What happens when a cystic fibrosis charity and a biotechnology company team up through a partnership? The answer is a Phase IIa clinical trial in the United Kingdom put together by Cystic Fibrosis Trust and NovaBiotics. Also included in the effort are the University of Aberdeen, Health Science Scotland, and NHS Grampian.
“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,” said Dr. Deborah O’Neil, CEO of NovaBiotics, in a news release from the company. “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.”
NovaBiotics will be testing its orally-dosed Lynovex® in cystic fibrosis patients to evaluate the drug’s safety and efficacy. “It is exciting to see how our 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 IIa trial in due course,” said Dr. Janet Allen, Director of Ressearch & Care at Cystic Fibrosis Trust, in a news release from the Trust. “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.”
Patients will receive Lynovex tablets and have their sputum and blood analyzed for bacteria and drug concentration, respectively. Also of interest are lung function, weight, general health, and quality of life. “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,” said Dr. O’Neil. Results are expected in H2 2014.
According to NovaBiotics, the Orphan Drug-designated Lynovex is expected to improve lung function and prevent long-term damage to the respiratory tissues of cystic fibrosis patients. It breaks down mucus and disrupts biofilm formation, two actions that are beneficial to killing bacteria thriving in the lungs of cystic fibrosis patients. “The bacteria causing problems in cystic fibrosis are all too often highly resistant to current antibiotics. By reducing antibiotic resistance, Lynoves could make a real difference to all patients with cystic fibrosis. This is rather exciting,” said Professor Graham Devereux from the University of Aberdeen and Consultant for NHS Grampian.
This Phase IIa trial follows a study that showed Lynovex has an impact on sputum due to is antibacterial and mucolytic activities.