30 Technology gets the go-ahead for multicentre clinical trial (CORVIS) in the UK of RESP301 in patients with COPD and viral exacerbations, including COVID-19

New treatment to protect lung disease patients from COVID-19
London, UK, 18 December 2020.
Thirty Respiratory (“30 Technology”) announced today that the Medicines and Healthcare products Regulatory Agency (MHRA) has approved its application to conduct a new multicentre, open label clinical trial of an inhaled nitric oxide generating solution (RESP301) in up to 150 people in the community with COPD or bronchiectasis and at risk of respiratory viral infections, including COVID-19.

“The CORVIS study is the second clinical trial we are running in COVID-19” said Syd Hanna, 30 Technology’s Executive Director. He added “whereas our first trial, NOCoV2, continues to enrol hospitalised patients with COVID-19, the CORVIS study is a first of its kind for patients in the community who are at high risk because of their underlying lung disease and provides an easy to administer nebulised treatment for patients in their home setting.”

RESP301 is a nitric oxide (NO) generating medication that the patient inhales from a simple hand-held nebuliser. The fine particle droplets release NO into the lungs and upper airways. NO is produced normally in healthy lungs and is the first line of defence against viral or bacterial infection. In COVID-19 and in some respiratory conditions, the NO production can be impaired. RESP301 replenishes the NO, attacks viruses and helps boost the body’s immune system.

Patients in the community with pre-existing respiratory disease are at higher risk of adverse outcomes due to exacerbations caused by SARS-CoV-2 or other respiratory infections. CORVIS will assess the feasibility of recruiting and retaining these patients and treating them with RESP301 in their homes at the onset of viral infection symptoms during the winter months. Up to 150 patients with known COPD will receive an initial RESP301 treatment and return to their homes. In the event that patients develop a respiratory viral exacerbation any time in the following year, their 7-day RESP301 treatment will be dispensed to their home for immediate treatment of the exacerbation with remote consultation from health care professionals at the CORVIS study sites.

The study’s Chief Investigator, Professor Tony De Soyza, Professor of Pulmonary Medicine at Newcastle University, said “The winter months are a serious concern for our patients with COPD because of the serious threat of viral infection. COVID-19 has added to our worries and presents a major threat to these at-risk patients. We are delighted that RESP301 might provide an effective treatment for these patients”.

The patients will be recruited in Newcastle at the NIHR National Patient Recruitment Centre, Newcastle, and in Manchester at the Medicines Evaluation Unit Ltd.

About RESP301

RESP301 is a NO-generating liquid designed to release NO in situ in the upper airways and deep in the alveolar spaces. RESP301 is an admixture solution of two precursor solutions mixed at point of care for immediate inhaled administration via a handheld nebuliser and has specific advantages in treating a range of respiratory viruses, including SARS-CoV-2. In laboratory testing, RESP301 has also demonstrated potent activity against various influenza virus strains, rhinovirus and coronavirus. It has also shown high in vitro activity against other respiratory pathogens, both viral and bacterial. The novel concept for RESP301 is that it will restore the levels of NO in the lungs with a dual action of both killing virus and bacteria and boosting the host response against these pathogenic microbes.

About COPD

Chronic obstructive pulmonary disease (COPD) and bronchiectasis are chronic lung conditions mainly affecting middle-aged or older adults. A Global Burden of Disease report in 2020 estimates COPD as being the 6th largest cause of worldwide disease burden, and the 3rd largest for those 75 years and older1. Bronchiectasis is less common but affects ~300,000 people in the UK and sadly around 1,000 people die each year from the disease in England and Wales2.

COPD is characterised by chronic obstruction of lung airflow that interferes with normal breathing and is not fully reversible. COPD patients are prone to worsening of symptoms and lung function due to infection; these episodes are known as exacerbations. The frequency of exacerbations tends to increase in line with the severity of the underlying COPD. Furthermore, exacerbations contribute to the progression of the condition, being associated with a rapid decline in lung function and increased mortality.

One in eight emergency admissions in the UK is due to a COPD exacerbation, making it the second most common cause; 31% of patients were re-admitted to hospital within 30 days3. Exacerbations of COPD patients are most often caused by respiratory viruses, which tend to lead to more severe symptoms and hospitalisation; other triggers are bacterial infections, air pollutants and ambient temperature.

About 30 Technology

30 Technology is a privately owned biopharmaceutical company developing proprietary NO-generating technologies. The products that 30 Technology have developed have very broad application in many areas of medicine. Efficacy of the technology has been confirmed in large-scale clinical trials.4,5 A dermatology treatment using the NO-generating solution has been shown to have better and faster healing of diabetic foot ulcers than the current standard of care for this condition6. The NO-generating solution being used in the CORVIS and NOCoV2 studies has even greater potential in other common viral respiratory infections and many lung conditions for which infection is a major cause of morbidity and mortality.

For further information, please contact: press@30.technology

References

1 GBD 2019 Diseases and Injuries Collaborators, 2020

2 Roberts and Hubbard, 2010)

3 British Thoracic Society, 2012; Devon LPC and Mediapharm, 2014

4 Edmonds ME, Bodansky HJ, Boulton AJM, Chadwick PJ, Dang CN, D’Costa R et al. Multicenter, randomized controlled, observer-blinded study of a nitric oxide generating treatment in foot ulcers of patients with diabetes-ProNOx1 study. Wound Repair Regen. 2018; 26(2):228-237

5 Waite RD, Stewart JE, Stephen AS, Allaker RP. Activity of a nitric oxide generating wound treatment system against wound pathogen biofilms. Int J Antimicrob Agents.2018; 52(3):338-343

6 Ali-Ahmad D, Bonville CA, Rosenberg HF & Domachowske JB. Replication of respiratory syncytial virus is inhibited in target cells generating nitric oxide in situ. Front Biosci. 2003; 8:a48-53

30 TECHNOLOGY is developing and defining new models of care to treat many serious medical conditions by enhancing the body’s healing and defence mechanisms.

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