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Novartis And Medicines For Malaria Venture Annoncent Leur Décision De Passer À La Phase 3 De L’étude Sur La Nouvelle Combinaison Ganaplacide/Luméfantrine-Sdf Chez Les Adults Et Les Enfants Ateints Du Paludisme – 237Online.com


Novartis and Medicines for Malaria Venture (MMV) announce decision to proceed to Phase 3 of study on novel artemisinin-free combination for treatment of uncomplicated malaria

· This new combination also includes an optimized formulation of lumefantrin, which allows once-daily dosing instead of the usual twice-daily dosing.

· Alors que le monde est confonn à une resistance émergente aux treatment actels du paludisme, de nouveaus medicaments sont necessaires pour pursuivre la lutte en view de l’elimination de la maladie

Basel, Switzerland, 24 November 2022, -/African Media Agency (AMA)/- Alors que la menace de résistance aux traitements actels contre le paludisme grows1,2.

Ganapracid is a new drug with a new mechanism of action associated with a new formulation of lumefantrin optimized for a unique daily dose. Cette’s combination is a potential non-separable deliminator l’palustre of infection, consisting of y compris les souches résistantes à l’artémisinine, mais aussi de bloqueur la transmission du parasite du paludisme. The drug is being developed with scientific and financial support from MMV and her six partners.

As previously published, an open, randomized, controlled phase 2 trial was conducted in 524 adults and children with uncomplicated acute malaria due to Plasmodium falciparum infection. L’association ganaplacide/luméfantrine-SDF a atteint l’objectif primaire chez les adultes et les enfants. , was similar to the rate observed in patients treated for 3 days.

Compare l’efficacy du ganaplacide/luméfantrine-SDF à celle de l’artéméther-luméfantrine, le traitement de référence actuel before the third stage Grand Ambergue, before its debut in 2023. The study was conducted in collaboration with the consortium WANECAM 2 and includes partner clinical sites in Burkina Faso, Mali, Gabon, Niger, and other sites in sub-Saharan Africa. Les deux études de phase 2 et 3 is funded by the European Union-supported European and Developing Countries Clinical Trials Partnership (EDCTP).

« The emergence of resistance to artemisinin calls for urgent action to develop new antimalarial drugs. We need dosing regimens that are easy to follow,” said Dr. Sujata Vaidyanathan, head of Novartis’ Global Health Development Unit. « The sooner we dispose of new drugs, and the sooner the world adopts them, the greater our chances of defeating resistance.»

Dr. Timothy Wells, MMV Chief Scientific Officer, said: « If Phase 3 trials are definitive, this new combination will increase the number of options available to the country and help save the lives of children exposed to this devastating disease.»

In August 2022, the U.S. Food and Drug Administration (FDA) granted expedited processing (Fast Track designation) to the association of ganapracid and lumefantrine-SDF for the treatment of uncomplicated acute malaria and an orphan drug designation. Approved for registration as a drug.

Le paludism à Plasmodium falciparum Est Principal Trait Per De Combinazon Therapeutic A Base Dartemisinin (ACT) Delivers Artemether Lumefantrin. Les ACT sont toujours très efficaces et bien tolerés. Novartis introduced the first fixed dose ACT combination in 1993.3 et a depuis fourni plus d’un milliard de treatment antipaludiques, en grande party sans aucun Profit. In collaboration with MMV, Novartis Miss au Point One formulation is a dispersible au goût masqué de Coartem pour les enfants, a été utilisateur pour traiter plus de 450 million d’enfants, principle en Afrique. Cependant, l’augmentation de la fréquence à la laquelle des parasites réagientes plus lentement à l’artémisinin sont observés dans certaines régions d’Afrique de l’Est (Rwanda, Uganda, Corne de Lafrique) montre qu’il est Emergency de developer une nouvelle classe d’antipaludiques sans artémisinin afin d’evitar un retour aux niveaux élevés de mortité Infantile Observés dans les années 1990.

dispersed fatherr African Media Agency (AMA) of Novartis.

