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NovaBiotics drug added to global trial against deadly infection caused by Covid

Researchers at NovaBiotics are developing novel immune-based therapies for life-threatening and life-limiting diseases.
Researchers at NovaBiotics are developing novel immune-based therapies for life-threatening and life-limiting diseases.

A leading biotech company has revealed one of its drug candidates is being used in a worldwide trial to fight pneumonia in critically-ill patients, including those with Covid-19.

Aberdeen-based NovaBiotics said the inclusion of NMoo2, an anti-inflammatory and antimicrobial treatment, in the global study brings the agent “one step closer” to being widely available to help some of the sickest patients around the globe suffering with community-acquired pneumonia (Cap).

What is Remap-Cap?

The study is known as Remap-Cap (Randomised, Embedded, Multi-factorial, Adaptive Platform Trial for Community Acquired Pneumonia) which includes a network of clinicians, medical institutions and research facilities operating more than 300 clinical sites across more than 20 countries. It has already made its mark by proving two rheumatoid arthritis drugs, tocilizumab and sarilumab, significantly improve survival among Covid patients and cut the time spent in hospital by a week to 10 days.

The study is funded by a consortium of government agencies from participating countries, including the UK’s National Institute for Health Research (NIHR).

What is cysteamine used for?

NovaBiotics said the active pharmaceutical ingredient of NM002, cysteamine bitartrate, has an “underappreciated role” in the treatment of the inflammatory consequences of infection. NovaBiotics has used similar formulations of the chemical compound, which is produced naturally in the human body, in its treatment for bacterial lung infections associated with cystic fibrosis (CF).

The company said NM002 is an “immunomodulator-antimicrobial” which means it can act to bolster host immunity as well as fight viral and bacteria infection.

NovaBiotics chief executive Deborah O’Neil.

Deborah O’Neil, chief executive Officer of NovaBiotics, said: “We are delighted that NM002 will be included as part of this important global clinical trial.

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 community-acquired pneumonia (Cap).

Dr Deborah O’Neil, CEO, NovaBiotics

“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.”

Growing the pipeline

Professor Anthony Gordon, 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 ongoing 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.”

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.