CLINICAL TRIALS PROFILE FOR LARIAM

All Clinical Trials for LARIAM

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT01430351 ↗	Temozolomide, Memantine Hydrochloride, Mefloquine, and Metformin Hydrochloride in Treating Patients With Glioblastoma Multiforme After Radiation Therapy	Active, not recruiting	National Cancer Institute (NCI)	Phase 1	2011-09-14	This phase I trial studies the side effects and best dose of combination chemotherapy in treating patients with glioblastoma multiforme after radiation therapy. Drugs used in chemotherapy, such as temozolomide, memantine hydrochloride, and metformin hydrochloride, work in different ways to stop the growth of tumor cells, either by killing them or stopping them from dividing. Mefloquine may help temozolomide, memantine hydrochloride, and metformin hydrochloride kill more cancer cells by making tumor cells more sensitive to the drug. Giving more than one drug (combination chemotherapy) may kill more tumor cells.
NCT00701961 ↗	Pharmacokinetic of Mefloquine-Artesunate in Plasmodium Falciparum Malaria Infection in Pregnancy	Completed	Centre Muraz	Phase 2/Phase 3	2008-10-01	Malaria in pregnancy is a major public health problem in Sub-Saharan Africa. Over the past decades, P. falciparum has shown increasing resistance to chloroquine and Sulphadoxine-Pyrimethamine, which has prompted a change in treatment approach; artemisinin containing combination therapies (ACTs) are now the standard treatment of P. falciparum malaria in areas with established resistance to traditional therapies. However, a standard approach for using ACT in pregnancy does not exist in Africa, where some countries keep on using quinine, while others allow the use of ACTs. Thus, there is need of establishing the safety and efficacy of ACTs in malaria-infected pregnant women. Since the pharmacokinetic of antimalarials may be altered during pregnancy and since available pharmacokinetic data are still somewhat limited, we propose to carry out a study confirming or disproving existing pharmacokinetic data (collected in South-East Asia), before starting any larger African efficacy and safety trials. The fixed-dose combination mefloquine-artesunate (MQ-AS), developed by the Drugs for Neglected Diseases Initiative, will be used in the study, which will compare the pharmacokinetics of MQ-AS for treatment of P.falciparum in 24 pregnant women in the second and third trimesters, to the pharmacokinetics of this regimen in 24 matched non-pregnant P.falciparum infected women. The study will be carried out in Burkina Faso.
NCT00701961 ↗	Pharmacokinetic of Mefloquine-Artesunate in Plasmodium Falciparum Malaria Infection in Pregnancy	Completed	Liverpool School of Tropical Medicine	Phase 2/Phase 3	2008-10-01	Malaria in pregnancy is a major public health problem in Sub-Saharan Africa. Over the past decades, P. falciparum has shown increasing resistance to chloroquine and Sulphadoxine-Pyrimethamine, which has prompted a change in treatment approach; artemisinin containing combination therapies (ACTs) are now the standard treatment of P. falciparum malaria in areas with established resistance to traditional therapies. However, a standard approach for using ACT in pregnancy does not exist in Africa, where some countries keep on using quinine, while others allow the use of ACTs. Thus, there is need of establishing the safety and efficacy of ACTs in malaria-infected pregnant women. Since the pharmacokinetic of antimalarials may be altered during pregnancy and since available pharmacokinetic data are still somewhat limited, we propose to carry out a study confirming or disproving existing pharmacokinetic data (collected in South-East Asia), before starting any larger African efficacy and safety trials. The fixed-dose combination mefloquine-artesunate (MQ-AS), developed by the Drugs for Neglected Diseases Initiative, will be used in the study, which will compare the pharmacokinetics of MQ-AS for treatment of P.falciparum in 24 pregnant women in the second and third trimesters, to the pharmacokinetics of this regimen in 24 matched non-pregnant P.falciparum infected women. The study will be carried out in Burkina Faso.
NCT00701961 ↗	Pharmacokinetic of Mefloquine-Artesunate in Plasmodium Falciparum Malaria Infection in Pregnancy	Completed	Institute of Tropical Medicine, Belgium	Phase 2/Phase 3	2008-10-01	Malaria in pregnancy is a major public health problem in Sub-Saharan Africa. Over the past decades, P. falciparum has shown increasing resistance to chloroquine and Sulphadoxine-Pyrimethamine, which has prompted a change in treatment approach; artemisinin containing combination therapies (ACTs) are now the standard treatment of P. falciparum malaria in areas with established resistance to traditional therapies. However, a standard approach for using ACT in pregnancy does not exist in Africa, where some countries keep on using quinine, while others allow the use of ACTs. Thus, there is need of establishing the safety and efficacy of ACTs in malaria-infected pregnant women. Since the pharmacokinetic of antimalarials may be altered during pregnancy and since available pharmacokinetic data are still somewhat limited, we propose to carry out a study confirming or disproving existing pharmacokinetic data (collected in South-East Asia), before starting any larger African efficacy and safety trials. The fixed-dose combination mefloquine-artesunate (MQ-AS), developed by the Drugs for Neglected Diseases Initiative, will be used in the study, which will compare the pharmacokinetics of MQ-AS for treatment of P.falciparum in 24 pregnant women in the second and third trimesters, to the pharmacokinetics of this regimen in 24 matched non-pregnant P.falciparum infected women. The study will be carried out in Burkina Faso.
NCT00761020 ↗	Merozoite Surface Protein 1 Antibody Response in Asymptomatic Human Malaria Infection	Completed	Walter Reed Army Institute of Research (WRAIR)	N/A	2008-09-01	The main purpose of this trial is to study whether a certain blood test can reliably identify the presence of malaria in people who have been infected with, but who do not have symptoms of malaria.
NCT00761020 ↗	Merozoite Surface Protein 1 Antibody Response in Asymptomatic Human Malaria Infection	Completed	U.S. Army Medical Research and Development Command	N/A	2008-09-01	The main purpose of this trial is to study whether a certain blood test can reliably identify the presence of malaria in people who have been infected with, but who do not have symptoms of malaria.

