The SINDOFO project main goal is to develop a new non-ACT-based antimalarial drug combination with a shortened, ideally single dose regimen to help reduce morbidity and mortality due to malaria in adults, adolescents, and most importantly, in children in Africa under the age of 5, who are the most vulnerable group with the highest number of deaths (2/3 of malaria deaths in 2019).
Previous clinical trial has shown that ferroquine (FQ) has a great potential as combination partner in the single dose or short antimalarial regimen combination therapy. In addition, it presents favourable CMC (chemistry, manufacturing and controls) characteristics.
The SINDOFO consortium is dedicated to developing a novel FQ-based combination therapy to treat malaria in African children. A very promising partner has been identified: ZY19489 (also known as ZY19489), a fast-acting drug that is proposed as a combination partner for FQ to be developed in a single or short regimen as an alternative to ACTs.
The SINDOFO consortium will focus on a phase II multicenter clinical trial performed at 4 African sites, namely CERMEL (Gabon), FM-CISM (Mozambique), Ahero (Kenya), and CNRST-IRSS (Burkina Faso).
Each African trial site and the University of Tübingen will take on a postdoc and a PhD student for capacity building. This will allow to qualify and further support African research and leadership at these sites.
Ferroquine (FQ) was designed in 1994, it is a 4-aminoquinoline with a ferrocene bond active against Plasmodium falciparum-resistant to chloroquine. It has a half-life ranging from 14 to 24 days and a longer lasting active metabolite, SSR97213, with a half-life ranging from 24 to 52 days. FQ´s mode of action is likely similar to that of chloroquine, inhibiting the heme detoxification process in the digestive vacuole of the parasite.
ZY19489 (also known as MMV253) was selected as a development candidate in September 2014. It has a half-life of around 80 hours and is active against blood-stages of P. falciparum and P. vivax. It is the fast-acting drug in the combination, killing P. falciparum with a similar parasite reduction ratio to mefloquine, and presents low resistance potential.
FQ and ZY19489 have independent mechanism of action and the combination of the two compounds gives one of the most promising predictions of a combined treatment against malaria, ideally in a single dose regimen, helping to reduce morbidity and mortality caused by this disease.
Co-leader of WP6: Capacity building.
Quique Bassat is a pediatrician with special interest in infectious disease epidemiology and public health. His main area of interest has been the prevention and treatment of malaria in childhood, with a particular focus on understanding the clinical overlap of malaria and other common pediatric conditions.
His research has also covered the new paradigm of malaria eradication, with a particular interest in evaluating the role of drugs in elimination strategies. Dr Bassat is an ICREA research professor at the Barcelona Institute for Global Health (ISGlobal) and a senior researcher at the Centro de Investigação em Saúde de Manhiça (CISM)
Vice President, Head of Program Leadership and Strategy in the Product Development department at Medicines for Malaria Venture, based in Geneva, Switzerland.
She has 20 years of experience working in the Pharmaceutical industry with increasing responsibilities starting at GSK, followed by Serono, Merck Serono, and lastly MMV.
She joined MMV in 2012, and she is now leading the group of Project Directors in the Product Development department steering and overseeing the development of new antimalarials for treatment and prevention from First-in-Human to registration. She has brought herself as Project Director two compounds from preclinical to Phase II patient study. She is part of the Portfolio Strategy Management Board at MMV, and she is a mentor in the H3D Global Health Mentorship Program.
Cristina holds a PharmD from the Faculty of Pharmacy, University of Parma, Italy, and a PhD in Biopharmaceuticals from University of Parma, in joint collaboration with Purdue University, West Lafayette, IN, USA.
CNRST-IRSS, Burkina Faso
Leader of WP4: Clinical trial – Burkina Faso.
Pharm D by background, he worked from 1995 to 1999 as research associate in Centre Muraz, Burkina Faso, where he obtained his Postgraduate Advanced Diploma in biochemistry & microbiology in 1998. He has been involved in several projects related to the epidemiological surveillance of malaria drug resistance.
