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In a significant step forward in the fight against the deadly Nipah virus, a novel monoclonal antibody (mAb) developed by Mapp Biopharmaceutical is set to undergo human clinical trials in India and Bangladesh in 2025. These two countries experience frequent outbreaks of the virus, which is known for its high mortality rate and rapid transmission.
The Nipah virus, part of the Paramyxovirus family, can kill up to 75 percent of those it infects, making it one of the most lethal zoonotic diseases. Currently, there are no approved treatments or vaccines for the virus. This upcoming trial aims to change that by assessing the safety and tolerability of the Nipah monoclonal antibody MBP1F5.
MBP1F5, a protein designed to mimic natural antibodies, works by binding to the virus and preventing infection. The clinical trials will be funded by a $43.5 million grant from the Coalition for Epidemic Preparedness Innovations (CEPI), with the trials set to commence pending regulatory approval. The trials will involve healthy adults at multiple clinical trial sites across India and Bangladesh.
In addition to the clinical trials, the funding will support preclinical studies aimed at expanding the use of MBP1F5 from pre-exposure prophylaxis (preventing infection before exposure) to post-exposure prophylaxis, which is crucial for treating individuals shortly after they have been infected with the virus.
“A monoclonal antibody capable of offering immediate protection for caregivers and others at risk of infection would be an important addition to our armamentarium against the Nipah virus,” said Richard Hatchett, CEO of CEPI.
The MBP1F5 antibody works by binding to the Nipah virus F protein, a mechanism that prevents the virus from entering host cells and causing infection. This method offers protection against both known strains of the Nipah virus (Bangladesh and Malaysia) and its closely related viral cousin, the Hendra virus. According to company researchers, this protection can last for at least six months, which is sufficient time for vaccine-induced immunity to develop.
Brent Yamamoto, a representative from Mapp Biopharmaceutical, highlighted the potential of MBP1F5, stating, “In preclinical models, MBP1F5 has shown incredible potential for preventing and treating Nipah.”
As the world continues to grapple with the threats posed by emerging infectious diseases, the development and trial of MBP1F5 represent a beacon of hope for regions regularly afflicted by the Nipah virus. If successful, this antibody could be a game-changer in the global effort to combat one of the most dangerous viruses known to humanity.
