Aberdeen, UK, 12th March 2018 - NovaBiotics Ltd (NovaBiotics), a clinical-stage anti-infectives biotechnology company, announces receipt of Fast Track Designation (FTD) for its cystic fibrosis (CF) therapy, Lynovex®, from the United States Food and Drug Administration (FDA).
The FDA has granted Fast Track Designation for NovaBiotics‘ orally administered form of Lynovex for the treatment of acute pulmonary exacerbations in CF. Lynovex® is a first-in-class dual mucoactive-antibiotic therapy for CF, currently in a global Phase IIb clinical trial. Fast Track status for oral Lynovex® recognises the potential of Lynovex® to treat CF exacerbations, as evidenced by the clinical and laboratory data generated by NovaBiotics to date, and the seriousness of these events, for which there are no current specific therapeutic interventions. In addition, both the European Medicines Agency (EMA) and the FDA have designated Lynovex® as an Orphan Drug.
Lynovex® is a novel, highly differentiated therapy for the treatment of CF-associated lung disease, with a unique dual mode of action. Lynovex® breaks down the thick, sticky mucus produced by the lining of the airways in CF patients, and kills the bacteria that thrive in this environment and occasionally “flare” as serious chest infections (exacerbations). Lynovex® also boosts the activity of standard-of-care CF antibiotics and is intended for use alongside these and other existing CF therapies as well as the more recently approved ‘disease modifiers’ that can work in certain patients to correct or potentiate the faulty CFTR protein that causes the disease. Importantly, Lynovex® is a therapy designed to treat all CF patients and is not specific to patients with specific mutations/disease genotypes.
Dr Deborah O’Neil, CEO of NovaBiotics, said “Gaining FDA Fast Track designation for oral Lynovex® marks a very significant milestone in the development of this important drug and is recognition of its novelty and its potential clinical impact in CF. Lynovex® has demonstrated significant potential in laboratory tests and clinical trials with respect to providing a meaningful benefit to CF patients when used as an adjunctive therapy to the current standard-of-care drugs. Its potent mucolytic and antimicrobial actions could reduce the impact of acute pulmonary exacerbations and consequently disease progression. Lynovex in oral form is unique as the only therapy specifically designed to tackle exacerbations, despite these events being the main driver of pathology and decline in lung function over time in CF patients.”