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Panthera’s clinical trial sites in Preston, North Manchester and North London began dosing volunteers in the Phase III PROVENT trial which will evaluate AstraZeneca’s long-acting antibody combination, AZD7442, for the potential prevention of COVID-19.
The double-blind, placebo-controlled trial will include adult volunteers who have no history of COVID-19 and have an increased risk of infection, including those over 60, a BMI of over 30, a chronic medical condition, taking immunosuppressive medications or those more likely to be exposed, such as NHS workers, or those living in shared accommodation, such as students or the armed services.
Panthera’s dedicated research sites were selected to take part in the trial because of their experience in enrolling and supporting volunteers. The three sites have put in place strict protocols in place to minimise the risk to both volunteers and staff. This enables the company to continue running clinical trials throughout the pandemic.
The trial of AZD7442 single dose inoculation will run for a year and looks to recruit 5000 volunteers globally. The aim of the trial is to evaluate the safety and effectiveness of a combination of two long-acting monoclonal antibodies – man-made versions of naturally occurring human antibodies of the immune system – in preventing COVID-19 infection. The “antibody combination” differs from a vaccine as it provides antibodies, rather than prompting the body’s immune system to make them. The treatment is aimed at helping those people with a compromised immune system, who cannot be vaccinated, vaccine hesitant and those who are unlikely to respond to a vaccination.
In the event of any volunteers developing COVID -19 symptoms Panthera will be providing support to the patient and ensuring the study can continue with those individuals safely isolated.
Stuart Young CEO of Panthera commented: “We are delighted that we have been chosen to enroll volunteers in this critical study. We have taken great care in making sure our sites are as safe as possible for both volunteers and staff so that clinical trials can continue. This is vital in ensuring that there are new medications available to prevent and treat, not only COVID-19, but the many other conditions which afflict so many people.”
AstraZeneca’s LAAB combination, AZD7442, has been engineered with AstraZeneca’s proprietary half-life extension technology to increase the durability of the therapy for six to 12 months following a single administration. The inoculation combines two LAABs which are designed to increase the potency and reduce the risk of resistance being developed by the SARS-CoV-2 virus.
About Panthera Biopartners – an Independent Site Management Organisation Panthera Biopartners was founded by Dr Ian Smith – founder of Synexus – and Professor John Lyon – previously senior executive in Covance and serial entrepreneur – to provide CROs and pharma clients with services relating to the recruitment and running of clinical trials at customised clinical trial sites by GCP trained healthcare professionals.
Panthera has a growing network of sites across the UK managing studies in a variety of conditions in both primary care settings and hospital sites running trials in key secondary care conditions such as CNS, oncology and NASH with specialist investigators.