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July / August 2020 • PharmaTimes Magazine • 12

// RESEARCH  //


Research charities warn of corona funding cuts

UK charities including Cancer Research UK (CR UK) and the British Heart Foundation are warning that research funding will take a substantial hit in the wake of COVID-19, and that this will likely have significant consequences on patient survival.

CR UK said it could be forced to cut as much £150 million per year from its research funding “as the COVID-19 pandemic decimates its income”, which could “set back the progress we have seen in survival for people with cancer”.

Back in April the charity announced a cut of £44 million in funding across its research portfolio because of the pandemic, but is now preparing for a 30% fall in income in the 2020/21 financial year, with further losses in the next year, following temporary closures of its shops and major fundraising events being cancelled during the COVID-19 crisis.

Cutting £150 million each year would mean: a major contraction in the charity’s research infrastructure with potential closure of sites around the country; thousands of early-career scientists left unsupported, and their ideas for beating cancer unfunded; and cancelling plans to fund new projects in the short term, including new clinical trials, holding back the development of new cancer treatments, it said.

The BHF warned that the impact of the pandemic means that its net income, and resulting investment in new research, is likely to drop by up to 50% this year, from £100 million to around £50 million.

Such a sharp fall “could have a catastrophic impact on UK cardiovascular research, the research careers of thousands of young scientists, and advances in diagnostics, treatments and cures for people with heart and circulatory diseases”, it said.

The charity funds over half of non-commercial research into heart and circulatory diseases in the UK, but the loss of income from shop closures and cancellation of fundraising events “has created the biggest crisis in its 60-year history”. Furthermore, it could take several years for funding to return to pre-pandemic levels, it warned.

Chief executives from the Association of Medical Research Charities (AMRC), including CR UK, the BHF and Parkinson’s UK, are now calling on the government to introduce a Life Sciences Partnership Fund and match charity funded research for the next three years.

Medical research charities accounted for £1.9 billion (51%) of non-commercial research funding in the UK last year, but the AMRC is projecting a £310 million shortfall in this spend over the next year and expect it to take nearly five years for funding to return to previous levels.


The Lancet retracts hydroxychloroquine deaths study

The Lancet has issued a statement that a study which linked hydroxychloroquine to higher rates of death in COVID-19 patients has been retracted, after three of its authors said they were unable to ‘vouch for the veracity of the primary data sources’.

The registry analysis, which was published in The Lancet on May 22, looked at data from around 15,000 people who had been treated with hydroxychloroquine or chloroquine, and found a higher death rate in those with COVID-19, which caused the WHO to place a hold on trials assessing the drug’s potential to treat patients with the virus.

US healthcare analytics group Surgisphere and its founder Sapan Desai – the fourth co-author of the paper – carried out the initial analysis of data. However, after publication “several concerns were raised with respect to the veracity of the data and analysis” conducted by Surgisphere and Desai, the three other co-authors of the study, Mandeep R Mehra, Frank Ruschitzka and Amit N Patel, said in a statement.

“We launched an independent third party peer review of Surgisphere with the consent of Sapan Desai to evaluate the origination of the database elements, to confirm the completeness of the database and to replicate the analyses presented in the paper,” they added.

“Our independent peer reviewers informed us that Surgisphere would not transfer the full data set, client contracts and the full ISO audit report to their servers for analysis as such transfer would violate client agreements and confidentiality requirements. As such, our reviewers were not able to conduct an independent and private peer review and therefore notified us of their withdrawal from the peer-review process.” The authors therefore requested that the paper be retracted.

In a statement, The Lancet said it takes issues of scientific integrity “extremely seriously”, and noted that there are “many outstanding questions about Surgisphere and the data that were allegedly included in this study”.


NIHR/MRC fund new study on ME

The National Institute for Health Research (NIHR) and the Medical Research Council (MRC) are funding a new UK study that aims to investigate whether there are any genetic anomalies related to the development of myalgic encephalomyelitis (ME).

The DecodeME study will analyse samples from 20,000 people with ME to search for genetic differences that may indicate underlying causes or increase the risk of developing the condition, in the hope of aiding development of diagnostic tests and targeted treatments.

ME, also diagnosed as chronic fatigue syndrome (CFS), affects an estimated 250,000 people in the UK. People experience debilitating symptoms associated with post-exertional malaise, the body and brain’s inability to recover after expending even small amounts of energy.

Despite its high cost to patients, the economy, the NHS and society, very little is known about the causes of the condition and how to treat it effectively. Previous research has shown that a greater risk of ME/CFS may, in part, be inherited, the NIHR noted.

“Our focus will be on DNA differences that increase a person’s risk of becoming ill with ME/CFS,” said Professor Chris Ponting, from the MRC Human Genetics Unit at the University of Edinburgh, who is leading the study. “It is our hope that this study, the world’s largest genetic analysis so far, will transform ME/CFS research by injecting much-needed robust evidence into the field.

“Unlocking the genetic susceptibility to ME/CFS is a key part of understanding what causes ME/CFS and the disease mechanisms involved.”

This, in conjunction with other biomedical research into ME/CFS, should finally pave the way to better diagnosis and the development of specific treatments for this debilitating disease,” added Dr Luis Nacul, who co-leads of the study and runs the [HJ-U6] CureME Biobank, from the London School of Hygiene and Tropical Medicine.

‘DecodeME’ is being led by the ME/CFS Biomedical Partnership, with researchers from the MRC Human Genetics Unit at the University of Edinburgh and the London School of Hygiene and Tropical Medicine. The study is scheduled to begin in September, with recruitment of participants from March 2021.


MHRA green light for Redhill’s COVID-19 trial

The UK Medicines & Healthcare products Regulatory Agency (MHRA) has approved RedHill Biopharma’s application to carry out a Phase II/III study evaluating Yeliva (opaganib) in patients hospitalised with severe SARS-CoV-2 infection and pneumonia.

Opaganib, a new chemical entity, is a first-in-class, orally administered, sphingosine kinase-2 (SK2) selective inhibitor with anticancer, anti-inflammatory and antiviral activities.

The multicentre, randomised, double-blind, parallel-arm, placebo-controlled Phase II/III study is set to enrol up to 270 subjects with severe COVID-19 pneumonia requiring hospitalisation and treatment with supplemental oxygen.

The primary endpoint of the study is to evaluate the proportion of patients requiring intubation and mechanical ventilation by Day 14.