NovaBiotics clinical testing of COVID-19 drug | ONE

NovaBiotics’ Nylexa® therapy has a unique dual-action. It targets the infection and hyper inflammation that are the causes of morbidity and mortality in COVID-19. Nylexa also acts against bacterial lung infections that, in some cases, can occur in COVID-19 patients, secondary to SARS-CoV-2 infection and which lead to much worse outcomes.

The active ingredient of Nylexa is readily available, cost-effective and scalable, offering the potential for near-term, large-scale use by healthcare systems, subject to the successful completion of clinical development. This ingredient and related compounds have been in use in medicines that treat unrelated conditions for over 30 years.

Nylexa can proceed directly into phase 2 clinical studies and is under consideration for inclusion in two, critically important, global platform trials. As a repurposed therapy which addresses a public health emergency, Nylexa is likely to continue to follow a fast-track pathway to completion of its clinical development and regulatory approval for licensing as a medicine in the UK and globally.

The grant from Innovate UK will support NovaBiotics in completing the manufacturing of the clinical trial material and preparation work for phase 2 clinical testing in hospitalised COVID-19 patients with moderate to severe disease.

Dr Deborah O’Neil, CEO of NovaBiotics, commented: "There are currently no products in use or development for COVID-19 with the established safety profile and unique dual antimicrobial-immunomodulatory activity of Nylexa. Available treatment options are generally single-target therapies that address only the SARS-CoV-2 virus or the hyper inflammation associated with it. Nylexa, in contrast, targets multiple drivers of COVID-19 pathology and therefore offers a much greater chance of clinical success.

“Even if a vaccine becomes available, which we all hope will be the case, it will not be 100% effective or available for the entire population at the scale required for global coverage for some time, if ever. Nylexa could de-risk the consequences of contracting SARS-CoV-2, facilitate a faster return to employment/education and mitigate its long-term health impacts of COVID-19.

“UK Research and Innovation has awarded us this grant against stiff competition, recognising the potential of Nylexa. We’re delighted that this supports us in moving towards phase 2 clinical testing in COVID-19 and ultimately confirmatory clinical studies and look forward to beginning work on this programme as soon as possible.”

Dr Ian Campbell, Executive Chair of Innovate UK, added: “By tackling infection and inflammation at the same time, two of the primary causes of morbidity and mortality in COVID-19, Nylexa potentially offers not only greater chance of clinical success but the potential to help people return to their daily lives - ultimately reducing the burden on public health and supporting broader economic recovery.

“We’re delighted to be able to provide the support for NovaBiotics to develop this promising programme further and look forward to following the progress of studies closely.”

NovaBiotics Ltd is a clinical-stage biotechnology company focused on the design and development of first-in-class therapies for difficult-to-treat, medically unmet infectious diseases caused by bacteria and fungi and respiratory conditions including cystic fibrosis and COVID-19. A leading innovator in the anti-infectives space, the company's robust technology and business model have been validated through successful development, from concept to late-stage clinical development, of its most advanced product candidates.