MMV390048 POC in Patients With P. Vivax and P. Falciparum Malaria

Summary

The present proof-of-concept Phase IIa study aims to confirm, in patients, the observed activity of MMV390048 against P. falciparum in pre-clinical models and the human Induced Blood-Stage Malaria (IBSM) challenge model, and to determine the activity against P. vivax malaria in patients, both over 14 and 28 days. Additional aims are to characterise the safety of MMV390048 in patients. Patient safety will be monitored for up to 35 days post-dose including pharmacokinetic assessments. The study will investigate descending single doses of MMV390048 in response to results obtained in the first cohort/dose in each malaria sub-type. The results of this trial will identify active, well-tolerated doses for investigation in combination with a partner drug within a Phase IIb clinical trial.

Timeline

Start

2017-10-20

Primary completion

2018-01-01

Completion

2018-09-24

Outcome

Outcome not reported

Stopped (Business): “Due to a Medicines for Malaria Venture (MMV) strategic business decision”

Publications

• Mohammed R, Asres MS, Gudina EK, Adissu W, Johnstone H, Marrast AC, Donini C, Duparc S, Yilma D. Efficacy, Safety, Tolerability, and Pharmacokinetics of MMV390048 in Acute Uncomplicated Malaria. Am J Trop Med Hyg. 2022 Dec 5;108(1):81-84. doi: 10.4269/ajtmh.22-0567. Print 2023 Jan 11.

Drugs

Indications