News
The
European and Developing Countries Clinical Trials Partnership (EDCTP)
(www.EDCTP.org) grants €10 million over five years to “WANECAM 2” a unique
collaboration between antimalarial drug researchers in Africa and Europe from
ten academic institutions, a pharmaceutical company, Novartis, and a
not-for-profit product development partnership (PDP), Medicines for Malaria
Venture; the grant will support African trials of a novel antimalarial
combination comprising KAF156 (ganaplacide) and lumefantrine in a new
once-daily formulation. KAF156 has demonstrated the potential to treat
resistant malaria and to be administered as a single dose; the grant will also
help to build and strengthen research capabilities in the four participating
African countries: Burkina Faso, Gabon, Mali and Niger.
The
European & Developing Countries Clinical Trials Partnership (EDCTP) has
granted new funding of €10m over five years to support late-stage clinical
trials of a next-generation antimalarial combination including KAF156
(ganaplacide). The trials will be conducted in four countries in West and
Central Africa: Burkina Faso, Gabon, Mali and Niger.
Led
by the WANECAM consortium (West African Network for Clinical Trials of
Antimalarial Drugs), ten academic organisations [1] based in Africa and Europe
will collaborate with the not-for-profit organization Medicines for Malaria
Venture (MMV) and the pharmaceutical company Novartis to develop its compound
KAF156 in combination with a new formulation of lumefantrine. The aim is to
advance the development of a much-needed new antimalarial therapy while
strengthening clinical trial development capabilities in Africa.
Global
partnerships have made significant strides in malaria control over the past 20
years, yet the rate of progress has recently diminished [2]. A recent survey of
African malaria leader [3] showed high levels of concern around resistance to
some of the current gold-standard treatments, artemisinin combination therapies
(ACTs), in Asia, and the likelihood that it could spread to Africa, emphasizing
the urgent need for novel, easy-to-administer antimalarial medicines.
The
Principal Investigator, Professor Abdoulaye Djimdé of the L'Université des
Sciences, des Techniques et des Technologies de Bamako and coordinator of the
WANECAM group, said: “We welcome the generous support from EDCTP and are
grateful for their long-term commitment to clinical development in Africa – and
specifically supporting clinical research in critical diseases such as malaria.
This backing is vital to accelerate the development of this much-needed new
compound. African collaboration with a group of international experts on this
programme can help ensure the trials are completed rapidly and to the highest
quality standards. With reports about parasite resistance to artemisinins and
ACTs, it is essential that we have new antimalarials ready and waiting.”
KAF156
[4], the new antimalarial compound that will be studied, holds the potential to
be the first new chemical class of compound for the treatment of acute malaria
in 20 years which in combination with the new formulation of lumefantrine could
be administered as a single-dose treatment.
The combination is currently in late-stage clinical trials across 17
centres in nine countries in Africa and Asia. It is being developed by Novartis
with scientific and financial support from MMV (in collaboration with the Bill
& Melinda Gates Foundation), and is one of seven late-stage antimalarials
being developed by MMV partnerships. The EDCTP grant will fund two clinical
trials for KAF156 in combination with a new formulation of lumefantrine which
will include studying its effectiveness in children, the group most at risk of
dying from malaria. If successful, data from these trials will support future
submissions to register the medicine with regulatory authorities.
The
EDCTP funding will also support efforts to strengthen clinical research
infrastructure in Niger, as well as existing clinical research capacities at
all other trial sites involved. These efforts will involve exchanging
experiences and best practices between the sites and the European academic
centres, as well as with Novartis and MMV.
Dr.
Michael Makanga, EDCTP Executive Director, said: “We are delighted to broaden
the coalition of organisations that EDCTP funds and partners to deliver our
malaria strategy. By involving the private sector and a not-for-profit PDP, we
have broadened our network of expertise. With all sectors working together, we
can build stronger partnerships to defeat malaria.”
By
2017, malaria mortality had more than halved in sub-Saharan Africa compared to
the turn of the century, due to better prevention, mainly via bednets, and
improved treatment with ACTs. However, over 400,000 people died due to malaria-related
causes that year, most of them young children under the age of five. The most
recent 2018 World Malaria Report stated that progress in the fight against the
disease is flattening for the second year in a row.
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