Thirty Respiratory gets Regulatory Approval to start international, open-label, randomised, multi-centre Phase 2/3 trial of RESP301 in patients hospitalised with COVID-19
London 18 June 2020.
Thirty Respiratory Limited* a world-leader in Nitric Oxide medical science, today announced the MHRA has given Regulatory Approval for a Phase 2/3 NOCoV2 Study using its leading respiratory formulation (RESP301) in hospitalised COVID-19 patients.
RESP301 has been proven to kill two different strains of SARS-CoV-2 at laboratories in Europe and the USA. This adds to the existing evidence that RESP301 is highly active against many other viruses, including influenza H1N1, as well as drug resistant and drug sensitive bacteria.
RESP301 is a proprietary liquid inhaled via a small, easy-to-use, hand-held nebuliser. RESP301 delivers localised and sustained nitric oxide release throughout the patient’s airways, combining three modes of action:
- direct antiviral kill;
- prevention of membrane fusion of COVID-19’s S-protein to the host cell ACE2 receptor; and
- downregulation of host cell metabolism, inhibiting intracellular virus replication.
The Principal Investigator for the NOCoV2 Study is Professor Onn Min Kon, Imperial College, London, and first patients will be treated shortly. The study will enrol patients in multiple hospitals throughout the UK and internationally.
“Today’s announcement marks a significant milestone in our rapid response to finding an effective treatment for COVID-19 and other viruses. We are also advancing further pivotal studies in wider community-based populations, in preparation for the influenza season and a possible second wave of COVID-19 infections. These studies will be aimed at intercepting COVID-19 in asymptomatic and mildly ill patients”, said Professor Chris Wood, Chairman of Thirty Respiratory.
*Thirty Respiratory Limited is part of Thirty Holdings Limited (trading name 30 Technology).
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30 TECHNOLOGY Therapeutic Nitric Oxide