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A South African pharmaceutical company has developed a candidate treatment for the Ebola virus and is preparing to begin a clinical trial in parts of Africa affected by recurring outbreaks.Xylomed Pharmaceuticals is planning a double-blind, randomised clinical trial of its experimental Ebola therapeutic in the Democratic Republic of the Congo (DRC), Uganda and South Sudan. The company hopes the trial 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 Mauritius-headquartered Xylomed Pharmaceuticals, said the company’s research identified a medicine that prevents the Ebola virus from replicating.“The pharmacological mechanism of action of our medication has shown great promise in stopping the virus from replicating itself in human beings,” Palane told the Sunday Times.He said 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,” Palane said.He explained that the molecule’s structure is already well defined and that its safety profile has previously been established.“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,” he said.According to Palane, the upcoming trial will 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,” he said.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.— Mkhululi Palane, group CEO of Xylomed PharmaceuticalsThe clinical trial has an estimated budget of €35m (R655m), covering the supply of medication, laboratory work and other operational costs.“It is a very complicated clinical trial, which is why it is proving to be a costly exercise,” he said.Palane said African pharmaceutical companies often struggle to compete because of limited access to funding.He added that the company’s treatment is an oral medication and, if proven 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,” he said.Beyond Ebola, Xylomed Pharmaceuticals is also developing treatments for cancer and SARS-related viruses and says it has more than 2,000 registered medicines.“Our passion comes from the fact that we are an African company,” Palane said. “We are committed to finding African solutions to the diseases that disproportionately affect the African continent.”He said the company chose to focus on Ebola despite the relatively small number of patients affected during outbreaks.“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,” he said.Recent Ebola outbreaks have affected communities in the DRC, Uganda and South Sudan, prompting authorities to tighten movement controls in affected areas.Palane described Ebola as one of several “orphan diseases” that attract limited commercial investment because they primarily affect low- and middle-income countries.“Diseases such as Ebola and dengue fever have historically attracted far less commercial interest because they do not significantly affect developed economies,” he said.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,” he said.Palane added that, on average, only one out of every 100 molecules investigated during pharmaceutical research ultimately reaches the market.Palane said it was a very small success rate, despite the significant investment required across many potential molecules.
