Released: Wednesday 8th December 2021

NovaBiotics Announces First Patient Enrollment into the Cysteamine Domain of REMAP-CAP

NovaBiotics’ NM002 (cysteamine bitartrate) Under Investigation in a Phase 3 Study for Community Acquired Pneumonia, Including COVID-19, Influenzas and Bacterial Pneumonias

Aberdeen, December 8, 2021. NovaBiotics Ltd, a privately held clinical stage company developing novel immune based therapies for life-threatening and life-limiting-diseases, today announced that the first patient has been enrolled into the Randomised, Embedded, Multi-factorial, Adaptive Platform Trial for Community Acquired Pneumonia (REMAP-CAP) study domain in which the Company’s proprietary intravenous (IV) cysteamine bitartrate (NM002) therapy candidate is being trialled as a phase 3 investigational medicine.

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 produced 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 CAP1. 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, PhD, OBE, FRSE, Chief Executive Officer of NovaBiotics, commented: “We are very pleased that enrollment is now underway and hope that as the study progresses, we will see benefit from NM002 in health outcomes for patients with CAP, including COVID-19. We expect that top-line data from this study will be available in 2022 and look forward to pursuing our goal 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.”

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.”

Professor Manu Shankar-Hari, PhD, FFICM, Chair in Critical Care Medicine at King’s College London and the Cysteamine Domain lead in REMAP-CAP, said: “Cysteamine's many biologically plausible mechanisms of actions such as favorable immune effects, antiviral effects and ability to enhance the effects of antibiotics, could potentially benefit patients with CAP. We were therefore keen to properly assess the potential benefit of this treatment in the REMAP-CAP trial, where the study design lends itself to seamlessly test therapies within viral and bacterial infections that cause pneumonia.”

For further information please contact:

Dr. Deborah O’Neil
Chief Executive Officer
Telephone: 0044 (0)1224 711377
Email: deborah@novabiotics.co.uk

Melody Carey
Rx Communications Group
Email: mcarey@rxir.com

https://www.remapcap.org

https://www.nihr.ac.uk

1Confidential DoF 12/21

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About NovaBiotics
NovaBiotics Ltd is a privately held, clinical-stage biotechnology company revolutionizing the treatment of medically unmet, life-threatening and life-limiting diseases with novel, immune-based therapies. A leading innovator with the ambition to transform treatment paradigms in inflammatory, infectious and respiratory disease, the Company’s robust technology and business model has been validated through successful development from invention through to phase 3 clinical development of its most advanced product candidates.

About NIHR
The National Institute for Health Research (NIHR) is the United Kingdom’s largest funder of health and care research. The NIHR funds, supports and delivers high quality research that benefits the NHS, public health and social care, engages and involves patients, carers and the public in order to improve the reach, quality and impact of research, attracts, trains and supports the best researchers to tackle the complex health and care challenges of the future. NIHR invests in world-class infrastructure and a skilled delivery workforce to translate discoveries into improved treatments and services, partners with other public funders, charities and industry to maximise the value of research to patients and the economy. The NIHR was established in 2006 to improve the health and wealth of the nation through research and is funded by the Department of Health and Social Care