Irish Consortium to Develop Novel Treatment for ARDS Caused by COVID19

An Irish consortium involving NUI Galway, OmniSpirant Limited, a start-up biotechnology company and Aerogen Limited, has been awarded €11.6 million under the Disruptive Technologies Innovation Fund (DTIF).

The funding will be used to develop a new exosome-based inhaled treatment for Acute Respiratory Distress Syndrome (ARDS) which is responsible for the vast majority of COVID-19 deaths. Research from the JAMA Internal Medicine suggests that more than 40% of individuals in the study hospitalised for severe and critical COVID-19 developed ARDS, and over 50% of those diagnosed died from the disease.

This cutting edge treatment also has the potential to treat Chronic Obstructive Pulmonary Disease (COPD). COPD is a disease that affects hundreds of millions of patients worldwide, it is the third leading cause of death globally and is currently lacking any effective treatments. The Global Burden of Disease Study reports a prevalence of 251 million cases of COPD globally in 2016. Globally, it is estimated that 3.17 million deaths were caused by the disease in 2015, 5% of all deaths globally in that year.

The three-year grant-funded programme aims to complete Phase 1 clinical trial studies in ARDS patients and to complete the preclinical development needed to support clinical studies in COPD patients.

Professor John Laffey, Professor of Intensive Care Medicine at NUI Galway and Consultant in Intensive Care Medicine, Galway University Hospitals, said: “Current pharmacologic therapies are of marginal benefit for COVID-19 patients suffering with ARDS, and advanced support of respiratory function in Intensive Care Units remains the main therapeutic approach. Aerosolized delivery of engineered cell products that can target the inflammatory response to COVID-19 could prevent or even reverse severe COVID-19 induced respiratory injury, which would be game-changing in reducing mortality from this devastating infection. It also shows very promising anti-infection benefits, which in addition to having knock-on benefits for COPD patients, could also be applied to other aggressive lung conditions such as Cystic Fibrosis patients.”

OmniSpirant will provide the technological expertise to produce exosomes from genetically modified stem cells. OmniSpirant has also developed a method to enhance the delivery of these exosomes into lung tissues. These exosomes will then be delivered by an inhaled aerosol to recode diseased lung cells in patients, using Aerogen’s expertise and best in class technology in this area. The Centre for Cell Manufacturing at NUI Galway will industrialise the scalable manufacturing process for this new treatment.

Gerry McCauley MPharm, MPSI, CEO OmniSpirant Limited, said: “We have entered the age of advanced therapeutics, where cell-based and gene therapies have the curative potential for complex diseases. Our proprietary technologies unlock the huge potential to effectively deliver novel treatments into the lung to address many serious lung diseases. Specifically, the DTIF funding is aimed at developing OS002, an innovative treatment which could address two major global pandemics. The death rate for ARDS shows that it has a mortality rate of 30-40% of those diagnosed with the disease. This currently lacks effective treatments and due to COVID-19 is causing a devastating global death toll. Even in a world without COVID-19 ARDS affects an estimated three million people every year. Secondly, OS002 could also prove transformational for chronic lung diseases, particularly the 100’s of millions of COPD patients globally who are currently suffering with no access to effective treatment options.”

Aerogen Ireland was founded in 1997 and are world leaders in the field of aerosol delivery devices. Drug delivery of cell therapies by aerosol of this nature has traditionally been complex and Aerogen are partnering on this new and novel treatment to provide the expertise and the technology which will be used to develop devices to deliver the exosome treatments by aerosol.

Dr Ronan MacLoughlin, Head of Respiratory Science at Aerogen Limited, said: “Aerogen is delighted to be involved in this potentially transformative project that leans on a unique combination of disruptive technologies. Over 12 million patients have benefited from Aerogen technology to date and we look forward to bringing to bear Aerogen’s unique expertise in this field and working with OmniSpirant and the Centre for Cell Manufacturing Ireland at NUI Galway over the coming years in bringing this technology to patients worldwide.”

The Centre for Cell Manufacturing Ireland (CCMI) at NUI Galway is the first and only approved cell manufacturing facility in Ireland. This purpose-built fully-licensed centre is designed to manufacture Advanced Therapeutic Medicinal Products, such as stem cells, for use in human clinical trials.

Dr Janusz Krawczyk, Clinical Director of the Centre for Cell Manufacturing Ireland (CCMI), NUI Galway, said: “In collaborating with OmniSpirant and Aerogen, the CCMI will apply our unique expertise to develop the manufacturing process of exosome-based therapy. The Centre is ideally placed, with experience and expertise in bringing treatments such as this from bench to pre-clinical stage to early clinical trials. I am delighted to see the CCMI involved in a second DTIF project which ensures that this unique resource in Ireland fulfils its translational potential in stem cell therapy and regenerative medicine. The programme is also aligned with NUI Galway’s ambition to partner with national and multinational industry to ensure that research discoveries have a beneficial impact on patient care. This partnership will confirm the University’s leadership in world-class research and positions Ireland as a strategic global leader in the development of new regenerative medicine technology.”

Dr Imelda Lambkin, Enterprise Ireland, said: “The Disruptive Technologies Innovation Fund administered by Enterprise Ireland is a big opportunity for both large companies and SMEs to collaborate with research bodies to produce technologies that have the potential to really change a market or sector. Indeed, the funding awarded to OmniSpirant Limited, Aerogen Limited and NUI Galway to develop a new treatment for Covid-19 will potentially save lives. The third call for the Disruptive Technologies Innovation Fund will open later this month and we strongly encourage companies and researchers with a disruptive idea or technology to apply.”

The Disruptive Technologies Innovation Fund is a €500 million Project Ireland 2040 fund confirmed under the National Development Plan in 2018.

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