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Coronavirus Update: Oxford Racing Ahead With 8,000 Vaccinated In Phase III Trial

Coronavirus Update: Oxford Racing Ahead With 8,000 Vaccinated In Phase III Trial

Source : 'Scrip Intelligence'

The University of Oxford team developing a coronavirus vaccine with AstraZeneca is well ahead in the race to conduct late-stage trials, with 8,000 volunteers already dosed in its Phase III study.

This puts it far in advance of other frontrunners such as Moderna and Pfizer, who are yet to begin their Phase III trials.

The candidate, known as AZD1222, was identified last week as the clear frontrunner in terms of its progress through clinical studies by the World Health Organization (WHO), and the trial’s lead investigator has now shared details of its rapid development.

Professor Sarah Gilbert is professor of vaccinology at Oxford Jenner Institute, and co-developer of the adenovirus-based vaccine. She gave evidence to the UK parliamentary House of Commons Science and Technology committee on 1 July, alongside other leaders in the country’s life science sector spearheading COVID-19 vaccines and therapeutics development.

Professor Gilbert said: “We now have 8,000 people vaccinated in the phase three trial in the UK, that's very good going. Apart from the ability to test efficacy...that also gives us the safety database that we need, because we're looking at the vaccine in older adults as well as younger adults. We need safety data and we need to look at the immune response in people of different ages as well.”

The declining prevalence of COVID-19 in the UK has meant the researchers have widened their net to other countries where the infection rates are still high. The Oxford team has signed agreements with researchers in South Africa and Brazil, and has already dosed several hundred volunteers in Brazil.

Professor Gilbert said this would soon rise to 4,000 in Brazil and a further 2,000 in South Africa, with AstraZeneca commencing a study of up to 30,000 people in the US in August.

Nevertheless, there are still many unknowns regarding AZD1222, not least the Phase I/II data already generated, which the Oxford team has still not published, even though most of their competitors have presented topline data or published in full in peer-reviewed journals.

Eisai's eritoran, which failed as a treatment for sepsis almost a decade ago, has been selected as the first investigational immune modulation therapy to be included in the subset of the large platform REMAP-COVID study designed to assess various treatments for COVID-19.

The Japanese drugmaker has teamed up with the Global Coalition for Adaptive Research and the University of Pittsburgh Medical Center to test eritoran, a TLR-4 antagonist, alone and in combination with other drugs to evaluate its effectiveness in COVID-19 hospitalized patients. The drug is designed to suppress the over-production and release of various pro-inflammatory mediators, ie cytokine storm, and Eisai hopes to prove that eritoran can protect against damage in COVID-19 patients’ lungs and other organs.

REMAP-CAP (randomised, embedded, multi-factorial, adaptive platform trial for community-acquired pneumonia), was originally designed to find optimal treatments for severe pneumonia both in non-pandemic and pandemic settings. When COVID-19 began, it rapidly pivoted to pandemic mode and the adaptive design of the REMAP-COVID substudy means it has a number of arms, including antibiotics, hydrocortisones and now immune-modulatory drugs.

Eritoran was previously observed to be safe in a large Phase III trial for sepsis but the study was terminated in 2011 after the drug failed to prove effective. The compound showed potential as a flu treatment in studies back in 2013 but the asset has not been a priority for Eisai of late. SC084330

By Scrip Team