Lynovex (NM001)

Lynovex® (NM001) is a first-in-class orphan drug candidate for cystic fibrosis, an inherited life-limiting disease affecting around 70,000 individuals worldwide. NovaBiotics is developing two formulations, oral Lynovex for CF exacerbations, and inhaled Lynovex for long term treatment/maintenance.

Lynovex is a novel, highly differentiated therapy for the treatment of CF-associated lung disease, with a unique multi-action; breaking down of the excessive mucus produced by the lining of the airways, killing of the bacteria responsible for the recurrent respiratory infections and disrupting the biofilms in which they colonise. Lynovex also potentiates the activity of standard of care antibiotics used in CF patients and is used alongside existing therapies to treat all disease genotypes. Lynovex is not a mutation-specific CFTR-targeting intervention. The unique multi-action properties of Lynovex have been demonstrated in in vitro and in vivo studies, as well as an ex vivo sputum study of CF patients.

Orphan drug designation has been granted in the US and Europe for Lynovex in the treatment of CF. Lynovex gained Fast Track Designation in the US in 2018.

Clinical and Commercial Development

Lynovex in oral (tablet) form successfully completed a phase IIa clinical study in 2014/15, demonstrating its tolerability, safety and utility in adult CF patients with stable disease. A phase IIb clinical trial for oral Lynovex in acute infectious CF exacerbations recently completed, with positive top line data reported Positive Top Line Data from the CARE CF 1 Clinical Study of Oral Lynovex in Cystic Fibrosis Exacerbations. Precelinical studies are currently underway for inhaled Lynovex and NovaBiotics intends to initiate clinical studies for inhaled Lynovex in 2019.

To learn more about Lynovex, please visit www.lynovex.com.