This study will assist in the development of an advanced candidate compound from the antimalarial drug pipeline developed by MMV and partners. The compound is being studied as a potential long-acting injectable chemoprotective.
The primary objective of the trial is to test the efficacy MMV's experimental compound in killing malaria parasites in the liver before they can develop and reach the bloodstream, thus protecting people from malarial disease. The trial will be conducted in SGS's dedicated 20-bed unit at Antwerp's Stuivenberg Hospital under a high level of safety and supervision.
"SGS is very proud to contribute to the global health effort to defeat malaria in the world. The malaria parasite killed 435,000 people in 2017 and infected an estimated 219 million. Fifty per cent of the world's population are living in over 90 countries where malaria transmission occurs.1 91% of the deaths are in Africa in predominantly low-income regions. Young children and pregnant women form an especially vulnerable group, associated with a high rate of mortality and as such urgently need novel treatments. This has led to a decision by SGS to step into the field of antimalarial drug development," commented Adrian Wildfire, Project Director, Infectious Diseases and Human Challenge Unit at SGS.
Dr. Pieter-Jan Berghmans, Investigator at SGS and Principal Investigator of this trial, continued: "As there is a continued risk of resistance to currently marketed drugs, developing new anti-malarial drugs is a high priority."
"MMV and its partners have taken a leadership role in finding new ways to accelerate the development of new medicines to treat and prevent malaria. The compound has demonstrated potential to target malaria parasites before they have a chance to establish the symptoms of malaria, and therefore could help protect children from getting sick. In collaboration with SGS this potential will be tested in human subjects for the first time," said Dr. Timothy Wells, MMV's Chief Scientific Officer.
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About the Volunteer Infection Study
SGS's Human Challenge Unit provides level 2 containment and has full isolation capabilities for participants. The VIS trial will involve the intravenous inoculation of 24 healthy volunteers (divided over 2 cohorts of 12 subjects) with living, infectious, cryopreserved malaria parasites. Approved antimalarial drugs will be given to any subject who is diagnosed as malaria positive through a highly sensitive blood test to ensure rapid parasite clearance, thus eliminating the risk of them developing symptoms or transmissible disease in both the placebo and the active drug arms of the study. During the containment period (days 1 to 13 following inoculation) subjects will be closely monitored by resident medical and clinical staff. From day 14 until day 28, daily ambulatory visits to the CPU will allow safety measures to be undertaken.
At the "end-of-trial" (EOT) a last follow up visit will be scheduled (at day 35) to review subject safety prior to discharge. Should MMV's experimental compound be observed to achieve its endpoints (following statistical analysis of the safety and efficacy data) a further titration study to determine the optimal dose of medication will be undertaken at the end of 2019.
SGS is the world's leading inspection, verification, testing and certification company. SGS is recognized as the global benchmark for quality and integrity. With more than 97,000 employees, SGS operates a network of over 2,600 offices and laboratories around the world.
SGS is a leading life sciences CRO providing clinical research, bioanalytical, biologics characterization, biosafety, and quality control testing. Delivering solutions in Europe and the US, SGS offers clinical trial (phase I to IV) services encompassing clinical project management and monitoring, biometrics, PK/PD modeling and simulation, and regulatory and medical affairs consultancy. SGS has its own clinical unit in Belgium and two phase I patient units based in Belgium and Hungary.
SGS has a wealth of expertise in first in human (FIH) studies, human challenge testing, manufacturing challenge agents, biosimilars and complex PK/PD studies with a focus on infectious diseases, vaccines and respiratory therapeutics.
1 Global Health Institute, Antwerp University