London, UK, 22 October 2020.
Thirty Respiratory Ltd (“30 Technology”) announced today that the first patients have been enrolled in the multicentre Phase 2/3 NOCoV2 trial of its leading antiviral product, RESP301, as a treatment for patients hospitalised with COVID-19. The aims of the study are to provide an effective treatment for infection from SARS-CoV-2, the virus responsible for COVID-19, and prevent hospitalised patients from needing intensive care and assisted ventilation.
Dr Mohammed Munavvar, Consultant Chest Physician/Interventional Pulmonologist at Lancashire Teaching Hospitals NHS Foundation Trust, Preston, UK, treated one of the first patients; he said, “This is a very innovative treatment for COVID-19 and we are really pleased with the way the patient has responded. We are actively recruiting patients to the study. This novel, easy-to-administer therapy has come at a good time to deal with the second wave of the pandemic.”
Patients are given a proprietary inhaled medicine (RESP301), delivered as a fine particle mist via a portable handheld nebuliser, which reaches into the lungs and releases nitric oxide (NO) at the site of virus infection and lung inflammation.
NO is the body’s natural defence against virus infection,1 but coronaviruses suppress the lung’s normal NO-stimulated innate immune response.2 RESP301 replenishes the NO supply in the airways and boosts the innate immune response. It also attacks the virus directly and reduces host cell metabolism – a means by which the virus replicates in humans.3 RESP301 has shown potent activity in the laboratory against the SARS-CoV-2 virus, plus a range of other pathogenic respiratory viruses and bacteria.5,6,7
Professor Onn Min Kon, Professor of Respiratory Medicine at the National Heart and Lung Institute, Imperial College London, UK, and Principal Investigator for the NOCoV2 study, added, “We urgently need effective ways to treat this virus infection, and RESP301 is such an intuitive way of delivering nitric oxide. We are optimistic that this might be a real advance in combating this disease.”
The NOCoV2 study is treating patients in hospital with COVID-19 and aims to speed their recovery and prevent the progression to more severe forms of the disease.
Professor Chris Wood, Chief Medical Officer at 30 Technology, said, “RESP301 has shown such strong activity against COVID-19 and influenza that we are planning to test it in a broader patient population in primary and secondary care, including those with underlying lung disease and at risk of viral exacerbations. We are also planning prevention studies to treat groups of individuals in large communities, such as university campuses and workplaces.”
RESP301 is a liquid medication designed to release NO in a way that mimics the body’s physiological response to viral or bacterial contamination within the lungs. It is delivered to the airways as a fine particle mist via a handheld nebuliser. NO is produced widely in the human body and is our natural defence against invading organisms.1 In extensive laboratory testing, RESP301 has shown potent activity against a range of pathogenic respiratory bacteria and viruses, including SARS-CoV-2, the virus responsible for COVID-19.2-4 All the constituents in RESP301 have been thoroughly tested in humans and found to be well tolerated.8
About the NOCoV2 study
The NOCoV2 clinical trial is a multicentre randomised study of a new antimicrobial medicine in patients hospitalised with COVID-19. It aims to improve the time to healing from the infection, reduce the risk of disease progression and prevent patients needing intensive care or assisted ventilation. Patients are randomised to receive either RESP301 plus standard of care or standard of care alone. The purpose is to assess the potential value of adding RESP301 to the existing treatment for the patient.
About 30 Technology
30 Technology is a privately owned biopharmaceutical company developing a proprietary NO-generating technology. 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.9,10 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 condition.6 The NO-generating solution being used in the COVID-19 study 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.
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2 Fehr AR, Channappanavar R, Jankevicius G, Fett C, Zhao J, Athmer J, et al. The Conserved Coronavirus Macrodomain Promotes Virulence and Suppresses the Innate Immune Response during Severe Acute Respiratory Syndrome Coronavirus Infection. Amer Soc Microbiol. 2016; 7:1-12.
3 Data on file.
4 Data on file.
5 Regev-Shoshani G, Vimalanathan S, McMullin B, Road J, Av-Gay Y, Miller C. Gaseous nitric oxide reduces influenza infectivity in vitro. Nitric oxide. 2013; 31:48-53.
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.
7 Akerström S, Gunalan, V, Keng CT, Tan YJ, Mirazimi A. Dual action of nitric oxide on SARS-CoV replication: Viral RNA production and palmitoylation of the S protein are affected. Virology. 2009; 395;1-9.
8 Rix PJ, Vick A, Attkins NJ, Barker GE, Bott AW, Alcorn Jr. H, et al. Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of Nebulized Sodium Nitrite (AIR001) Following Repeat-Dose Inhalation in Healthy Subjects. Clin Pharmacokinet. 2015; 54:261–72.
9 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.
10 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.