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Last week, Novartis and Venture Medicines for Malaria (MMV) announced that they are moving forward with a Phase 3 trial of a novel fixed-dose combination drug – ganaplacide/luefantrine – for patients with uncomplicated malaria. Plasmodium falciparum Parasite. The clinical trial will test the effectiveness of ganaplacid/lumefantrine versus the current standard treatment, artemether/lumefantrine.

In August of this year, the Food and Drug Administration (FDA) granted Fast Track and Orphan Drug designation to ganaplacide/lumfantrine for the treatment of acute and uncomplicated malaria.

If the Phase 3 trial is successful, the drug could be an alternative to artemisinin-based treatments, which are being challenged by artemisinin-resistant strains of malaria. Indeed, as the world develops resistance to current malaria treatments, new drugs are critical.

Malaria is a disease that kills about 600,000 people a year; Mostly African children. In the year The latest World Malaria Report, released in December 2021, shows that in 2020, there were an estimated 241 million malaria cases and 627,000 deaths worldwide.

Plasmodium falciparum Malaria is primarily treated with artemisinin-based combination therapies (ACTs), such as artimet-lumefantrine. ACTs are highly effective and well tolerated. Novartis introduced the first fixed-dose combination ACT in 1999 and has since administered more than one billion courses of antimalarial therapy, mostly at no profit.

In the year In the early 2000s, with the non-profit public-private partnership MMV, Novartis created a dispersant Preparation of artemisinin / lufafantrine for children; A cherry-flavored product called Coartem is currently used to treat more than 450 million children, mainly in Africa.

However, the frequency with which resistant strains are being observed shows that there is an urgent need to develop new non-artemisinin antimalarials to prevent a return to the high levels of childhood mortality last seen in the 1990s.

The investigational product ganaplacide/luefantrine has demonstrated the ability to clear malaria infections, including artemisinin-resistant strains.

Ganaplacid is a next-generation antimalarial agent with a novel mechanism of action. It was developed as part of a collaborative research program by the Novartis Institute of Tropical Diseases, the Genomics Institute of the Novartis Research Foundation and the Swiss Institute of Tropical and Public Health. The Wellcome Trust, MMV and the Singapore Economic Development Board contributed funding to the research effort.

The solid suspension formulation of lumefantrine in the ganaplacid/lumefantrine combination allows for once-daily administration.

In initial tests, the product showed the ability to block the spread of malaria parasites. A phase 2 open-label, randomized controlled study was conducted in 524 adults and children with severe uncomplicated malaria. Plasmodium falciparum Infection. The ganaplacid/lumefantrine combination met the primary objective in both adults and children.

Malaria has received more media attention and research and development funding than any of the so-called “big three infectious diseases”—HIV/AIDS, tuberculosis, and malaria—as a neglected tropical disease.

However, funding cuts in recent years – in part due to a shift in resources to combating Covid-19 – mean that the number of malaria-targeted drugs and vaccines has remained the same at 10 since 2011. 2011 years ago.

However, some significant improvements have been made. In the year In 2018, the FDA approved a new drug that targets a specific type of malaria that causes about 8.5 million infections a year. About 15-20% of malaria cases worldwide. A new drug called Crentafel (tafenoquine) prevents malaria from relapsing Plasmodium vivaxAnother parasite.

Also, last year, the World Health Organization endorsed the first malaria vaccine for use in children in high-risk areas. The vaccine – called Mosquirix – has moderate effectiveness, as it reduces the number of severe malaria cases by approximately 30%.

This year, Novartis announced its commitment to malaria R&D at the Malaria and Neglected Tropical Diseases Summit in Kigali, investing $250 million over the next five years in both malaria and neglected tropical diseases.

And now, as ganaplacide/luefantrine enters the next phase of development, there is hope for further progress in the fight against malaria. The Phase 3 trial of ganaplacide/luefantrine is being conducted in collaboration with the West African Network for Clinical Trials of Antimalarials consortium and will include partner clinical sites in Burkina Faso, Mali, Gabon and Niger, as well as other sites in sub-Saharan Africa. Africa.

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