The journey of Lynovex from concept to drug candidate began with our discovery of the antimicrobial, antibiofilm, antibiotic potentiating and mucolytic properties of cysteamine, the active ingredient of Lynovex. Importantly, this work was peer reviewed by leading CF and microbiology experts before publication in international journals and presentation at key global CF and anti-infectives conferences. You can read the publications and abstracts in our Lynovex® Latest page.
Orphan Drug Designation was granted for Lynovex for the treatment of CF by the European Medicines Agency's (EMA) Committee of Orphan Medicinal Products (COMP) in 2011 and by the US Food and Drug Administration's (FDA) Office of Orphan Medicinal Products in 2014.
The oral form of Lynovex successfully completed a phase IIa clinical study in the UK, supported by the CF-Trust, in 2015. Data from this trial is now published and was first presented at ECFS in 2015. CARE CF 1 data was presented at both the ECFS and NACFC conferences in 2019.
Work in the laboratory on Lynovex as a CF therapy has continued and in August 2016, a global commercial partner was secured to manufacture, market and sell oral Lynovex. This was an important step further in Lynovex’s journey towards use in the clinic.
NovaBiotics engaged with the regulatory authorities in the US and Europe to move forward with the clinical development of Lynovex in oral and inhaled form. In January 2017, the first patients were dosed in the CARE-CF-1 clinical study involving 98 adult patients experiencing acute exacerbations in The UK, US and Italy. The CARE CF 1 trial recently closed with positive top line data reported on the impact of Lynovex on CF exacerbations when take alongside standard of care therapy see more here: Lynovex.co.uk.
Lynovex in oral (tablet) form recently completed an exploratory phase 2b global study (CARE CF 2) following an earlier, positive phase 2a trial. CARE CF 1 was designed to determine which clinical endpoints are the most appropriate to demonstrate the benefits of Lynovex in exacerbating (adult) CF patients who took Lynovex alongside their other ‘standard’ medicines for 14 days (or placebo). CARE CF 1 was also designed to determine which dose(s) and treatment regimen(s) of Lynovex is/are optimal for efficacy. The endpoint and dose(s) were successfully identified from CARE CF 1 and, following interactions and feedback from the FDA and EMA, Lynovex will be taken forward in a confirmatory phase 2b study (CARE CF 2) and thereafter phase 3 clinical trial (CARE CF 3). Paediatric studies are planned alongside the phase 3 study in adult patients.