Delving into the Latest Updates on MMV367 with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

MMV 367, MMV-367

Target-

Action-

Mechanism-

Therapeutic Areas

Infectious DiseasesOther Diseases

Active Indication-

Inactive Indication

Malaria, FalciparumParasitemia

Originator Organization

MMV Medicines for Malaria Venture

Active Organization-

Inactive Organization

Southern Star Research

Swiss BioQuant AG

ICON plc

+ [3]

License Organization-

Drug Highest PhasePendingPhase 1

First Approval Date-

Regulation-

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This is an open-label, adaptive study using the P. falciparum induced blood stage malaria (IBSM) model to characterise the pharmacokinetic/pharmacodynamic (PK/PD) profile and safety of MMV367 (the IMP). Up to 18 participants will be enrolled in cohorts of up to 6 participants each. The study will proceed as follows for all participants:
* Screening period of up to 28 days to recruit healthy adult participants.
* Day 0: Intravenous inoculation with approximately 2,800 viable P. falciparum-infected red blood cells.
* Days 1-3: Daily follow up via phone call or text message.
* Days 4-7: Daily site visits for clinical evaluation and blood sampling to monitor malaria parasite numbers via quantitative polymerase chain reaction (qPCR).
* Day 7 PM: Start of confinement within the clinical trial unit.
* Day 8: Administration of a single oral dose of the IMP (MMV367). Different doses of MMV367 will be administered across and within cohorts in order to effectively characterise the PK/PD relationship.
* Days 8-11: Regular clinical evaluation and blood sampling while confined to monitor malaria parasite numbers and measure MMV367 plasma concentration.
* Day 11 AM: End of confinement within clinical trial unit.
* Days 12-23: Outpatient follow-up for clinical evaluation and blood sampling.
* Day 24: Initiation of compulsory definitive antimalarial treatment with Riamet® (artemether/lumefantrine) and/or other registered antimalarials if required. Treatment will be initiated earlier than Day 24 in the event of:
* Insufficient parasite clearance following IMP dosing
* Parasite regrowth following IMP dosing Characterising the pharmacokinetic/pharmacodynamic relationship of MMV367
* Participant discontinuation/withdrawal,
* Investigator's discretion in the interest of participant safety.
* Day 27: End of study visit for final clinical evaluation and to ensure complete clearance of malaria parasites.

Start Date01 Aug 2023

Sponsor / Collaborator

MMV Medicines for Malaria Venture

[+6]

NCT05507970

/ CompletedPhase 1IIT

A First-in-Human, Single-Centre, Single Ascending Dose, Multiple Dose and Pilot Food Effect Study to Assess the Safety, Tolerability and Pharmacokinetics of MMV367 in Healthy Participants

This three-part, first-in-human, healthy volunteer study aims to assess the safety and tolerability of the test medicine as well as how it is taken up by the body when given as single and multiple doses. The effect of food on the test medicine will also be investigated.
In Part 1, up to 40 volunteers will be split into up to 5 groups and will receive single oral doses of the test medicine or dummy medicine (placebo), at different dose levels.
In Part 2, up to 8 volunteers will receive one oral dose of the test medicine in the fed state and one oral dose in the fasted state.
In Part 3, up to 24 volunteers will be split into up to 3 groups and will receive single oral daily doses of the test medicine or placebo for 3 consecutive days.
Volunteers' blood and urine will be taken throughout the study for analysis of the test medicine and for their safety. In Part 1 and Part 3, volunteers will be discharged from the clinical unit 4 days after the final dose of the test medicine and will return to the clinical unit on two occasions for safety assessments to be performed. In Part 2, volunteers will be discharged from the clinical unit 4 days after the final dose of the test medicine and will return to the clinical unit on a single occasion for safety assessments to be performed. Volunteers are expected to be involved in this study for approximately 6 weeks for all study parts, from screening to the final return visit.

