment and has full isolation capabilities.
According to the World Health Organization (WHO), 2017 saw an estimated 219m cases of malaria in 90 countries, with the death toll reaching approximately 435,000.
An estimated $3.1bn was invested in controlling and eliminating malaria in 2017. Contributions from governments of endemic countries was approximately 28% of the total funding at $ 900m.
“Being able to monitor for the presence or absence of blood parasites with a benchmark level of quality and timeliness is integral to subject safety in controlled human malaria infection trials,” said Adrian Wildfire, project director, infectious diseases and human challenge unit at SGS.
Twenty-four healthy volunteers will be intravenously inoculated with living, infectious, cryopreserved malaria parasites and will be monitored during the containment period and examined before discharge at day 35.
Wildfire said safety is always the company’s first priority, with quality a close second. “Having a rapid turn-around for PCR results and a trained clinical team on hand to both interpret and translate such results ensures the volunteers experience minimal symptoms and a high standard of care within a hospital environment,” he told us.
If the study meets its endpoints, the next step is to finalize the design and manufacture of a depot formulation for slow-release/long action, explained Wildfire. This would be followed by a titration study in September to determine dosage.
“As Belgium is becoming the ‘go-to’ country for Europe’s challenge trial needs, SGS is well placed to work with clients, partners, collaborators, and academic research bodies to provide solid, prognostic data prior to roll-out of programs into the field,” added Wildfire.
SGS also is in discussions with other MMV associates to progress promising drug candidates “as part of a global endeavor to tackle drug-resistant malaria,” he said.
“It is an exciting time for all parties and should help energize the market into looking further into reducing the global burden of malaria; especially in the under 5 year old, pediatric population, where up to 300,000 die each year from complications associated with infection.”
Wildfire also noted that without the foresight of the Belgian Regulatory Health Authorities (FAGG), none of this would have been possible. “It is very heartening to have the support of Belgium academics and leading Malaria physicians in helping design and perform certain aspects of such studies,” he said.
As part of its work, MMV in 2016 initiated an open-source drug discovery project to examine candidates previously not thoroughly investigated.
The organization sent out 400 compounds via a “Malaria Box,” which were distributed free of charge to researchers globally. The project gave rise to more than a dozen drug development projects.