Clinical Trial Conditions for LARIAM

Condition Name

Condition Name for LARIAM
Intervention	Trials
Supratentorial Glioblastoma	1
Brain Cancer	1
Glioblastoma	1
Gliosarcoma	1

Condition MeSH

Condition MeSH for LARIAM
Intervention	Trials
Malaria	2
Malaria, Falciparum	1
Infections	1
Infection	1

Clinical Trial Locations for LARIAM

Trials by Country

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−

Trials by Country for LARIAM
Location	Trials
United States	2
Burkina Faso	1

Trials by US State

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−

Trials by US State for LARIAM
Location	Trials
Texas	1
Maryland	1

Clinical Trial Progress for LARIAM

Clinical Trial Phase

Clinical Trial Phase for LARIAM
Clinical Trial Phase	Trials
Phase 2/Phase 3	1
Phase 1	1
N/A	1

Clinical Trial Status

Clinical Trial Status for LARIAM
Clinical Trial Phase	Trials
Completed	2
Active, not recruiting	1

Clinical Trial Sponsors for LARIAM

Sponsor Name

Sponsor Name for LARIAM
Sponsor	Trials
National Cancer Institute (NCI)	1
M.D. Anderson Cancer Center	1
Centre Muraz	1

Sponsor Type

Sponsor Type for LARIAM
Sponsor	Trials
Other	4
U.S. Fed	2
NIH	1

Clinical Trials, Market Analysis, and Projections for Anti-Malarial Drugs: Focus on Long-Acting Injectables

Introduction to Anti-Malarial Drugs and Clinical Trials

The fight against malaria has been ongoing for decades, with various strategies and treatments being developed to combat this deadly disease. Recent advancements in clinical trials, particularly for long-acting injectable (LAI) anti-malarial drugs, hold significant promise. Here, we will delve into the current state of clinical trials, market analysis, and future projections for these innovative treatments.

The Need for Innovative Anti-Malarial Treatments

Malaria remains a major global health issue, with millions of cases and thousands of deaths reported annually. Traditional treatments, such as oral medications and vaccines, have limitations, including compliance issues, resistance to drugs, and the need for frequent administration. This necessitates the development of new, more effective, and convenient treatments[5].

Clinical Trials Update: Long-Acting Injectables

MMV371: A Breakthrough in Malaria Prevention

A significant development in the field of anti-malarial treatments is the clinical trial of MMV371, a long-acting injectable preventive compound. Conducted by Medicines for Malaria Venture (MMV) and Quotient Sciences, this trial marks the first clinical evaluation of an LAI for malaria prevention.

• Trial Details: The first-in-human study is being conducted in healthy male and female volunteers in Nottingham, UK. The injectable is designed to provide up to 3 months of protection against all types of malaria, including P. vivax and P. falciparum[1].
• Potential Impact: If successful, this LAI could be a game-changer, offering an affordable and long-lasting option to protect people of all ages from malaria. It is particularly aimed at regions where seasonal malaria chemoprevention (SMC) campaigns are challenging due to parasite resistance[1].

Market Analysis for Anti-Malarial Drugs

Current Market Size and Growth

The global anti-malarial drugs market was valued at USD 989.7 million in 2023 and is expected to grow at a compound annual growth rate (CAGR) of 4.26% from 2024 to 2030. This growth is driven by the persistent global burden of malaria and continuous efforts to develop innovative treatments[5].

