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.
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.
The FDA granted Fast Track Designation for oral Lynovex for CF exacerbations in February 2018 and or plans are to progress this candidate into pivotal (PhIII) clinical trials in 2019. Preclinical studies continue for the inhaled form of Lynovex with clinical studies anticipated as getting underway in 2019.