GSK’s pediatric formulation of tafenoquine, its single-dose radical cure for P. vivax malaria, has scored its first approval. Australia cleared the drug for children ages 2-15 (for use in combination with chloroquine), the Medicines for Malaria Venture (MMV) announced Monday.
The decision was supported by Phase 2b trial data showing that tafenoquine was 95% efficacious at preventing disease recurrence in children ages 6 months to 15 years for four months post-treatment.
The…
The U.S. FDA has awarded Orphan Drug Designation to Zydus Cadila’s malaria therapeutic, the company announced last week.
The status gives the Ahmedabad-based drugmaker eligibility for “certain development incentives, including tax credits for qualified clinical testing, prescription drug user fee exemptions and seven-year marketing exclusivity upon FDA approval,” the press release said.
Zydus Cadila is developing the potential single-dose ZY19489 (MMV253) radical cure for P.…
The Lancet Infectious Diseases on Tuesday published first-in-human studies on a novel antimalarial compound that Merck KGaA is developing with the Medicines for Malaria Venture (MMV). The ascending-dose and volunteer infection studies support the development of M5717—a plasmodium eukaryotic translation elongation factor 2 inhibitor—as a component of a single-dose antimalarial combination therapy or for malaria prophylaxis, the article said.
However, an accompanying comment emphasized…
Novartis and Medicines for Malaria Venture (MMV) announced last week positive Phase 2b results for their novel non-artemisinin combination antimalarial. The study tested ganaplacide with a new formulation of lumefantrine optimized for once-daily dosing.
This combination has the potential not only to clear malaria infection, including artemisinin-resistant strains, but also to block the transmission of the malaria parasite, the press release said.
British researchers have identified a series of new drug compounds that could treat schistosomiasis, the London School of Hygiene & Tropical Medicine (LSHTM) announced on Wednesday.
LSHTM researchers and the nonprofit drug discovery company Salvensis screened more than 300,000 compounds—donated by the Medicines for Malaria Venture—to discover their ability to kill the three main species of parasitic worms.
In mouse models, the compounds were highly effective against both…
Japan’s Global Health Innovative Technology Fund announced $21 million in product development investments on Wednesday.
More than two-thirds of the awards will help advance six ongoing projects, while the rest fund four new investments: a leishmaniasis drug from Takeda and the Drugs for Neglected Diseases initiative; a malaria therapy from Eisai, the Medicines for Malaria Venture and the University of Dundee; a tuberculosis drug from Daiichi Sankyo RD Novare and the TB Alliance; and a…
Zydus Cadila announced last week that its ZY19489 (MMV253) malaria radical cure, co-developed with the Medicines for Malaria Venture, has succeeded in Phase 1.
The Ahmedabad-based company said healthy volunteers in Australia safely received escalating doses of 25 to 1,500 mg of the oral antimalarial compound. An additional P. falciparum malaria human challenge trial showed no serious or severe drug-related adverse events.
The results demonstrate that ZY19489 has the potential to…
Japan’s nonprofit Global Health Innovative Technology Fund (GHIT Fund) announced $2.2 million in drug development investments on Tuesday.
Three of the four awards support new projects for Chagas disease and malaria. The remaining award goes toward an ongoing drug discovery project between Takeda and Geneva-based Medicines for Malaria Venture.
GHIT Fund’s portfolio now includes 53 ongoing projects with $217 million invested so far, according to the press release.
An approved pediatric formulation of tafenoquine drew nearer last week after GSK and Medicines for Malaria Venture released new data showing that their single-dose radical cure for P. vivax malaria is safe and effective in children and adolescents ages 6 months to 15 years.
The Tafenoquine Exposure Assessment in Children (TEACH) study evaluated dosages of the oral 8-aminoquinoline drug based on weight, finding safety “consistent with previous clinical studies,” with 95% of subjects…
Geneva-based Medicines for Malaria Venture (MMV) yesterday launched Malaria Libre, an open-source antimalarial drug discovery program. Participating researchers will be able to access detailed information about compounds and upload their assay and other investigational results to a central MMV-moderated data repository.
MMV named India’s CSIR-Central Drug Research Institute, Jawaharlal Nehru University and TCG Lifesciences as early participants in the collaborative platform.