Open Orphan subsidiary develops human study for malaria

Dublin-listed pharmaceutical services company Open Orphan has announced that its subsidiary, Hvivo, has developed a controlled human malaria infection challenge model.

In virus challenge studies, healthy volunteers are administered a pathogenic or virulent strain of virus. These challenge agents are then used in controlled human infection studies, an area that Hvivo has focused on since 2001.

The company said the move would both strengthen and further diversify its portfolio of viral challenge study models.

The challenge model will assist in the advancement of antimalarial drug and vaccine candidates from November. Results from the modelling of drug and vaccine efficacy had previously shown good translation into the field, the company said.

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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 standalone 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.

As of June, 1,204 volunteers have taken part with no unresolved serious adverse events or deaths. Reported symptoms are mostly mild to moderate and include headache, fever, nausea and fatigue.

Open Orphan, a European-focused, rare and orphan drug consulting services platform, is the result of executive chairman Cathal Friel reversing his pharma services business of the same name into Dublin-listed drug clinical trials manager Venn Life Sciences.

"Malaria is a disease of huge unmet need around the world, with 229 million cases and 409,000 deaths caused in 2019," said Mr Friel. "Its prevention and cure is a designated World Health Organisation 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 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.”