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Clinical data supports the application of Lynovex® as a novel treatment for the infectious exacerbations associated with cystic fibrosis

Aberdeen, UK - NovaBiotics Ltd, the Aberdeen-based specialty biotechnology company ("NovaBiotics" or the "Company"), today announces the presentation of data from a Phase II a clinical trial of its orphan candidate cystic fibrosis (CF) treatment, Lynovex® (NM001) at ECFS.

Lynovex® (NM001) is being developed by NovaBiotics in oral (capsule) form as the first therapeutic intervention specifically intended to address the infectious exacerbations associated with CF. In parallel, NovaBiotics are developing an inhaled form of Lynovex® for chronic use in CF. In both oral and inhaled form, Lynovex® is intended as an adjunct to standard of care antibiotic therapy.

The data presented at this years' ECFS are from a 10 patient Phase IIa clinical study conducted by Aberdeen University's Professor Graham Devereux and his clinical team at Aberdeen Royal Infirmary. In this study, stable adult CF patients from the Aberdeen CF centre cohort received a range of (increasing) Lynovex® doses over the course of 5 weeks alongside their standard of care therapy regimens. The primary objectives of the study were to assess whether the active component of Lynovex® (cysteamine) was safe and well tolerated by the patients, whether it was absorbed into the bloodstream and from there, reached the lung tissue. The study also monitored any initial evidence of clinical benefit from Lynovex®.

The optimal dose at which the drug was safe and well tolerated and absorbed into the blood stream was determined from the trial, as was confirmation that Lynovex® entered the bronchial secretions of the CF patients. Furthermore, the data generated by Professor Devereux suggests that Lynovex® had positive impacts on a number of clinical parameters measured (sputum bacterial load, sputum viscosity, etc.).

The acute, infectious exacerbations that CF patients can suffer multiple times each year have an irreversible, deleterious impact on lung function and quality of life for CF patients. There is a clear, unmet medical and market need for treatments that are designed specifically to not only target the causative bacteria, but also to alleviate the symptoms which patients suffer during these episodes. In laboratory tests Lynovex® (NM001) has already demonstrated unique multiple properties ideally suited to minimising the impact of exacerbation events. The clinical data generated by the study conducted by Professor Devereux appear to confirm these early findings and go further to support Lynovex's utility as a CF therapeutic in acute exacerbations. The next/final phase of clinical development of this first-in-class CF exacerbation therapy is anticipated to commence within the next 12 months.

Professor Devereux said: "These results are very promising. We were pleasantly surprised because some of the patients improved considerably. The CF team and the CF patients in Aberdeen are very keen to contribute to the development of Lynovex®. The experiences gained by actually giving the drug to people with CF will prove invaluable in the development of Lynovex®".

Dr Deborah O'Neil, CEO of NovaBiotics, said: "This encouraging data is a key step in the development of Lynovex® as a much needed therapy in CF exacerbations. At the optimal dose, the drug was not only well tolerated and absorbed by the patients, but reached the lungs in the concentration ranges at which we know this molecules' potent mucolytic and antibacterial effects can be elicited." She adds, "This trial was only the first study of Lynovex® in adult CF patients, but a very carefully designed one by Prof Devereux that generated meaningful, and in some cases striking findings on which we are already building the final clinical trials required for Lynovex® to be marketed for CF in Europe, the US and elsewhere. From my perspective, this data goes further to support the potential breakthrough that Lynovex® may offer in CF".