Non-profit DNDi preps phase 3 trials for dengue antibody

The non-profit Drugs for Neglected Diseases initiative (DNDi) has joined forces with pharma group Serum Institute of India (SII) to advance a potential therapeutic for dengue into a late-stage clinical trial.

SII has licensed rights to the monoclonal antibody-based candidate – formerly known as VIS513 and originally developed by Otsuka subsidiary Visterra – to DNDi, paving the way for a 1,000-subject phase 3 trial that is due to start in the first quarter of next year.

The study will be conducted at sites in Malaysia, Thailand, and Brazil, all countries where dengue is endemic.

The viral infection is transmitted to humans through the bites of infected Aedes mosquitoes and causes flu-like symptoms – including high fever, severe headache, muscle and joint pain, and rash – but can occasionally progress to a life-threatening, severe form.

There is no current treatment for dengue other than hydration, clinical monitoring, and managing symptoms. And while a vaccine is available, it faces usage restrictions, such as only being an option for people who have previously been infected with the virus and a lack of protective efficacy against some serotypes.

VIS513, which targets an epitope on the virus and has been shown to neutralise all four serotypes of the virus (DENV-1 to 4), offers the hope of a post-infection treatment that could limit the severity of the infection and shorten its duration.

SII has developed and optimised the current formulation of the antibody and conducted preclinical studies and phase 1 and 2 clinical trials, with promising safety and efficacy results. It has already advanced the drug into a phase 3 trial in India.

"Serum Institute of India is committed to go all out in controlling dengue" commented Dr Rajeev Dhere, a senior scientific advisor at the company.

"We are working on both preventive and therapeutic applications to protect populations in dengue-endemic areas [and] will make all attempts to develop, produce, and distribute the vaccine and monoclonal antibodies all over the globe in an affordable manner," he added.

SII will supply refrigerated clinical supplies of the antibody for the DNDi-led trial, which is being supported with funding from the EU and France's development agency.

The WHO has estimated that the mosquito-borne disease infects around 390 million people each year and results in 20,000 deaths. It is endemic in more than 125 countries, including the US territories of Puerto Rico, the US Virgin Islands, and American Samoa, and is a leading cause of fever among travellers to Latin America, the Caribbean, and Southeast Asia.

However, fuelled by climate change and globalisation, dengue is expanding to many other parts of the world, including Europe.