Report on the ATTRACT study

Vicore CMO Rohit Batta has been making progress with our ATTRACT study, which will investigate a potential treatment for COVID-19.  Here’s Rohit’s report on what’s been happening:

There’s an element of serendipity in how this study came about.

As the details of how COVID-19 acts on the body became known, we were able to join the dots, based on our specialist in-house knowledge and expertise.  We are a company that focusses on the development of treatments for rare lung conditions; COVID-19 certainly isn’t rare but we identified a segue into this space, given the hyperactive immune state that patients suffer resulting in pneumonia, respiratory failure and death.  We realised that this mode of disease has several correlations to our work in Idiopathic Pulmonary Fibrosis (IPF)

Because there is a clear unmet need, and this is a disease with a massive human burden, we felt that we had a duty to engage and started to develop ATTRACT: Angiotensin II Type Two Receptor Agonist in COVID-19 Trial

We have a nimble clinical development team here at Vicore and can make decisions and act far quicker than many other, larger companies. We managed to obtain MHRA approval for the study, and then ethics approval all within the space of 4 weeks. Our Head of Clinical Operations Mimi Flensburg has been leading these efforts, keeping a constant theme of patient centredness within our virtual working model.

There is strength in numbers and our boutique contract research organisation Orphan Reach has been doing a lot of the heavy lifting. The MHRA and EC have been incredibly engaging with a close dialogue facilitated by virtual meetings. There have been CMC challenges to address too, and our innovative colleagues at Ardena have been a vital part of this process, working hard to develop a novel solid, capsule formulation (all we had to work with in previous trials was a frozen, aqueous solution) and helping prepare for this important trial.

Collaboration was clearly vital to the speed and quality of the setup of this study.  We are very lucky to be able to work with Professor Jo Porter at UCLH, who has worked tirelessly to help setup the trial.

 

During a pandemic, real objective data is hard to obtain (there are many, many opinions but finding solid data can be challenging!).  Jo Porter has been great by helping to guide the study design, in particular with direction on study endpoints, which consider clinical aspects of heterogeneity.

The ATTRACT study will investigate the extent to which our hypothesis of using VP01 to rebalance the RAS (renin angiotensin system) can help to mitigate the COVID-19-mediated immune system overreaction that can lead to severe morbidity and mortality.  Full details are shown in our infographic below:

 

We have high hopes that our hypothesis can be proven with evidence from this proof of concept study leading to development of a therapy for COVID-19

In late March, LifeArc launched a £10 million fund to support research and testing of therapeutics that could be rapidly deployed to help address COVID-19’.  LifeArc is a self-funding charity with a mission to drive medical innovation through its own research and its work with a range of partners from industry, charities, universities, research organisations and others involved in improving lives for patients.

We applied for this programme, and it was announced on 1 June that the ATTRACT study had secured part of the funding, to allow us to expedite the trial.  We are delighted to receive this external validation of the importance of ATTRACT in the search for a potential treatment for COVID-19.

Now, we are actively screening patients and have the aim to delivery top-line results in the later part of the year.  We are immensely proud to be part of the global pharmaceutical team working to find treatments for COVID-19.

 

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