drugset / Trial / NCT05304611

Anti-malaria MAb in Malian Children

Phase 2 Completed 365 enrolled National Institute of Allergy and Infectious Diseases (NIAID) Harvard School of Public Health (HSPH) · collab Indiana University · collab Malaria Research and Training Center, Bamako, Mali · collab National Institutes of Health (NIH) · collab University of Washington · collab University of the Sciences, Techniques and Technologies of Bamako · collab

RandomizedSequentialTriple-blindPrevention

Summary

The purpose of this study is to evaluate the safety and tolerability of onetime subcutaneous (SC) or intravenous (IV) administration of monoclonal antibody (MAb) L9LS in healthy Malian adults and one-time SC administration of L9LS in healthy Malian children, as well as its protective efficacy against naturally occurring Plasmodium falciparum (Pf) infection over a 7-month malaria season in healthy Malian children 6-10 years of age.

Timeline

Start: 2022-03-18
Primary completion: 2024-04-20
Completion: 2024-04-20

Outcome

Met primary endpoint

paper The efficacy of L9LS against P. falciparum infection, as compared with placebo, was 66% (adjusted confidence interval [95% CI], 45 to 79) reads as met primary endpoint PMID 38669354 ↗

paper with the 150-mg dose and 70% (adjusted 95% CI, 50 to 82) with the 300-mg dose (P<0.001 for both comparisons). reads as met primary endpoint PMID 38669354 ↗

release “L9LS, an experimental monoclonal antibody that incorporates Xencor’s Xtend™ Fc Domain, was up to 77% effective in preventing malaria in children in Mali” reads as unknown xencor.com ↗

Publications

Results Kayentao K, Ongoiba A, Preston AC, Healy SA, Hu Z, Skinner J, Doumbo S, Wang J, Cisse H, Doumtabe D, Traore A, Traore H, Djiguiba A, Li S, Peterson ME, Telscher S, Idris AH, Adams WC, McDermott AB, Narpala S, Lin BC, Serebryannyy L, Hickman SP, McDougal AJ, Vazquez S, Reiber M, Stein JA, Gall JG, Carlton K, Schwabl P, Traore S, Keita M, Zeguime A, Ouattara A, Doucoure M, Dolo A, Murphy SC, Neafsey DE, Portugal S, Djimde A, Traore B, Seder RA, Crompton PD; Mali Malaria mAb Trial Team. Subcutaneous Administration of a Monoclonal Antibody to Prevent Malaria. N Engl J Med. 2024 May 2;390(17):1549-1559. doi: 10.1056/NEJMoa2312775. Epub 2024 Apr 26.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	L9LS	Monoclonal antibody	20 mg/kg	Subcutaneous
Subject	L9LS	Monoclonal antibody	150 mg	Subcutaneous
Subject	L9LS	Monoclonal antibody	300 mg	Subcutaneous
Subject	L9LS	Monoclonal antibody	600 mg	Subcutaneous