A message from MMV's CEO, David Reddy
Dear colleagues and friends,
The last nine months have been unlike any we have experienced in our lifetime. The COVID-19 pandemic has had a profound impact on all of us and I extend my sympathies to those among you who have lost loved ones to the pandemic as well as those who have experienced serious challenges in the past year.
As the virus continues to disrupt the economic, political, social and health systems of the world, the value of scientific research and of international partnerships is abundantly clear. On a positive note, the pandemic propelled us to rapidly hone our ability to work in partnerships with clear focus and agility.
MMV is proud to have played its part in responding to new challenges to malaria control brought about by COVID-19, and in supporting the pandemic response itself. Early on we adapted our work plan for anticipated pandemic-related delays, while accelerating other areas of work to ensure that we could emerge with the strongest possible malaria portfolio. In parallel, we also reprioritized our areas of strategic focus for 2020 to include support for the COVID-19 effort.
Beyond the new COVID-19 pivot, our priority, as always, remains our malaria patients and our core work – the discovery, development and delivery of new, effective and affordable therapies for the treatment and prevention of malaria. Since 2009, with our partners, we have brought forward 13 new malaria therapies estimated to have saved the lives of over 2.2 million people. This work continues as we focus on expanding access to treatment with approved medicines; are addressing unmet therapeutic needs of children and pregnant women; and tackling resistance with new tools.
The recently launched special edition of the World Malaria Report 2020 projects that due to COVID-19 WHO’s interim targets set for 2020 for the reduction of case incidence and mortality will be missed by 37% and 22%, respectively. If we are to meet the WHO’s 2030 goal of reducing malaria incidence and mortality by 90%, increased commitment is imperative and MMV remains more committed than ever to playing its part.
As this extraordinary year draws to a close, I would like to thank you for your unstinting support over the years. It is deeply appreciated. None of our progress this year would have been possible without you, our partners, old and new. And most of all, none of this would have been possible without the commendable resilience and flexibility of the MMV team, whose support to the organization in these unprecedented times has been more than stellar. Some of us have had COVID-19, some of us haven’t seen our families in months, and yet we have supported each other through this crisis.
We will continue to share all the expertise and experience we possess to help reduce the threat of SARS-CoV-2, and above all will pursue our vision of a malaria-free world, with renewed energy and a new perspective on the power and possibility of partnership. Lives depend on it.
Wishing you a restful end of year break and a peaceful 2021.
Stay safe and well.
Dr David Reddy, CEO, MMV
In support of COVID-19
Access to critical medicines, useful for both malaria and COVID-19: With the increase in global demand for antimalarial drugs as possible COVID-19 interventions, MMV has been working with WHO, partners and major suppliers to coordinate efforts to safeguard access to critical malaria commodities, e.g., diagnostics, nets, medicines etc.
Access to preventive therapies: MMV is also working with WHO and partners to safeguard the implementation of critical, life-saving campaigns, such as Seasonal Malaria Chemoprevention (SMC). We have provided guidance to countries on how to adapt these campaigns and use COVID-19 safety measures such as social distancing. We have also been closely monitoring the supply chain (manufacturing, shipment, and delivery) of SP+AQ (the therapy used for SMC) to ensure that the June-November campaign season stayed on target.
Assets and expertise to help lessen the impact of COVID-19: in March, we quickly assembled and sent a set of antimalarials and a diverse set of drugs and compounds with potential SARS-CoV-2 activity to testing centers in the USA and Europe. The team have also been providing modelling and simulation as well as screening data to support this work.
Compounds to stimulate research in coronaviruses: to spearhead new collaborative and open research for coronaviruses and other diseases of pandemic potential, MMV’s Pandemic Response Box sets, each with 200 antivirals, are being shipped to researchers – to date 122 copies are in the hands of researchers around the world. In addition, in July a new open access box was launched: the COVID Box of 160 compounds with known or predicted activity against SARS-CoV-2. So far, 49 copies have been distributed free-of-charge.
A new drug discovery programme to address infections by drug-resistant malaria parasites and coronaviruses: Up to 40 new compounds are being synthesized per month and then tested against SARS-CoV-2 infected cells in vitro to assess the possibility of delivering a candidate drug against coronaviruses.
Already approved medicines as options for COVID-19: MMV is partnering on clinical studies investigating options for a COVID-19 therapy and is a member of COVID-19 Clinical Research Coalition, which seeks to accelerate research on the prevention and treatment of COVID-19.
To single-dose tafenoquine
This year, a focus has been to advance access to tafenoquine (TQ), the single-dose medicine to prevent the relapse of P. vivax malaria that we co-developed with GSK. In April, Thailand became the first country in S.E. Asia to grant Marketing Authorization Approval for the treatment. Approval in Thailand is an important first step to opening access to TQ more broadly across Asia-Pacific where the P. vivax species is becoming the most dominant.
To protect children
To protect an estimated 22 million children in African’s Sahel region, eighty-five million seasonal malaria chemoprevention (SMC) treatments were administered in 2019 across 13 countries. However, around 13 million eligible children did not have access to SMC programmes and many did not receive the full number of monthly treatments needed to protect them through the high-risk rainy season.
