SAR441121 / Sanofi, Medicines for Malaria Venture - LARVOL DELTA

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

Safety, tolerability, pharmacokinetics, and antimalarial activity of MMV533: a phase 1a first-in-human, randomised, ascending dose and food effect study, and a phase 1b Plasmodium falciparum volunteer infection study. (PubMed, Lancet Infect Dis) - P1 | "An acceptable safety and tolerability profile, confirmed parasiticidal activity, and a long half-life support progression of MMV533 into clinical trials in patients with malaria as a component of new antimalarial combination therapies."

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

MMV533, a promising new antimalarial on the horizon. (PubMed, Lancet Infect Dis) - No abstract available

Journal • Infectious Disease

MMV533 Plasmodium Falciparum Volunteer Infection Study (clinicaltrials.gov) - P1 | N=9 | Completed | Sponsor: Medicines for Malaria Venture | Phase classification: P1b ➔ P1

Phase classification • Infectious Disease • Malaria

Safety, tolerability, pharmacokinetics, and antimalarial efficacy of a novel Plasmodium falciparum blood stage inhibitor MMV533: a first-in-human study and a volunteer infection study. (ASTMH 2023) - "All participants given a dose of 100mg effectively cleared their blood stage Pf. Results support further development of MMV533."

Clinical • Late-breaking abstract • P1 data • PK/PD data • Fatigue • Infectious Disease • Malaria • Pain

A focus on sustainable method development for greener synthesis. (PubMed, Chem Sci) - "Sci., 2023, 14, 6399, https://doi.org/10.1039/D3SC01699D) have succinctly demonstrated how employing more sustainable methodology can vastly reduce the environmental impact associated with the synthesis of the antimalarial drug candidate MMV688533. The most notable feature of this newly reported synthetic route is the application of aqueous micellar conditions to two Sonogashira coupling reactions that simultaneously improve the yield, catalyst loading and sustainability of these key steps."

Journal • Infectious Disease

A sustainable, efficient, and potentially cost-effective approach to the antimalarial drug candidate MMV688533. (PubMed, Chem Sci) - "Compared with the first-generation manufacturing process reported by Sanofi, the current route features ppm levels of palladium loading, less material input, less organic solvent, and no traditional amide coupling reagents. The overall yield is improved ten-fold, from 6.4% to 67%."

Cost effectiveness • HEOR • Journal • Infectious Disease

A Phase 1 Study to Assess the Safety, Tolerability, and Pharmacokinetic Profile of a Single Doses of MMV533. (clinicaltrials.gov) - P1 | N=56 | Completed | Sponsor: Medicines for Malaria Venture | Recruiting ➔ Completed

Trial completion • Infectious Disease • Malaria

MMV533 Plasmodium Falciparum Volunteer Infection Study (clinicaltrials.gov) - P1b | N=9 | Completed | Sponsor: Medicines for Malaria Venture | Recruiting ➔ Completed

Trial completion • Infectious Disease • Malaria

A Phase 1 Study to Assess the Safety, Tolerability, and Pharmacokinetic Profile of a Single Doses of MMV533. (clinicaltrials.gov) - P1 | N=56 | Recruiting | Sponsor: Medicines for Malaria Venture | Trial completion date: May 2022 ➔ Sep 2022 | Trial primary completion date: May 2022 ➔ Sep 2022

Trial completion date • Trial primary completion date • Infectious Disease • Malaria

MMV533 Plasmodium Falciparum Volunteer Infection Study (clinicaltrials.gov) - P1b | N=12 | Recruiting | Sponsor: Medicines for Malaria Venture | Not yet recruiting ➔ Recruiting

Enrollment open • Infectious Disease • Malaria

A Phase 1 Study to Assess the Safety, Tolerability, and Pharmacokinetic Profile of a Single Doses of MMV533. (clinicaltrials.gov) - P1 | N=56 | Recruiting | Sponsor: Medicines for Malaria Venture | Trial completion date: Feb 2022 ➔ May 2022 | Trial primary completion date: Dec 2021 ➔ May 2022

Trial completion date • Trial primary completion date • Infectious Disease • Malaria

MMV533 Plasmodium Falciparum Volunteer Infection Study (clinicaltrials.gov) - P1b; N=12; Not yet recruiting; Sponsor: Medicines for Malaria Venture

New P1 trial • Infectious Disease • Malaria

A Phase 1 Study to Assess the Safety, Tolerability, and Pharmacokinetic Profile of a Single Doses of MMV533. (clinicaltrials.gov) - P1; N=56; Recruiting; Sponsor: Medicines for Malaria Venture; Trial primary completion date: Aug 2021 ➔ Dec 2021

Clinical • Trial primary completion date • Infectious Disease • Malaria

The antimalarial MMV688533 provides potential for single-dose cures with a high barrier to Plasmodium falciparum parasite resistance. (PubMed, Sci Transl Med) - "These proteins are implicated in intracellular trafficking, lipid utilization, and endocytosis, suggesting interference with these pathways as a potential mode of action. This preclinical candidate may offer the potential for a single low-dose cure for malaria."

Journal • Infectious Disease • Malaria

A Phase 1 Study to Assess the Safety, Tolerability, and Pharmacokinetic Profile of a Single Doses of MMV533. (clinicaltrials.gov) - P1; N=56; Recruiting; Sponsor: Medicines for Malaria Venture; Not yet recruiting ➔ Recruiting; Trial primary completion date: Sep 2020 ➔ Aug 2021

Clinical • Enrollment open • Trial primary completion date • Infectious Disease • Malaria

A Phase 1 Study to Assess the Safety, Tolerability, and Pharmacokinetic Profile of a Single Doses of MMV533. (clinicaltrials.gov) - P1; N=56; Not yet recruiting; Sponsor: Medicines for Malaria Venture; Trial completion date: Dec 2020 ➔ Dec 2021

Clinical • Trial completion date • Infectious Disease • Malaria

A Phase 1 Study to Assess the Safety, Tolerability, and Pharmacokinetic Profile of a Single Doses of MMV533. (clinicaltrials.gov) - P1; N=56; Not yet recruiting; Sponsor: Medicines for Malaria Venture

New P1 trial