NovaBiotics Ltd (NovaBiotics), the clinical-stage anti-infectives biotechnology company, today announced the first patients have been dosed in the CARE-CF-1 clinical study (NBTCS-02) investigating Lynovex® as an adjunct therapy in Cystic Fibrosis (CF) infectious exacerbations.
The randomised, placebo controlled double blind study follows promising preliminary Phase IIa data for NovaBiotics’ orphan status drug candidate. The current trial aims to assess the benefits of oral Lynovex®, the hard gel capsule form of the drug, as adjunct therapy to standard of care interventions in CF infectious exacerbations. The study will involve 120 adult patients in Europe and the US and will run throughout the winter exacerbation season.
Cystic Fibrosis is a life-limiting, inherited disease caused by a defective gene which results in lungs, the digestive system and other tissues becoming congested with thick mucus. The presence of the mucus in the airways of CF patients leads to numerous health issues, including chronic and recurrent infections of the lungs and consequent inflammation, reduction of lung function and breathing difficulties. Lynovex® in oral form is the first multi-active therapy (with antibacterial, mucolytic, anti-biofilm and antibiotic potentiating properties) developed to alleviate the symptoms and impact on lung function of infectious exacerbations in CF.
Dr Deborah O’Neil, CEO of NovaBiotics, said “Dosing the first patients with Lynovex® in the CARE-CF-1 study is a significant milestone for the business. This trial marks an important step in a product candidate which has shown significant potential to mitigate the effects of, and the symptoms experienced during, CF infectious exacerbations. These episodes can have a permanent impact on the respiratory function of CF patients and, with Lynovex® in tablet and inhaled form, we are part of the fight to lift the life-limiting restrictions that CF places on people with the condition; we are rigorously focused on harnessing our science and developing drugs so that people with CF live longer, better quality lives”.
The Lynovex® capsules will be taken for 14 days alongside standard of care medication for exacerbations. The therapy is targeted at patients with exacerbations with Gram-negative infection, FEV1 >30% predicted and weight >40kg. Clinical outcomes and microbiology will be assessed to determine the optional dose and dose regimen of Lynovex® and inform the next pivotal phase of pre-registration studies.