From 1999 to 2000, He worked at the Royal Danish School of Pharmacy, Denmark, as research fellow in development of alternative medicine against malaria. In 2001, he was recruited as research associate at the Institute for Health Sciences Research (IRSS) in Burkina Faso. From 2003 to 2006, he worked as PhD fellow in medical sciences at ITM, Belgium, where he studied the epidemiology of malaria drug resistance in Burkina Faso and the mechanisms of resistance in Rwanda.
After obtaining his PhD in 2006, he went back to Burkina Faso, where he created in 2009 the Clinical Research Unit of Nanoro, where over 250 people are working on several projects. So far, the unit has successfully conducted several clinical trials at ICH/GCP standards including the more recent R21 malaria vaccine candidate phase II trial. From 2013 to 2014, he worked as scientific director of Centre Muraz. In 2016, he became Director of Research and was awarded the Professorship in Parasitology at the Faculty of Medicine of the Nazi Boni University of Bobo-Dioulasso, Burkina Faso. In 2017, he was appointed as Regional Director of IRSS in Nanoro. He is author and co-author of 199 articles published in peer-reviewed journals and co-author of two books.
Leader of WP2: Clinical trial – Gabon.
Professor Ghyslain Mombo-Ngoma is the head of clinical operations at the Centre de Recherches Médicales de Lambaréné (CERMEL), Gabon and professor at the Bernhard Nocht Institute for Tropical Medicine (BNITM) and the University Medical Centre Hamburg-Eppendorf (UKE) in Germany. He has a medical doctor degree from the medical university of Gabon (USS) and was trained in epidemiology and clinical trials at the London School of Hygiene and Tropical Medicine (LSHTM), UK and obtained a PhD from the University of Leiden, Netherlands.
Professor Mombo-Ngoma has a track record of conducting phase I to phase IV clinical trials in the field of malaria and other poverty related infectious diseases and he is leading a dedicated multidisciplinary and multinational team of clinical researchers with key research interests on maternal and child and adolescent health and the development and implementation of medicines for poverty related infectious diseases.
Strathmore University, Kenya
Leader of WP5: Clinical trial – Kenya.
Bernhards Ogutu is the Chief Research Officer of the Kenya Medical Research Institute (KEMRI) and Director of Centre for Research in Therapeutic Sciences (CREATES), Strathmore University, Kenya.
He is a pediatrician and clinical pharmacologist and has extensive experience in clinical research. He was involved, among others, in the following clinical trials: a phase II of MSP1 malaria vaccine candidate supported by a grant from the PATH-MVI at Kombewa in Kisumu, RTS,S phase II and III vaccine trials in adults and children, and optimization of IV artesunate in African children funded by EDCTP.
He has authored more than 50 peer reviewed publications and obtained his MBChB (1992), MMed (1998) and Ph.D (2002) at the Nairobi University, Kenya.
Leader of WP3: Clinical trial - Mozambique
Jéssica Dalsuco works at the Health Research Center of Manhiça in biomedical research since 2022. Focused in Malaria and also in Respiratory Infections and TB. Provides support to the clinical area as a Physician in the Neonatology and Pediatrics Emergency Department.
She has a degree in General Medicine from Higher Institute of Science and Technology of Mozambique since 2017, a Post-graduate degree in Neonatal Medicine from Portuguese Catholic University in Portugal since 2020 and a Master's degree in Cardiovascular Physiopathology from University of Porto in Portugal since 2020.
Currently doing her PhD in Medicine and Translational Research at ISGlobal, University of Barcelona.
Dr. Jana Held
Coordinator and Leader of WP1: Coordination.
Jana Held is a research group leader at the ITM at the University Tübingen dedicated to malaria research since more than 15 years.
She studied Biology at the University Bochum, Germany conducting her thesis at the University Zürich and UCD Dublin. She obtained her PhD degree at the University of Tübingen on the preclinical development of novel antimalarial compounds. In addition, she received a Diploma in Business Administation and Economics for scientists at the Fernuniversität Hagen. After research stays at the Centre de Recherches Médicales de Lambaréné (CERMEL), Gabon, she has now her own research group at ITM Tübingen focusing on the discovery of novel antimalarial compounds and the biology of nonfalciparum species.