Start Date29 Jul 2022

Sponsor / Collaborator

MMV Medicines for Malaria Venture

[+4]

100 Clinical Results associated with MMV367

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100 Translational Medicine associated with MMV367

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100 Patents (Medical) associated with MMV367

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3

Literatures (Medical) associated with MMV367

01 Jun 2025·BRITISH JOURNAL OF CLINICAL PHARMACOLOGY

First‐in‐human safety, tolerability, pharmacokinetics and pilot food‐effect study of the candidate antimalarial compound MMV367

Article

Author: Gibson, Rachel A. ; Singh, Nand ; Gamo, Francisco‐Javier ; Gossen, Denis ; Chalon, Stephan ; Lambourne, Erin ; Janin, Annick ; Sharma, Raman ; Kuemmerle, Andrea ; Dove, Tom ; Bestgen, Benoit ; Cahn, Anthony ; Menakuru, Somasekhara R. ; Sanz, Laura

Abstract:

Aim:

To evaluate the safety, tolerability and pharmacokinetics in healthy participants of orally administered MMV367 (GSK3772701), a novel antimalarial interfering with Plasmodium falciparum acyl coenzyme A synthetase 10/11 function.

Methods:

This first‐in‐human study enrolled 47 healthy male and female participants. Part 1 was a randomised, double‐blind, placebo‐controlled study in which four sequential fasted cohorts received MMV367 single ascending doses (100, 300, 750 and 1500 mg) or placebo (six active, two placebo per cohort). Part 2 was a randomised, open‐label crossover (fed‐fasted) pilot food‐effect study of MMV367 440 mg (n = 8). In Part 3 MMV367 400 mg was administered once daily for 3 days in a single cohort (six active, two placebo).

Results:

Treatment‐emergent adverse events (TEAEs) occurred in 36.8% (14/38) of participants receiving MMV367 vs 44.4% (4/9) with placebo. There were two MMV367‐related TEAEs, and no serious or severe TEAEs or clinically relevant changes in electrocardiograms, vital signs or laboratory tests. In Part 1 (fasted), maximum plasma concentrations occurred between 2.0 and 5.0 h post dose, with a geometric mean half‐life of 16.5‐18.4 h. Approximate dose proportionality was demonstrated across the dose range (100‐1500 mg). In Part 2, MMV367 relative bioavailability (fed vs fasted) was 161.4% (90% confidence interval 148.3, 175.6) for maximum observed concentration (Cmax), 130.4% (122.2, 139.1) for the area under the curve (AUC) until the last measurable concentration and 132.9% (124.1, 142.3) for AUC extrapolated to infinity. In Part 3, geometric mean day 1:3 exposure ratios (geometric co‐efficient of variability) were 1.9 (4.9%) for Cmax and 2.1 (7.7%) for the AUC for the defined interval between doses after once‐daily dosing for 3 days.

Conclusions:

MMV367 demonstrated acceptable safety, tolerability and pharmacokinetic profiles supporting further development as an antimalarial drug.

01 Jun 2025·CLINICAL MICROBIOLOGY AND INFECTION

The non-artemisinin antimalarial drugs under development: a review

Review

Author: Mombo-Ngoma, Ghyslain ; Zoleko Manego, Rella ; Duparc, Stephan ; Ramharter, Michael ; Kremsner, Peter Gottfried ; Okwu, Dearie Glory

BACKGROUND:

In 2022, malaria caused approximately 249 million cases and 608,000 deaths, primarily in Africa. Current treatments target asexual blood-stage parasites, gametocytes, and liver hypnozoites. Standard guidelines recommend a 3-day course of artemisinin-based combination therapies as a first-line treatment of uncomplicated malaria and parenteral artesunate for severe malaria. However, the emergence of partial resistance to artemisinin derivatives threatens the treatment efficacy, highlighting the urgent need for novel antimalarial drugs.

OBJECTIVES:

This review summarizes recent progress in the clinical development of antimalarials particularly non-artemisinin compounds under target product profile-1.

SOURCES:

Data were gathered from Medicines for Malaria Venture (MMV)'s portfolio and clinical trial databases between 2020 and 2024.

CONTENT:

Sixteen clinical trials were reviewed, including safety and efficacy studies involving healthy volunteers, experimentally infected volunteers, asymptomatic Plasmodium falciparum carriers and malaria patients. Six trials evaluated the safety and tolerability of MMV533, ZY19489, INE963, GSK701/MMV367 and intravenous KAE609 in healthy volunteers. Efficacy trials involving experimentally infected volunteers assessed ZY19489 and GSK701/MMV367, whereas studies on asymptomatic carriers tested ZY19489/ferroquine and cabamiquine/pyronaridine. Trials on malaria patients investigated combinations of ganaplacide/lumefantrine-SDF, cabamiquine/pyronaridine, both oral and intravenous cipargamin and INE963.

