Lynovex in tablet/oral (hard gel capsule) form successfully completed a phase IIa clinical study in the UK in 2014/15. This small clinical trial demonstrated its tolerability and safety in adult CF patients with stable disease and the preliminary efficacy data obtained confirmed the drugs potential utility in addressing the symptoms and infectious case of CF associated lung disease. The first part of a global, pre-registration (CARE-CF) clinical trial for oral Lynovex in acute infectious CF exacerbations recently completed and determined the safety and efficacy of Lynovex gel capsules alongside standard of care therapy in the treatment of CF exacerbations in adult patients Positive Top Line Data from the CARE CF 1 Clinical Study of Oral Lynovex in Cystic Fibrosis Exacerbations. Pivotal clinical trials for oral Lynovex in CF exacerbations are anticipated as commencing in 2019.
Preclinical studies are continuing for inhaled Lynovex (delivered by dry powder inhaler) and NovaBiotics intends to initiate a proof-of-concept clinical study for inhaled Lynovex Inhaled in 2019.