CONTEXT: Blurring the lines of real-world research and traditional Phase 3, NovaBiotics announce their intravenous cysteamine bitartrate therapy (NM002) has become part of the REMAP-CAP initiative. REMAP-CAP is a global network of research facilities evaluating multiple treatment options for community acquired pneumonia (CAP), simultaneously at more than 300 sites across 20 countries worldwide. The study is funded by a consortium of government funding agencies including the UK’s NIHR. Interestingly, Novabiotics are hoping to use what is essentially real-world clinical evidence as a registration study in a number of key territories in CAP. We will be watching this approval process closely.
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1. “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.””
2. “ABERDEEN, Scotland, June 21, 2021 /PRNewswire/ — 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).”
3. “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).”
4. “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.”
5. “In addition to the lead NM002 programme and the Company’s other late-stage assets (NM001 for cystic fibrosis, NP213/Novexatin® for onychomycosis), NovaBiotics has generated a robust pipeline of earlier stage, high-value drug candidates including NP339 (Department of Health and Social Care funded programme) for life-threatening, drug-resistant invasive and respiratory fungal disease and NP432 for multi-drug resistant bacterial infections.”