IMPLICATIONS:

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 efforts towards malaria control, elimination and, potentially, eradication.

BRITISH JOURNAL OF CLINICAL PHARMACOLOGY

First‐in‐human safety, tolerability, pharmacokinetics and pilot food‐effect study of the candidate antimalarial compound MMV367

Article

Author: Gibson, Rachel A. ; Singh, Nand ; Gamo, Francisco‐Javier ; Gossen, Denis ; Chalon, Stephan ; Lambourne, Erin ; Janin, Annick ; Kuemmerle, Andrea ; Sharma, Raman ; Dove, Tom ; Bestgen, Benoit ; Menakuru, Somasekhara R. ; Cahn, Anthony ; Sanz, Laura

Abstract:

Aim:

To evaluate the safety, tolerability and pharmacokinetics in healthy participants of orally administered MMV367 (GSK3772701), a novel antimalarial interfering with Plasmodium falciparum acyl coenzyme A synthetase 10/11 function.

Methods:

This first‐in‐human study enrolled 47 healthy male and female participants. Part 1 was a randomised, double‐blind, placebo‐controlled study in which four sequential fasted cohorts received MMV367 single ascending doses (100, 300, 750 and 1500 mg) or placebo (six active, two placebo per cohort). Part 2 was a randomised, open‐label crossover (fed‐fasted) pilot food‐effect study of MMV367 440 mg (n = 8). In Part 3 MMV367 400 mg was administered once daily for 3 days in a single cohort (six active, two placebo).

Results:

Treatment‐emergent adverse events (TEAEs) occurred in 36.8% (14/38) of participants receiving MMV367 vs 44.4% (4/9) with placebo. There were two MMV367‐related TEAEs, and no serious or severe TEAEs or clinically relevant changes in electrocardiograms, vital signs or laboratory tests. In Part 1 (fasted), maximum plasma concentrations occurred between 2.0 and 5.0 h post dose, with a geometric mean half‐life of 16.5‐18.4 h. Approximate dose proportionality was demonstrated across the dose range (100‐1500 mg). In Part 2, MMV367 relative bioavailability (fed vs fasted) was 161.4% (90% confidence interval 148.3, 175.6) for maximum observed concentration (Cmax), 130.4% (122.2, 139.1) for the area under the curve (AUC) until the last measurable concentration and 132.9% (124.1, 142.3) for AUC extrapolated to infinity. In Part 3, geometric mean day 1:3 exposure ratios (geometric co‐efficient of variability) were 1.9 (4.9%) for Cmax and 2.1 (7.7%) for the AUC for the defined interval between doses after once‐daily dosing for 3 days.

Conclusions:

MMV367 demonstrated acceptable safety, tolerability and pharmacokinetic profiles supporting further development as an antimalarial drug.

100 Deals associated with MMV367

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Parasitemia	Phase 1	Australia	GSK Plc	01 Aug 2023
Parasitemia	Phase 1	Australia	ICON plc	01 Aug 2023
Parasitemia	Phase 1	Australia	Southern Star Research	01 Aug 2023
Parasitemia	Phase 1	Australia	MMV Medicines for Malaria Venture	01 Aug 2023
Parasitemia	Phase 1	Australia	Swiss BioQuant AG	01 Aug 2023
Malaria, Falciparum	Phase 1	United Kingdom	MMV Medicines for Malaria Venture	29 Jul 2022
Malaria, Falciparum	Phase 1	United Kingdom	The Doctors Laboratory Ltd.	29 Jul 2022
Malaria, Falciparum	Phase 1	United Kingdom	Swiss BioQuant AG	29 Jul 2022
Malaria, Falciparum	Phase 1	United Kingdom	GSK Plc	29 Jul 2022

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05507970 (CTgov)	Phase 1	Malaria, Falciparum	47	MMV367 (Part 2 Food Effect Fed 440mg)	qtucexbzic = vuuvqicnmw wkqpwdogqp (cvgctvifvh, jpqjmiarfc - ealhusfrpr) View more	-	29 Jan 2025
				MMV367 (Part 2 Food Effect Fasted 440mg)	qtucexbzic = xqkajwjckw wkqpwdogqp (cvgctvifvh, nsryhojutu - mouoaakder) View more