- Randomized embedded multi-factorial platform trial to provide accelerated, real-world evidence in community acquired pneumonias including COVID-19, influenzas and bacterial pneumonias
Aberdeen, June 21, 2021. NovaBiotics Ltd, a privately held clinical stage company developing novel immune based therapies for life-threatening and life-limiting-diseases, announces that the Company’s proprietary intravenous (IV) cysteamine bitartrate (NM002) therapy candidate is included in a global Phase 3 clinical trial being conducted and funded as part of REMAP-CAP (Randomised, Embedded, Multi-factorial, Adaptive Platform Trial for Community Acquired Pneumonia).
REMAP-CAP is a global network of expert clinicians, medical institutions, and research facilities with the objective of evaluating treatments with the potential to reduce mortality, intensive care use, and morbidity in severely ill patients with community acquired pneumonia (CAP). This international, adaptive trial is evaluating multiple treatment options simultaneously at more than 300 clinical sites across more than 20 countries worldwide. The study is funded by a consortium of government funding agencies from participating countries, including the United Kingdom’s (UK) National Institute for Health Research (NIHR). NovaBiotics has provided NM002 doses for the initial UK phase of REMAP CAP and has developed a scalable manufacturing process for NM002 to supply the balance of the trial.
NM002 is an immunomodulator-antimicrobial (antiviral and antibacterial) and NovaBiotics’ data suggest that its multi-active properties could provide significant benefit in the treatment of CAP. The active pharmaceutical ingredient of NM002, cysteamine, is an endogenous innate immune effector with an underappreciated role in the treatment of the inflammatory consequences of infection.
Deborah O’Neil, OBE, PhD, FRSE, Chief Executive Officer of NovaBiotics, commented: “We are delighted that NM002 will be included as part of this important global clinical trial. Inclusion as a Phase 3 intervention is key for NovaBiotics as it gives us a second late-stage clinical product and it brings us one step closer to bringing our potentially life-saving, immunology-based treatment to patients suffering with CAP, including CAP caused by COVID-19 and difficult to treat, even drug resistant bacteria.”
“This study can provide real-world clinical evidence in a range of CAPs potentially in thousands of patients across several continents. Our ambition is for REMAP-CAP to serve as a registration study for NM002 in a number of key territories in CAP, an important cause of mortality and morbidity worldwide,” added Dr. O’Neil.
Professor Anthony Gordon, MD, FRCA, FFICM, Chair in Anaesthesia and Critical Care at Imperial College London and the UK Chief Investigator in REMAP-CAP, said: “REMAP-CAP was designed to be an on-going platform to develop effective treatments for severely ill patients with pneumonia. We are, therefore, thrilled to establish collaborations with new partners, such as NovaBiotics, to ensure a growing pipeline of new treatments designed to improve outcomes for some of the sickest patients in hospital.”
Full PR available here