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13th April 2020 - NovaBiotics announces fast-track repurposing of its experimental drug Nylexa for COVID-19 trials and plans for earliest possible compassionate use

NovaBiotics, the clinical stage antimicrobials drug discovery company, announces the rapid repurposing of Nylexa for the ‘hidden killer’ underlying COVID-19: secondary bacterial lung infections.  Nylexa ‘supercharges’ antibiotics, boosting their efficacy against difficult to treat and even drug resistant bacteria.  The active ingredient of Nylexa is already in advanced clinical trials.  It has proven to be safe and effective in clinical studies carried out across the UK, Italy and the US for the complex bacterial lung infections associated with cystic fibrosis (CF).  Nylexa could be rapidly re-positioned as a COVID-19 therapy and tested in patients in the second half of 2020, ahead of any vaccine being available.

Bacterial co-infections with SARS-CoV-2 (the virus that causes COVID-19) have now been shown to result in worse outcomes for COVID-19 patients.  More than 50% of the COVID-19 patients who died in Hubei province, China, succumbed to a bacterial infection/sepsis, despite having been given antibiotic therapy.  This trend is continuing across other global regions and, as we learn more about this disease, it seems poorer COVID-19 outcomes are linked to regions where there is a higher background of antibiotic usage and therefore antibiotic resistance.

The body’s immune response to respiratory viral infections (influenza, coronavirus etc.) increases susceptibility to secondary bacterial infections and this risk is even greater with SARS-CoV-2.  Many of the bacterial lung infections in COVID-19 patients do not, however, respond to antibiotic therapy.  This is due to the fluid and mucus within the lungs making it harder for the antibiotic to reach the bacteria and, more worryingly, the fact that the bacteria are resistant to the antibiotic drug being used.  Nylexa addresses both of these causes of antibiotic therapy failure.  By boosting the effects of antibiotics given to COVID-19 patients who have, or are suspected to have, secondary bacterial infections, Nylexa could have significant benefit, improving survival rates first and foremost, but also aiding recovery mid to longer term with less fibrotic lung damage.  NovaBiotics has already demonstrated that the active component within Nylexa reduces inflammation and is highly effective in breaking down mucus in the airways of infected CF patients.

NovaBiotics could begin manufacturing of Nylexa for trials in May.  In partnership with the NHS and subject to MHRA and ethics committee approvals, clinical studies could get underway in a very short space of time in patients hospitalised with COVID-19.  The company anticipates that subject to positive trial results, the use of Nylexa will continue on a named patient /compassionate use basis during the outbreak beyond the trial in the UK and other countries.

Deborah O’Neil, CEO of NovaBiotics commented: “The impact of bacterial infections and antibiotic resistance in COVID-19 is beyond doubt.  Our strategy to expedite Nylexa’s development to address this aligns 100% with the UK Government’s ‘wave 2 COVID-19 clinical trials’ strategy to test repurposed experimental therapies already in late stage clinical trials for other indications.  Whilst ‘wave 1’ focused on the potential benefit of repurposed, already licensed antiviral and antimalarial therapies, and whilst vaccine development continues for the longer term, it is critical to develop rapidly deployable strategies to prevent deaths and long term health issues from secondary bacterial infections caused by SARS-CoV-2.  These infections could still be fatal regardless of antiviral or other experimental treatment.  Nylexa is low risk, low cost, readily available candidate treatment that could be tested and deployed to combat the coronavirus pandemic very quickly”.

Professor Dilip Nathwani OBE, Consultant physician and Emeritus Honorary Professor of Infection, University of Dundee, said: “Secondary bacterial infections have been long recognised as an important and devastating cause of mortality in patients with primary viral pneumonia.  In my 30 years of clinical practice, despite the administration of timely and appropriate antibiotic therapy to cover against these secondary bacterial infections, I have seen a significant number of patients tragically still succumb to the infection.  This is supported from data emerging during the COVID-19 crisis.  Therefore, during this current pandemic of COVID-19 respiratory infections, the need to consider and test antibiotics that offer alternative and complimentary modes of action are worthwhile and of critical importance. I believe Nylexa may be such a potential treatment requiring urgent assessment of its efficacy.  Its evaluation needs to be now.”



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