Supplementary matter

According to the latest global report on malaria, published in December 2021, it is estimated that 241 million malaria cases and 627,000 deaths will occur worldwide in 2020.1 This represents about 14 million additional cases and 69,000 additional deaths in 2020 compared to 2019. Approximately two stages (47,000) of these additional deaths were related to disruptions in the supply of interventions for malaria prevention, diagnosis and treatment caused by the COVID-19 pandemic.

Ganapracid is the result of a collaborative research program supported by the Wellcome Trust, Medicines for Malaria Venture (MMV), and the Singapore Economic Development Board, with Institut Novartis pour les maladies tropicales, Institut de génomique de la Fondation de recherche Novartis et l ‘Institut suisse de santé publique et tropicale. This research program aims to discover the next generation of antimalarial drugs.

In 2022, at the Kigali Summit on Malaria and Neglected Tropical Diseases, Novartis reaffirms its commitment to malaria R&D and will invest $250 million to accelerate R&D on malaria and tropical diseases announced. Cela comprende des antipaludéens de nouvelle génération et une nouvelle formula d’artémisinine-luméfantrine pour les bébés de moins de 5 kg atteints de paludisme.

WANECAM 2 (West African Network for Clinical Trials of Antimalarial Drugs, 2nd Edition) was published in Africa (Burkina Faso, Gabon, Mali and Niger) and Europe (Angleterre, France, Allemagne, Pays-Bas et Suede). Reso is working with Novartis and MMV. The consortium, funded by EDCTP, aims to accelerate the development of the association Ganaplacid/Lumefantrin Pour Le Traitment du Pardisme Non Comprique En Menant de Esse Clinique Dans Quatre Pays Duffric Occidental et Central. Additionally, the project includes activities such as the formation and development of infrastructure to support the development of antimalarial drugs.See the site for more information https://www.wanecam.org.

non-liability clause

The current document is part of a forecast involving known and unknown risks, uncertainties and other factors that may cause actual results to differ materially from any results, performance or achievements expressed or implied in the statement. There is a possibility. The specific risks associated with these statements are summarized in the English version of this communiqué.

About Novartis

Novartis is reinventing medicines to improve and extend people’s lives. Thanks to our technological leadership in research and development and new approaches to access, we provide medicines of superior quality that reduce the burden of some of society’s most serious diseases. In the quest for new medicines, we systematically rank the world’s leading companies and invest in research and development. Nearly 108,000 people from more than 140 nationalities work together to provide Novartis products to approximately 800 million people worldwide.See the site for more information https://www.novartis.com.

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About MMV

Medicines for Malaria Venture (MMV) is a premier plan product development partnership (PDP) in the field of antimalarial drug research and development. Its mission is to reduce the burden of malaria in malaria-endemic countries and to facilitate the discovery, development and supply of new effective and affordable antimalarial drugs.

Since its founding in 1999, MMV and its six partners have managed the largest portfolio of antimalarial drug access and R&D projects ever established, launching 12 new drugs and expanding to two others. You have taken over the management of access. A $3 million pre-de-vie-on-te-sauve, thanks to a drug co-developed by MMV. MMV’s success depends on a strong network of around 150 active partners worldwide from the pharmaceutical industry, academia and endemic countries.

MMV’s vision is a far-reaching world where innovative medicines will enable the treatment and protection of malaria-exposed vulnerable populations and underserved services, helping to eradicate this horrific disease.

See website for details www.mmv.org

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References

1Organization mondiale de la santé, Rapport mondial sur le paludisme 2020. Disponible sur : https://www.who.int/teams/global-malaria-programme/reports/world-malaria-report-2020

2 B. Balikagala, N. Fukuda, M. Ikeda, M. Ikeda, OT Katuro, SI Tachibana, M. Yamauchi, others., (2021) Evidence for artemisinin-resistant malaria in Africa N. Engl. J. Med., 385 (13) pp. 1163-1171. available: https://www.nejm.org/doi/full/10.1056/NEJ Moa2101746

3 Premzi ZG. Courtem: Journey to the clinic. Malar J. 12 Oct 2009;8 Suppl 1(Suppl 1):S3

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