A Multi-Part, Multi-Center PLATform Study to Assess the Efficacy, Safety, Tolerability and Pharmacokinetics of Anti-Malarial Agents Administered as Monotherapy and/or Combination Therapy IN Patients with Uncomplicated Plasmodium Falciparum Malaria (PLATINUM)

December 29, 2024 | Ongoing Project | Reading time: 7 min

Introduction
This PLATINUM drug trial is a two-year Phase 2A study that is carried out to test how effective, safe, and tolerable different anti-malarial drugs are, including their behavior in the body, for treating uncomplicated Plasmodium falciparum malaria. Using both single-drug and combination therapies, the PLATINUM trial seeks to tackle major challenges like drug-resistant malaria to help improve malaria treatments in countries most affected by malaria.

Investigators

Dr. Samuel Harrison, Dr. Kwaku Poku Asante, Dr. Seyram Kaali, Dr. Felicia Serwah, Dr. Anthony Siibu.

Background

Malaria remains a critical health challenge worldwide, responsible for 241 million cases and 627,000 deaths in 2020 alone, with the highest burden in sub-Saharan Africa where P. falciparum and P. vivax cause most malaria cases. Following a mosquito bite, Plasmodium parasites initially infect the liver and subsequently invade red blood cells, leading to symptoms such as fever, headaches, and muscle aches. If untreated, infections can escalate to severe malaria, with complications such as coma, respiratory distress, and severe anaemia, posing a risk of death, especially in young children under five who accounted for 67% of malaria deaths in 2020.

Although Artemisinin Combination Therapies ACTs remain effective in many regions, resistance to artemisinin-based drugs has been recorded. In response, efforts to develop new anti-malarial agents focus on targeting resistant strains, enhancing efficacy, and reducing treatment complexity. The Medicines for Malaria Venture (MMV) has outlined a target profile for these agents: they should be highly effective against resistant strains, safe for children and pregnant women, administered in a short regimen, cost-effective, and stable in tropical climates. The goal is to achieve a one-dose cure in combination therapy to increase compliance and minimize resistance risk.

Given the significance of the infection, the potential long-term consequences for the survivors and number of people at risk of this disease, it is important we find a vaccine to help protect against the disease.

Objective
The objectives of the study include:

1. To assess how long it takes for the new antimalarials to cure malaria as combination therapy versus the standard of care in patients with uncomplicated P. falciparum malaria.

2. To assess the safety and tolerability of each anti-malarial agent administered orally as monotherapy and/or as combination therapy [Part B] in patients with uncomplicated P. falciparum malaria.

Study Methodology

This study is being conducted at several sites across countries in West, East, and Central Africa. It has two parts: Part A and Part B. Part A will test anti-malarial drugs when used alone, while Part B will focus on testing these drugs in combination.

KHRC is involved in Part B, which plans to enroll about 60 participants. Participants will be randomly assigned to receive either a combination of two medications (KAE609 and KLU156) or COARTEM. The medication doses will be based on each participant's body weight.

Participants diagnosed with malaria through confirmed tests at health facilities in the study area will be approached, and the study will be explained to them. Those who agree to join the study will be transported to the study clinic, where they will go through consent and screening procedures. Participants who pass screening will be entered into a randomization system to determine their treatment group. They will stay at the study clinic for three days for specific procedures, with follow-up activities scheduled as outpatients on specific days through to Day 43.

Expected Outcome
This study is expected to find new antimalarial agents that are effective and safer to be used in further studies.

Funders: Novartis Pharma AG

Study Duration: Twenty-One (21) Months

Start Date: March 2024

End Date: June 2025