NovaBiotics Ltd has announced the initiation of an open label/single arm Phase IIa clinical study to assess the safety, tolerability, pharmacokinetics and initial evidence of efficacy of orally-dosed Lynovex®. The Phase IIa trial will be undertaken in collaboration with the University of Aberdeen and NHS Grampian.
Lynovex® is a candidate therapeutic for cystic fibrosis and has unique multi-functionality. Lynovex® has the potential to break down the mucus produced in the airways of CF patients and at the same time, has been shown to kill the bacteria responsible for the recurrent respiratory infections in cystic fibrosis.
Furthermore, Lynovex® disrupts and prevents the biofilms which these bacteria typically form in the cystic fibrosis airway.
By functioning in this way, Lynovex® could improve lung function and halt or prevent long term damage or degeneration of respiratory tissues in CF patients. Lynovex® has been designated as an Orphan Drug by the EMA.
The trial follows the generation of very promising results from a study in which the antibacterial and mucolytic impact of Lynovex® was determined against sputum samples from cystic fibrosis patients.
The Phase IIa study will determine levels of Lynovex® in the blood and sputum of cystic fibrosis patients after it has been administered in tablet form and will monitor levels of bacteria in sputum, lung function and weight as well as general health and quality of life parameters.
Results from the trial are expected to be announced H2 2014 and are part of the Company’s wider plan to develop orally administered Lynovex® as an intervention in acute exacerbations of cystic fibrosis.
Dr Deborah O’Neil, CEO of NovaBiotics, said: “There has been significant drive from the patients to run this trial and tremendous support from all the collaborators, the University of Aberdeen, Health Science Scotland, NHS Grampian and of course, the Cystic Fibrosis Trust. Each and every one of the stakeholders in this study, the patients especially, agree that cystic fibrosis is an orphan disease that remains totally underserved by current treatments. Everyone involved in Lynovex’s clinical development wants to help deliver new and effective ways to treat this disease. We believe Lynovex® could provide significant benefit to the majority of cystic fibrosis patients and we eagerly anticipate the results of this trial and to be able to progress the product further through an expedited regulatory process towards eventual clinical use.”
Professor Graham Devereux of the University of Aberdeen and Consultant for NHS Grampian, one of the specialists at Aberdeen Royal Infirmary who looks after patients with Cystic Fibrosis, said “The bacteria causing problems in Cystic Fibrosis are all too often highly resistant to current antibiotics, by reducing antibiotic resistance Lynovex® could make a real difference to all patients with Cystic Fibrosis, this is rather exciting.”
Dr Janet Allen, Director of Research and Care at the Cystic Fibrosis Trust said: “It is exciting to see how the Cystic Fibrosis Trust’s partnerships with industry are helping to deliver new and successful ways to help treat this disease and we all look forward to seeing the results of the Phase 2IIa trial in due course. By engaging with partners in research and industry the Trust believes it can help speed up the development of new therapies and treatments such as Lynovex® to further the quality and length of life of all people who have cystic fibrosis.”