NovaBiotics Ltd
Cruickshank Building
Craibstone
Aberdeen
AB21 9TR,
UK
Novexatin® demonstrates significant antifungal (fungicidal) activity against a broad range of clinical dermatophyte and non-dermatophyte fungal strains; the organisms that cause or are associated with fungal nail infections and other related dermatological tinea infections. Activity has even been observed against strains known to be resistant to currently available treatments (e.g. azoles etc).
Novexatin® is a rapidly fungicidal peptide (within 3 hours of fungal contact). The primary mode of action of Novexatin® is membranolysis and as such, both non-metabolising and metabolically active fungi are susceptible. Importantly, the fungicidal activity of Novexatin® is not compromised by the presence of keratin (the major component of human nail), unlike some other nail fungus treatments.
Resistance Development
Resistance of dermatophyte fungi to Novexatin® has not been observed in vitro, even after multiple exposure cycles/passages.
A randomised, blinded, placebo-controlled, first-in-man clinical programme for Novexatin® commenced Q2/2009.
Phase I of clinical development successfully concluded in Q3/2009 and demonstrated safety, tolerability and lack of systemic exposure of the drug in 12 patients with mild-to-moderate onychomycosis.
A follow-on phase IIa study is now complete (Q2/2010). Data obtained from 48 patients dosed daily with Novexatin® for 28 days confirmed the drug's safety, tolerability and pharmacokinetic profile following multiple dosing. Microbiological and clinical analysis of samples of the patients' nails following exposure to Novexatin® for 28 days provided excellent initial evidence of the drug's efficacy (even at 6 months follow-up) and a phase IIb efficacy study is expected to commence H1 2011.
Once-daily application of Novexatin® (brush-on delivery in a rapidly drying solution) clears fungal infections (dermatophyte and Candida infections) from full thickness toe nails within 28 days. This demonstrates the ability of Novexatin® to penetrate through the nail and remain bioavailable therein; a feature also confirmed by biochemical/radiochemical assays which measure the extent to which Novexatin® penetrates through toe nails. See [NovaBiotics' ex vivo nail model] for more information on the nail model used.
