Lumefantrine

FDA Places Clinical Hold on BioNTech's Novel Malaria Vaccine Trial

3 months ago

• The U.S. Food and Drug Administration has imposed a clinical hold on BioNTech's investigational malaria vaccine trial, temporarily halting the study's progression. • BioNTech's malaria vaccine candidate, which utilizes the company's mRNA technology platform, was being developed to address the global burden of malaria infection. • The clinical hold represents a significant setback in the development timeline for this potential breakthrough vaccine, though specific reasons for the FDA's decision have not been disclosed.

Novartis and MMV Advance Novel Malaria Drug Combination into Phase 3 Trials

4 months ago

• Novartis and Medicines for Malaria Venture (MMV) are progressing a new drug combination of ganaplacide and lumefantrine into Phase 3 trials to combat resistant malaria infections. • The novel non-artemisinin regimen aims to treat uncomplicated Plasmodium falciparum malaria with a once-daily solid dispersion formulation (SDF). • Phase 2 results showed the new combination was as effective as Coartem, potentially clearing artemisinin-resistant strains and blocking malaria parasite transmission. • A large Phase 3 trial will compare ganaplacide/lumefantrine with artemether/lumefantrine across multiple sites in sub-Saharan Africa.

Artemisinin Resistance Emerges in African Children with Severe Malaria

6 months ago

• A new study reveals that malaria parasites in African children are showing resistance to artemisinin, a key drug used to treat the disease. • Researchers found that some children experienced recurrent malaria episodes within a month of standard artemisinin-based combination therapy. • The study identified resistance mutations similar to those seen in Southeast Asia, marking their first detection in African children with severe malaria. • There is also a potential development of resistance to lumefantrine, a drug often used in combination with artemisinin, raising concerns about treatment efficacy.

First Participants Dosed in Trial of Long-Acting Malaria Preventative MMV371

7 months ago

• Medicines for Malaria Venture (MMV) and Quotient Sciences have initiated a Phase I trial of MMV371, a long-acting injectable (LAI) antimalarial drug. • The trial aims to assess the safety, tolerability, and pharmacokinetics of MMV371 in healthy participants, with potential for quarterly malaria prevention. • MMV371, derived from atovaquone, could provide up to three months of protection from malaria with a single intramuscular dose, pending successful trial outcomes. • Future plans include combining MMV371 with another drug like MMV055 to reduce the risk of resistance and conducting trials in malaria-endemic countries by 2026.

Novartis and MMV Develop Novel Malaria Treatment for Infants Under 5kg, Addressing Critical Treatment Gap

2 years ago

• Novartis and Medicines for Malaria Venture (MMV) have announced positive results from the CALINA study for a new formulation of Coartem® specifically designed for babies weighing less than 5kg with malaria. • The novel formulation uses a new ratio and dose of artemether-lumefantrine to account for metabolic differences in infants, addressing a significant treatment gap as no evidence-based malaria treatment currently exists for this vulnerable population. • If approved, Coartem <5kg Baby would be the first antimalarial specifically developed for the smallest infants, potentially saving countless lives in malaria-endemic regions where current treatments risk overdose and toxicity in this age group.

FDA Places Clinical Hold on BioNTech's Novel Malaria Vaccine Trial

Novartis and MMV Advance Novel Malaria Drug Combination into Phase 3 Trials

Artemisinin Resistance Emerges in African Children with Severe Malaria

First Participants Dosed in Trial of Long-Acting Malaria Preventative MMV371

Novartis and MMV Develop Novel Malaria Treatment for Infants Under 5kg, Addressing Critical Treatment Gap

Drug Development Updates