Last week, Novartis and the Medicines for Malaria Venture (MMV) announced that they were moving forward with a Phase 3 trial for a new fixed-dose combination drug – ganaplacid/lumefantrine – for patients with uncontrolled malaria. complicated caused by Plasmodium falciparum parasite. The clinical trial will test the effectiveness of ganaplacide/lumefantrine compared to the current standard treatment, artemether/lumefantrine.
In August of this year, the Food and Drug Administration (FDA) granted expedited and orphan drug designation to ganaplacid/lumefantrine for the treatment of acute, uncomplicated malaria.
If the phase 3 trial proves successful, the drug could be an alternative to artemisinin-based treatments, which are increasingly being challenged by artemisinin-resistant strains of malaria. Indeed, as the world faces emerging resistance to current malaria treatments, new drugs are essential.
Malaria is a preventable disease that kills around 600,000 people a year; mainly African children. According to the latest World Malaria Report, released in December 2021, there were approximately 241 million cases of malaria and 627,000 deaths worldwide in 2020.
Plasmodium falciparum malaria is mainly treated with artemisinin-based combination therapy (ACT) such as artemether-lumefantrine. ACTs are very effective and well tolerated. Novartis introduced the first fixed-dose combination ACT in 1999 and has since delivered more than a billion antimalarial treatments, largely without profit.
In the early 2000s, in conjunction with the non-profit public-private partnership MMV, Novartis developed a dispersible formulation of artemether/lumefantrine for children; a cherry-flavored product called Coartem, which is now used to treat more than 450 million children, mostly in Africa.
However, the increased frequency of observation of resistant parasites indicates an urgent need to develop a new class of non-artemisinin antimalarials to avoid a return to the high levels of infant mortality last seen in the 1990s.
The investigational product ganaplacid/lumefantrine has shown the potential to eliminate malarial infections, including those caused by artemisinin-resistant strains.
Ganaplacide is a new generation antimalarial agent with a new mechanism of action. It was developed through a collaborative research program led by the Novartis Institute for Tropical Diseases, the Genomics Institute of the Novartis Research Foundation and the Swiss Tropical and Public Health Institute. The Wellcome Trust, MMV and the Singapore Economic Development Board helped fund the research effort.
The solid dispersion formulation of lumefantrine contained in the ganaplacid compound/lumefantrine combination allows for once-daily administration.
In preliminary trials, the product demonstrated its ability to block the transmission of the malaria parasite. A randomized, open-label phase 2 controlled study was conducted in 524 adults and children with uncomplicated acute malaria due to Plasmodium falciparum infection. The ganaplacid/lumefantrine combination achieved the primary objective in both adults and children.
Malaria is one of the so-called “three major infectious diseases” – HIV/AIDS, tuberculosis and malaria – which have generally received more media attention and research and development funding than the neglected tropical diseases.
However, funding cuts in recent years – partly due to a diversion of resources towards the fight against Covid-19 – mean that the number of drugs and vaccines being treated that target malaria is roughly the same since 2011 as the 10 years before 2011.
Nevertheless, notable progress has been made. In 2018, the FDA approved a new drug for a particular type of malaria that accounts for approximately 8.5 million infections per year; approximately 15-20% of all malaria cases worldwide. The new drug, Krintafel (tafenoquine), prevents relapse of malaria caused by Plasmodium vivaxanother parasite.
Additionally, last year the World Health Organization approved the first malaria vaccine for use in children in at-risk areas. The vaccine – called Mosquirix – has modest efficacy, reducing the number of cases of severe malaria by around 30%.
This year, Novartis reaffirmed its commitment to malaria R&D at the Kigali Summit on Malaria and Neglected Tropical Diseases, announcing a $250 million investment to advance malaria and neglected tropical disease R&D. neglected tropics over the next five years.
And now, as ganaplacide/lumefantrine enters the next stage of development, there is hope for further improvements in the fight against malaria. The phase 3 trial involving ganaplacide/lumefantrine will be conducted in collaboration with the West African Network for Clinical Trials of Antimalarial Drugs 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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