hVIVO, a subsidiary of the specialist contract research organisation, Open Orphan (ORPH ), said it has now inoculated the first cohort of volunteers with a GMP-manufactured malaria challenge agent as part of its first controlled human malaria infection (CHMI) challenge study.
The CHMI challenge study, which is expected to be completed in 1Q22, will assess CHMI using existing standard of care antimalarial drugs against Plasmodium malaria in patients.
For the challenge study, which is taking place at hVIVO’s facilities which are based in London, hVIVO has leveraged its extensive experience in clinical trial recruitment, via its clinical trial recruitment arm FluCamp, to identify and screen volunteers to rapidly enrol the study cohort.
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, Open Orphan noted.
hVIVO’s Direct Venous Inoculation (“DVI”) clinical trial protocol was reviewed by all necessary UK regulatory bodies and fully approved prior to the start of this controlled challenge study.
The company explained that expert diagnostic services from the London School of Hygiene and Tropical Medicine have been contracted to monitor the welfare of subjects and provide essential correlates relating to drug and vaccine efficacy during the CHMI challenge study.
Additionally, comprehensive training programmes have been completed by staff and senior professional oversight put in place for the review of scientific and safety data, it stated.
This malaria model consists of inoculating volunteers with purified, infectious P. falciparum (Pf) sporozoites, harvested from the salivary glands of Anopheles stephensi mosquitoes.
The company explained to investors that this type of malaria challenge model has already been safely used in multiple clinical trials across the United States, Europe and Africa.
It said c malaria modelling with Plasmodium in antimalarial drug and vaccine trials has several potential advantages over traditional methods of P. falciparum infected mosquito challenge, including “superior predictability, a cleaner safety profile and improved control over infection levels.”
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 WHO 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: “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.”
Friel added that the challenge study also ensures that Open Orphan is both “strengthening and further diversifying the Company’s world leading portfolio of viral challenge models.”
Last month, hVIVO announced that it had signed a £5m influenza human challenge study contract to develop an antiviral drug for protection against respiratory viral infections.
hVIVO has two decades of experience and expertise in safely conducting challenge studies across a range of respiratory viruses, including RSV, various strains of Influenza, human Rhinovirus HRV, malaria, and asthma. In 2020, this expanded to include SARS-CoV-2.
The influenza human challenge study is expected to commence in 2H22 and will test and assess the efficacy of a single dosing regimen of the client’s antiviral drug in healthy adult volunteers using hVIVO’s Influenza human challenge study model, the company explained.
Open Orphan told investors that it expects the majority of revenues from the study to be recognised in 2022. The study will be conducted at hVIVO’s London-based facilities.
Healthy volunteer human challenge studies of wild-type influenza play a major role in the development of vaccines and therapeutics against influenza, the company explained.
Respiratory tract infections are infections of parts of the body involved in breathing, such as the sinuses, throat, airways or lungs and are often caused by viruses such as influenza.
‘Seasonal influenza causes significant morbidity and mortality each year and a pandemic influenza continues to pose a worldwide threat. Influenza is a serious global health problem. Influenza is a serious global health threat with an estimated 1 billion cases per year, 3-5 million severe cases and 290,000 – 650,000 deaths per year,’ Open Orphan told investors.
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