Drivers of Market Growth

• High Prevalence of Malaria: The ongoing high incidence of malaria cases and deaths globally drives the demand for effective treatments.
• Innovative Treatments: The development of new drug combinations, formulations, and delivery methods, such as LAIs, contributes to market growth.
• Regulatory Approvals: Regulatory approvals for novel anti-malarial drugs and expanded indications further boost the market[5].

Projections for Long-Acting Injectables

Affordability and Broad Reach

The LAI under development is intended to be affordable and accessible to all age groups, especially young and school-aged children, who are at the highest risk of malaria infection and death. Its single-dose administration and ability to prevent malaria cases and treat asymptomatic infections make it a potential game-changer for global malaria elimination efforts[1].

Clinical Trials and Regulatory Pathway

Pending positive outcomes of the current trial, clinical trials in malaria-endemic countries are expected to begin in 2026. The final product could complement existing interventions such as vaccines and SMC, offering a vital tool for broad populations and multiple malaria strains[1].

Comparison with Other Clinical Trials

While the focus here is on anti-malarial LAIs, other clinical trials in different therapeutic areas also highlight the importance of innovative drug delivery methods. For instance, Larimar Therapeutics is conducting clinical trials for nomlabofusp, a treatment for Friedreich’s ataxia, which involves subcutaneous injections and has shown promising results in Phase 2 trials. However, these trials are distinct in their therapeutic focus and delivery mechanisms[4].

Global Clinical Trials Market Context

The global clinical trials market is projected to grow significantly, driven by the increasing demand to treat chronic diseases. The market size is expected to grow from $61.58 billion in 2024 to $106.78 billion by 2032, at a CAGR of 7.1%. This growth underscores the broader trend of increased investment in clinical research and development, which benefits the development of innovative treatments like LAIs for malaria[3].

Challenges and Considerations

Regulatory and Clinical Challenges

Clinical trials face various challenges, including regulatory hurdles, the need for robust clinical data, and the potential impact of public health crises on trial timelines and operations. For example, Larimar Therapeutics’ nomlabofusp development program highlights the importance of FDA interactions and the need for supplementary nonclinical and clinical data to support accelerated approval applications[4].

Economic and Public Health Factors

The success of clinical trials and the subsequent market adoption of new treatments are influenced by economic conditions and public health policies. The affordability and accessibility of treatments, especially in resource-limited settings, are critical factors in their adoption and impact[1].

Key Takeaways

• Innovative Treatments: Long-acting injectables like MMV371 represent a significant advancement in malaria prevention, offering up to 3 months of protection.
• Market Growth: The anti-malarial drugs market is expected to grow at a CAGR of 4.26% from 2024 to 2030, driven by the high prevalence of malaria and the development of new treatments.
• Clinical Trials: Ongoing and planned clinical trials in malaria-endemic countries will be crucial for the approval and adoption of LAIs.
• Regulatory and Economic Factors: Regulatory approvals, affordability, and accessibility will play key roles in the success of these treatments.

FAQs

What is the current status of the MMV371 clinical trial?

The MMV371 clinical trial is currently in its first-in-human phase, being conducted in healthy male and female volunteers in Nottingham, UK. The trial aims to evaluate the safety and efficacy of the long-acting injectable for malaria prevention[1].

How does the MMV371 LAI differ from traditional anti-malarial treatments?

The MMV371 LAI offers up to 3 months of protection against all types of malaria, which is a significant improvement over traditional oral medications that require frequent administration. It also addresses the issue of drug resistance and compliance[1].

What is the projected market size for anti-malarial drugs by 2030?

The global anti-malarial drugs market is expected to grow at a CAGR of 4.26% from 2024 to 2030, reaching a projected size of over USD 1.3 billion by 2030[5].

What are the key drivers of the anti-malarial drugs market?

The key drivers include the high prevalence of malaria, continuous efforts to develop innovative treatments, regulatory approvals for novel drugs, and initiatives for malaria control and elimination[5].

How do long-acting injectables fit into the broader strategy for malaria elimination?

Long-acting injectables like MMV371 are intended to complement existing interventions such as vaccines and seasonal malaria chemoprevention (SMC), offering a long-lasting and affordable solution for broad populations and multiple malaria strains[1].

Sources

1. Medicines for Malaria Venture. "First-ever long-acting injectable for malaria prevention administered in clinical trial." October 28, 2024.
2. Larimar Therapeutics. "Larimar Therapeutics Reports Second Quarter 2024 Operating and Financial Results." August 7, 2024.
3. Fortune Business Insights. "Clinical Trials Market SIZE, SHARE | GROWTH REPORT [2032]."
4. Larimar Therapeutics. "Larimar Therapeutics Reports Positive Top-line Data from Phase 2 Dose-Ranging Study of Nomlabofusp." February 12, 2024.
5. Grand View Research. "Anti-malarial Drugs Market Size, Share, Growth Report, 2030."