Open Orphan plc (LON:ORPH), a rapidly growing specialist clinical research organisation (CRO) and world leader in testing vaccines and antivirals using human challenge clinical trials, announces that its subsidiary, hVIVO, has developed a Controlled Human Malaria Infection (“CHMI”) challenge model, both strengthening and further diversifying the Company’s world leading portfolio of viral challenge study models. The Malaria challenge model will assist in the advancement of antimalarial drug and vaccine candidates from November 2021. Results from CHMI modelling of drug and vaccine efficacy have previously shown good translation into the field.
Malaria is a serious and life-threatening disease prevalent across much of tropical and sub-tropical Asia, South America and Sub-Saharan Africa. Due to increasing resistance to current antimalarial regimens, new drugs are required as both stand-alone and partner therapies to address a growing unmet medical need. In addition, novel combinations of existing drugs may be required to fill the gap until pipeline candidates can be safely progressed to market. New drugs and combination therapies are required to not only reduce mortality and morbidity in susceptible, primarily paediatric populations, but also to help the move towards a greater goal of malaria elimination.
hVIVO has secured access to a unique, GMP-manufactured P. falciparum sporozoite challenge agent (“PfSPZ Challenge”) for use in its malaria challenge studies. PfSPZ Challenge has been used in multiple clinical trials in the United Kingdom, United States, Europe, Indonesia and Africa. As of June 2021, 1,204 volunteers have received 2,011 doses of PfSPZ Challenge (NF54) with no unresolved serious adverse event, sequelae, or deaths to date. Controlled Human Malaria Infection by Direct Venous Inoculation has largely replaced the traditional method of CHMI (mosquito bite), owing to its superior predictability and safety profile. Reported symptoms are mostly mild to moderate and include headache, fever, nausea and fatigue.
Cathal Friel, Executive Chairman of Open Orphan, said: “Malaria is a disease of huge unmet need around the world, with 229 million cases and 409,000 deaths caused in 2019. Its prevention and cure is a designated World Health Organization target. We are pleased to have formally announced today the latest addition to our portfolio of human challenge models namely the Malaria Human Challenge Study Model. The safety profile of PfSPZ is impressive, and we are optimistic that it will enable us to assist in the advancement of antimalarial drug and vaccine candidates from November. This also adds a new challenge model to our already world leading portfolio of viral challenge study models and continues to build on our global infectious disease expertise.”