- OPT-SMC: Recognizing the urgent need to close this gap and optimize the delivery and effectiveness of SMC, MMV, the London School of Hygiene and Tropical Medicine and partners launched the OPT-SMC project to strengthen capacity of national programmes to conduct implementation research and adapt SMC to the local context.
The COVID-19 pandemic was an additional complication to the deployment of these lifesaving interventions, bringing new challenges to malaria prevention. But the malaria season stops for no pandemic and while children are at risk our work with OPT-SMC will continue.
Addressing unmet therapeutic needs
Of pregnant women
This year we shone a stronger light on the unmet needs of pregnant women. Malaria disproportionately impacts the 23 million women and girls who become pregnant in malaria-endemic regions every year. MMV has maintained a strong focus on children and women of reproductive age, and this year further intensified that focus with the launch of the MiMBA strategy. MiMBa stands for Malaria in Mothers and Babies and means pregnancy in Swahili. The strategy aims to address the unmet needs of pregnant women and their babies. One of the key ways to do so is to generate more evidence on the impact of existing antimalarials on pregnant women, prioritize the development of new drugs deemed low risk to mother and foetus, and facilitate the inclusion of pregnant and breastfeeding women in clinical trials earlier than currently practiced. The strategy also aims to address the persistent low uptake of recommended intermittent preventive therapy (IPTp), sulfadoxine-pyrimethamine (SP), administered during routine antenatal care visits starting as early as possible in the second trimester of pregnancy. Key milestones in 2020 included:
- Pregnancy registry: As part of MiMBa, MMV and Liverpool School of Tropical Medicine established a registry in three malaria-endemic countries in Africa to gather much-needed safety and exposure data on use of antimalarials during pregnancy. It is anticipated that this will provide a robust framework from which policymakers can make informed policy decisions that will benefit pregnant women at particular risk of malaria.
- Call to action: As part of the RBM Partnership Malaria in Pregnancy Working Group, MMV and partner organizations renewed an urgent appeal to leaders and health policymakers across Africa: the ‘Speed Up Scale Up’ call to action. It called for improved protection of millions of pregnant women and their newborn children from the devastating consequences caused by malaria in pregnancy
Children remain the hardest hit by malaria and their unmet needs are top priority at MMV. Globally they are four times as likely as adults to be affected by relapsing P. vivax malaria and are especially vulnerable to mortality caused by cumulative severe anaemia from repeated P. vivax malaria episodes.
- Paediatric TQ: Data from the successful TEACH study that evaluated dosages of tafenoquine based on weight in children and adolescents between the age of 6 months and up to 15 years were presented at the American Society of Tropical Medicine and Hygiene online meeting in November. Ninety-five percent of the study’s 60 subjects had no recurrence of P. vivax malaria during four months of follow-up with a safety profile similar to previous clinical studies. With this milestone, we edged closer to making this medicine available to children, who are disproportionately affected by relapsing malaria.
Tackling resistance with new tools
As the malaria drug development community knows all too well, the Plasmodium parasite has repeatedly demonstrated its ability to evolve and become resistant to successive generations of antimalarial drugs, thus threatening the public health response to control the disease. Early indicators of artemisinin resistance, first reported in 2007 in S.E. Asia, were recently reported in Rwanda. While ACTs continue to cure malaria patients, this news is cause for concern and serves as an important reminder of the need to intensify surveillance for laboratory markers of antimalarial drug resistance and for any decline in the efficacy of malaria treatments in the field.
- Next generation medicines: The best insurance against the risk of antimalarial resistance is continued research into new medicines. MMV’s strategy to contain antimalarial resistance includes working with partners to develop and deliver high quality, WHO-prequalified, patient-friendly medicines, including paediatric formulations, that improve clinical effectiveness and adherence to treatment, thus reducing the probability of resistance. MMV has been successful at bringing new medicines forward, and its strategies to fight antimalarial resistance are relevant to the effort to contain all forms of antimicrobial resistance. Key milestones in 2020 included:
- The launch of the PAMAfrica research consortium led by MMV. The consortium of seven organisations from Africa and Europe with work on three clinical trials to support the development of medicines for populations most at risk including babies, severe malaria patients, and those with drug-resistant infections, while also strengthening research capacities at each site involved.
- In collaboration with Novartis, the initiation of Part B of the Phase IIB study trialling the most advanced non-artemisinin combination, ganaplacide and lumefantrine.
- Two novel compounds, MMV533 (formerly Sanofi SAR121) and MMV253 (Zydus Cadilla) underwent successful PK/PD evaluation in the human volunteer infection study model.
- ELQ331, a novel new chemical entity, was approved as a candidate following a positive review by MMV’s ESAC.
- Discovery networks and compound collections: Another important strategy is the development of discovery networks and assay platforms to accelerate identification of the most promising compounds against malaria as well as drug-resistant strains of other pathogens. We facilitate this with our compound collections that are given to researchers free of charge upon request. Our 2020 Project of the Year was awarded to Professor David Fidock and his team for their critical contribution to MMV’s drug resistance profiling, which is today supporting compound prioritization.
In addition to the Pandemic Response Box with 200 compounds, the COVID Box with 160 compounds, this year together with three renowned Indian research institutions we launched Malaria Libre, a new open source drug discovery programme where participants can freely share data and ideas to accelerate innovation.