Royal Papworth Hospital NHS Foundation Trust and Thirty Respiratory (“30 Technology”) will shortly be starting a Phase II clinical trial of a nebulised nitric oxide generating solution (RESP301) to treat chronic infection with Mycobacterium abscessus in patients with cystic fibrosis.
RESP301 is a liquid, administered via a handheld nebuliser, which releases nitric oxide in the upper airways and deep alveolar spaces in the lungs, to kill viruses and bacteria and boost a person’s immune response. In laboratory testing, it has demonstrated potent activity against many bacterial species including M. abscessus and also viruses including various influenza and coronavirus strains.
Called NOMAB, the study is to be conducted at Royal Papworth Hospital in Cambridge, one of the UK’s leading centres for cystic fibrosis.
Patients will be treated with RESP301 over a 28-day period and the principal aim of the study is to measure the changes in the amount of the mycobacteria in the lungs before and after treatment. The study will also assess improvements in lung function and will be project managed by Dr Sarah Fielding from Papworth Trials Unit Collaboration at Royal Papworth Hospital.
Professor Andres Floto, the Research Director of the Cambridge Centre for Lung Infection (CCLI), Professor of Respiratory Biology at the University of Cambridge and co-chief investigator for the study, said: “Infection with M. abscessus is a major problem for people with cystic fibrosis, is very difficult to treat, leads to accelerated lung damage, and can prevent safe lung transplantation.”
Dr Charles Haworth, co-chief investigator for the study and a respiratory consultant at the CCLI at Royal Papworth Hospital, added: “Lung infections in people with cystic fibrosis are becoming harder to treat due to the increasing prevalence of multi-drug resistant organisms such as M. abscessus. We urgently need new and effective approaches to combat these infections.”
“The trial follows an extensive program of pre-clinical studies, conducted by Professor Floto’s group at the University of Cambridge Molecular Immunity Unit, that have shown the potent efficacy of RESP301 against M. abscessus and other serious organisms responsible for lung infection” said Dr Keith Lipman, Group Executive Director at 30 Technology.
Initially 12 subjects will be recruited and, if successful, 30 Technology will expand to a larger trial that broadens the scope of RESP301 in cystic fibrosis and other lung conditions.
Chief Medical Officer at 30 Technology, Professor Chris Wood, said: “RESP301 is currently in multiple clinical trials to treat COVID-19 and chronic obstructive pulmonary disorder (COPD) exacerbations but the NOMAB study takes this medicine to another level and into a major new sphere of therapeutic potential.”