30 Technology launches a critical clinical trial of RESP301 in cystic fibrosis patients with serious lung infections

RESP301 to combat antibiotic resistant/refractory infection in people with cystic fibrosis
London, UK, 19 February 2021.
Thirty Respiratory (“30 Technology”) announced today the approval by the Medicines and Healthcare products Regulatory Agency (MHRA) of a Phase II clinical trial of its nebulised nitric oxide generating solution (RESP301) to treat chronic infection with Mycobacterium abscessus in patients with cystic fibrosis. The study is to be conducted at Royal Papworth Hospital in Cambridge, one of the UK’s leading centres for cystic fibrosis.

Professor Andres Floto, the Research Director of the Cambridge Centre for Lung Infection (CCLI) at Royal Papworth Hospital and co-lead 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-lead investigator for the study and a respiratory consultant at the CCLI at Royal Papworth, added “Lung infections in people with cystic fibrosis are becoming harder to treat due to the increasing incidence 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 at Cambridge University laboratories, 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.

The patients will be treated with RESP301 over a 28 day period and the main 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 improvement in lung function in these patients. Initially 12 patients will be studied but, if successful, 30 Technology will expand to a much larger trial that broadens the scope of RESP301 in cystic fibrosis and other lung conditions.

Thirty Technology’s Chief Medical Officer, Professor Chris Wood said “RESP301 is currently in multiple clinical trials to treat COVID-19 and COPD exacerbations but the NOMAB study takes this medicine to another level and into a major new sphere of therapeutic potential.”

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 30 Technology

30 Technology is a privately owned biopharmaceutical company developing proprietary NO-generating technologies. The products that 30 Technology has developed have very broad application in many areas of medicine. Efficacy of the technology has been confirmed in large-scale clinical trials1, and in the laboratory2. A dermatology treatment using the NO-generating technology has been shown to have better and faster healing of diabetic foot ulcers than the current standard of care for this condition1.

The NO-generating solution being used in 30 Technology’s PREVENT, 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 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.

2 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.

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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