MMV367 / GSK, Medicines for Malaria Venture - LARVOL DELTA

First-in-human safety, tolerability, pharmacokinetics and pilot food-effect study of the candidate antimalarial compound MMV367. (PubMed, Br J Clin Pharmacol) - "MMV367 demonstrated acceptable safety, tolerability and pharmacokinetic profiles supporting further development as an antimalarial drug."

Clinical • Journal • P1 data • PK/PD data • Infectious Disease • Malaria

The non-artemisinin antimalarial drugs under development: a review. (PubMed, Clin Microbiol Infect) - "Although attrition remains a possibility, several promising candidate drugs with novel modes of action are advancing through clinical development. Many are expected to become available for treating uncomplicated and severe malaria within the next decade. These new antimalarials could significantly enhance malaria treatment, reduce resistance, and support global health effort toward malaria control, elimination, and, potentially, eradication."

Journal • Review • Infectious Disease • Malaria

First-in-human safety, tolerability, pharmacokinetics and pilot food-effect study of the candidate antimalarial compound MMV367. (PubMed, Br J Clin Pharmacol) - "MMV367 demonstrated acceptable safety, tolerability and pharmacokinetic profiles supporting further development as an antimalarial drug."

Journal • P1 data • PK/PD data • Infectious Disease • Malaria

A phase 1b study to characterize the safety and pharmacokinetic/pharmacodynamic relationship of MMV367 (GSK701) in adult participants experimentally infected with blood- stage Plasmodium falciparum (ASTMH 2024) - P1 | "All 6 participants received rescue treatment with artemether-lumefantrine by day 4 post administration of MMV367 and recrudescences allowed identification of the PK/PD relationship. There were no serious adverse events. In summary, this study supports the further clinical development of MMV367 in patients as a single dose treatment of uncomplicated malaria."

Clinical • P1 data • PK/PD data • Infectious Disease • Malaria

Phase 1b MMV367 PK/PD and Safety in Healthy Adult Volunteers Experimentally Infected With Blood Stage P. Falciparum (clinicaltrials.gov) - P1 | N=18 | Completed | Sponsor: Medicines for Malaria Venture | Recruiting ➔ Completed | Phase classification: P1b ➔ P1

Phase classification • Trial completion • Immunology • Infectious Disease • Inflammation • Malaria • Systemic Inflammatory Response Syndrome

A first-in-human (FIH) safety, tolerability, and pharmacokinetics (PK) study of MMV367, a new candidate anti-malarial agent for acute uncomplicated malaria (ASTMH 2023) - P1 | "MMV367 demonstrated safety, tolerability and PK warranting further clinical development. This new candidate will be further tested against induced blood-stage malaria in healthy participants to provide a PK-PD model supporting Phase 2 study design."

Clinical • P1 data • PK/PD data • Infectious Disease • Malaria • Pain

Phase 1b MMV367 PK/PD and Safety in Healthy Adult Volunteers Experimentally Infected With Blood Stage P. Falciparum (clinicaltrials.gov) - P1b | N=18 | Recruiting | Sponsor: Medicines for Malaria Venture

New P1 trial • Immunology • Infectious Disease • Inflammation • Malaria • Systemic Inflammatory Response Syndrome

First-in-Human Study to Assess the Safety, Tolerability and Pharmacokinetics of MMV367 (clinicaltrials.gov) - P1 | N=47 | Completed | Sponsor: Medicines for Malaria Venture | Active, not recruiting ➔ Completed

Trial completion • Infectious Disease • Malaria

First-in-Human Study to Assess the Safety, Tolerability and Pharmacokinetics of MMV367 (clinicaltrials.gov) - P1 | N=47 | Active, not recruiting | Sponsor: Medicines for Malaria Venture | Recruiting ➔ Active, not recruiting | N=72 ➔ 47

Enrollment change • Enrollment closed • Infectious Disease • Malaria

First-in-Human Study to Assess the Safety, Tolerability and Pharmacokinetics of MMV367 (clinicaltrials.gov) - P1 | N=72 | Recruiting | Sponsor: Medicines for Malaria Venture

New P1 trial • Infectious Disease • Malaria