The first group of patients have been dosed in a human challenge study for malaria, being conducted by contract research organisation (CRO) Open Orphan.
The study is being conducted by Open Orphan subsidiary, hVIVO, and is taking place at the company’s facilities in London.
The first cohort of patients have now been inoculated with a GMP-manufactured malaria challenge agent as part of the company’s first controlled human malaria infection (CHMI) challenge study. The study will assess CHMI using existing standard of care antimalarial drugs against Plasmodium malaria.
Throughout the study volunteers will be inoculated with purified infectious P. falciparum (Pf) sporozoites harvested from the salivary glands of Anopheles stephensi mosquitoes, which are primarily found throughout Asia and parts of Africa.
The company believes that this type of malaria modelling with Plasmodium in antimalarial drug and vaccine trials has several potential advantages over traditional methods of P. falciparum infected mosquito challenges, including superior predictability, a cleaner safety profile and improved control over levels of infection.
Following the successful completion of the study, hVIVO will be able to sign malaria human challenge study contracts to assess the efficacy of novel antimalarial drugs and vaccines as well as correlates of immunity using a Plasmodium challenge agent.
Adrian Wildfire, director of Scientific & Business Strategy at hVIVO, said: “Malaria is a disease of significant unmet need around the world, with 241 million cases and 627,000 deaths caused in 2020. Its prevention and cure is a designated World Health Organization target. As such, we are pleased to have commenced this study to allow our clinical teams to better acquaint themselves with the recently established Controlled Human Malaria Infection model, ahead of using human challenge studies to test our clients’ malaria products. Data resulting from such studies translates well into the field and malaria human challenge studies have been pivotal to the development of many of the novel drugs now entering late phase trials.”
Cathal Friel, executive chairman of Open Orphan, said: “We are delighted to have inoculated the first cohort of volunteers for the Malaria study at our QMB facility in London. hVIVO is fully committed to growing the malaria model’s capabilities and capacity over the coming years to meet the challenge of accelerating the introduction of novel, safe and effective drugs and vaccines to the market.
“This study also ensures that Open Orphan is both strengthening and further diversifying the Company's world leading portfolio of viral challenge models. We look forward to updating the market in due course.”