Research by a South African pharmaceutical company has identified a drug that prevents the Ebola virus from replicating, with a team now planning a clinical trial in the Democratic Republic of Congo, Uganda and South Sudan, reports TimesLIVE.
This comes as the University of Oxford has launched the first human trial of a vaccine against Bundibugyo Ebola virus in efforts to help fight the outbreak spreading. More than 700 deaths have been recorded so far.
Xylomed Pharmaceuticals hopes the double-blind, randomised clinical trial of its experimental therapeutic will determine whether the medicine is effective in treating the highly infectious virus, which has recorded fatality rates of up to 70% in some outbreaks.
Mkhululi Palane, group CEO of the Mauritius-headquartered company, which has a strong operational base in Pretoria, said its medication had shown great promise in stopping the virus from replicating itself in human beings.
The company’s research and development programme had resulted in what he described as a “simple chemical molecule” with the potential to treat Ebola, including in patients with advanced stages of the disease.
“The phase 3B clinical trial will allow us to determine the efficacy of this particular molecule,” he told the Sunday Times.
The molecule’s structure is already well defined and its safety profile has previously been established, he added.
“We know it is safe. It is a molecule that is already useful in medicine, and we are repurposing it as a potential treatment for Ebola.”
Palane said the upcoming trial would be the final major stage of testing before regulatory consideration.
“We will be able to determine very quickly whether it is effective in saving lives.”
The company is finalising partnerships with universities in South Africa, Botswana and Europe, as well as a clinical management company, to conduct the study and recruit participants in the DRC, Uganda and South Sudan.
“We are putting together a consortium to ensure we are able to recruit patients and conduct the trial effectively,” Palane said.
Ebola outbreaks typically affect around 10 000 people at a time. The cost per patient is very high, which is why many large pharmaceutical companies avoid investing in it.
The clinical trial has an estimated budget of €35m, covering the supply of medication, laboratory work and other operational costs.
“It is a very complicated trial, which is why it is proving to be a costly exercise,” he added.
The treatment is an oral medication and, if effective, could be suitable for children as young as two years old.
“This could reduce the burden on hospitals because patients may even be treated at home,” Palane said.
Beyond Ebola, Xylomed Pharmaceuticals is also developing treatments for cancer and SARS-related viruses: it already has more than 2 000 registered medicines.
He described Ebola as one of several “orphan diseases” that attract limited commercial investment because they primarily affect low- and middle-income countries.
“Diseases like Ebola and dengue fever have historically attracted far less commercial interest because they do not significantly affect developed economies,” he pointed out.
He said the cost of developing a new medicine can reach as much as $300m once toxicology studies, clinical trials and regulatory approval processes are taken into account.
“The cost of conducting clinical trials is extremely high. It involves recruiting patients, establishing multiple trial sites across different populations and meeting stringent regulatory requirements.”
On average, only one out of every 100 molecules investigated during pharmaceutical research ultimately reaches the market.
Meanwhile, CNBC reports that the early-stage Oxford trial, known as BD-Ebov, will evaluate the safety and immune response of the ChAdOx1 BDBV vaccine in 50 healthy adults aged 18 to 55 in Oxford, the university said on Monday, adding that recruitment has already begun, with vaccinations expected to start in the coming weeks, pending regulatory approval.
The jab was developed by scientists at Oxford’s Vaccine Group and Pandemic Sciences Institute using the same viral vector platform as the Oxford/AstraZeneca Covid-19 shot.
Serum Institute of India, which is partnering on the programme, said it had manufactured and stockpiled about 620 000 doses of the vaccine candidate within two weeks and supplied 4 000 investigational doses for the early-stage study.
In May, the WHO had recommended prioritising the ChAdOx1 BDBV vaccine, alongside a single-dose candidate known as rVSV Bundibugyo, being developed by the International Aids Vaccine Initiative, for clinical evaluation as part of the response to the outbreak.
The Coalition for Epidemic Preparedness Innovations (CEPI) has said it would initially invest up to $8.6m for the development of the shot.
Preparations are also under way for additional clinical studies in Uganda, subject to regulatory approval, through partnerships including the Medical Research Council/Uganda Virus Research Institute and the London School of Hygiene and Tropical Medicine Uganda Research Unit.
If the early-stage trial is successful, CEPI said it would work with Oxford and Serum Institute to support late-stage studies needed to seek emergency-use authorisation or full regulatory approval.
The partners said they aim to ensure rapid and affordable vaccine supplies for affected countries.
But as the deadly virus spreads into another two DRC provinces, staff treating patients at a large hospital have gone on strike over late payments, saying they have not been paid for months, reports Al Jazeera.
Dozens of employees at Rwampara General Hospital in Ituri province, the epicentre of the outbreak, walked off the job on Monday.
They include epidemiologists, case investigators, drivers and gravediggers, with one telling The Associated Press: “We don’t know how it is possible to not have been paid for two months.”
DRC Health Minister Roger Kamba said last week that the government was working to resolve the payroll issues and ensure employees were paid.
“We must ensure these payments reach the right people,” he added. “We have faced a few challenges, notably changes to the lists, which have led to complaints from people saying they are not being paid even though they are working. We have the means to sort this out.”
The outbreak has already pushed nearly 1m people into poverty, according to the United Nations, with efforts to contain it having been complicated by the presence of paramilitary rebels, who control parts of the region in a bid to access its valuable mineral deposits.
The response to the outbreak has also been complicated by misinformation, deeply rooted burial practices and a lack of trust in health officials.
Health workers have been attacked by communities that believe the disease is a form of witchcraft, while bereaved families have ignored safety protocols by holding traditional burial ceremonies.
The WHO has warned that an accelerated response from local, national and international partners is urgently needed to bring the outbreak under control.
According to the latest figures, 1 926 cases have been recorded and 702 deaths, with five provinces now having been affected.
The International Rescue Committee (IRC) has warned that the situation is worsening in areas already affected as transmission accelerates, while the risk of the disease spreading to neighbouring South Sudan is increasing as the outbreak expands into new areas.
Staff at DRAl-Jazeera – Congo Ebola centre strike as virus continues spreading
CNBC – Oxford begins first human trial of Bundibugyo Ebola vaccine
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