DNDi presents results of Phase III clinical trials at Marseille conference
As part of its quest to develop new and simplified treatments for neglected diseases, the Drugs for Neglected Diseases Initiative today presented the final results of the pivotal Phase III clinical studies for a new malaria treatment. The results show that the new fixed dose combination of artesunate/mefloquine (AS/MQ) is as effective as the existing separate tablets and is better tolerated with a lower incidence of early vomiting. Because of the reduction of the number of tablets as well as the simplification of the regimen, the new product is more convenient for the patients and the prescribers. The results were reviewed at the Medicine and Health in the Tropics Conference in Marseille, France. The AS/MQ Fixed Dose Combination will be available to patients in 2006.
Because of increasing resistance to antimalarials, the World Health Organisation (WHO) and national programmes recommend the use of drug combinations combining two antimalarials, one of which should be a derivative of artemisinin. The use of AS/MQ combinations for malaria treatment is particularly recommended in South East Asia and several countries of Latin-America.
Good efficacy and safety profile
The results of the 500 patient Phase III clinical studies, show that the cure rate at day 63 for patients taking the new FDC’s and existing separate tablet formulations is very high and similar in both groups, – 94.1% for the new FDC and 92.0% for the separate tablet formulation. The study included infants, children and adults and was conducted in Thailand.
Both the new FDC and the existing separate tablet formulation have similar safety profiles, with low and comparable rates of minor side effects like: dizziness, lack of appetite, headaches and sleep disturbance. The most commonly reported side effect for mefloquine – early vomiting, is lower for the FDC (3%) than in the separate tablet formulation (8.4%).
Easier to us
To improve patient adherence and to lessen the risks of resistance, the use of medicines should be as simple as possible. The new formulation will ensure that one adult treatment is limited to two tablets per day once a day for three days, instead of the existing separate tablet formulation of four to seven tablets per day in varying combinations for three days.
A paediatric formulation for infants and children was also tested. The fixed-dose combination avoids the risk of the patient taking just one type of tablet and hence just one of the active ingredients of the combination.
The Phase III study was conducted for DNDi in Thailand during the first six months of 2005 by the Shoklo Malaria Research Unit, part of the faculty of Tropical Medicine of Mahidol University, Thailand. The co-formulation has been developed by Far-Manguinhos in Brazil.
Two new malaria treatments in 2006
DNDi’s FACT (Fixed dose Artesunate based Combination Therapy) project aims to develop two new artesunate-based formulations: artesunate/amodiaquine and artesunate/mefloquine. These drug combinations should be available in 2006 at an affordable price.
“This is good news for patients and for the fight against malaria as this new fixed drug combination is effective, safe, easier to use and better tolerated than the loose formulations.” said Prof Nick White, Professor of Tropical Medicine at Oxford University.
“The world urgently needs a new, easy to use, safe and effective drug against malaria. These results will ensure that this new product will be available by 2006 to the poorest of the poor and that it is adapted to their needs“ said Dr Bernard Pecoul, Executive Director of DNDI
The FACT anti-malaria programme – Fixed-dose Artesunate based Combination Therapy – received financial support from Médecins Sans Frontières, WHO/Tropical Diseases Research and the European Union’s international cooperation programme (INCO/DEV). The success of the project fulfils DNDi’s ambition to bring together the skills and know-how of various scientific, university, public and private partners in developing and developed countries to develop new effective, affordable and simple to use medicines. This success of the AS/MQ project was made possible thanks to the participation of: Far Manguinhos, ( Brazil ); the WHO/ TDR programme, University Sains in Malaysia, the University of Oxford and Mahidol University, Thailand. www.dndi.org
DNDI is a not-for-profit drug development organization created in 2003 to improve the health and quality of life of people suffering from neglected diseases: DNDI aims to develop 6 to 8 new drugs by 2014 for human African trypanosomiasis, leishmaniasis, Chagas disease and malaria. It will raise awareness of the urgent need to develop drugs for these diseases and strengthen existing capacity in disease endemic countries.