Clinical Stage Products
Lynovex is a novel, highly differentiated therapy for the treatment of CF-associated lung disease and is intended for use alongside existing standard of care CF therapy to treat all CF genotypes (it is not a mutation-specific intervention). Orphan drug designation has been granted for Lynovex in the US and Europe. NovaBiotics is developing two different formulations of Lynovex; an oral presentation for acute infectious exacerbations (global pre-registration CARE-CF-1 trial now underway. See https://clinicaltrials.gov/show/NCT03000348 and Eudra CT 2015-004986-99) and an inhaled form longer term maintenance and symptom management ( due to commence a clinical POC study in 2017-2018).
Novexatin is a step change in the topical treatment of nail fungus (onychomycosis). Based on the results of studies to date, Novexatin is the first topical agent with the potential to resolve infection and deliver rapid cosmetic benefits with only 4 weeks of treatment vs. 48 weeks for currently available topical treatments. A large phase IIb study is underway with the Company’s global licensing and co-development partner, Taro Pharmaceuticals and results are expected in 2018.
Preclinical Pipeline & Proprietary Antimicrobial Peptide Platform
NovaBiotics is developing its robust pipeline of antifungal and antibacterial candidates including Novamycin and Novarifyn - derived from its proprietary antimicrobial peptide technology platform. This rational drug design approach enables the development of smaller, simpler and therapeutically viable AMP based on endogenous AMP; the cornerstone of the body’s host defence against microbes. The platform is validated by Novexatin and also Luminaderm, a polypeptide currently in clinical development with NovaBiotics' veterinary health pharmaceutical partner for the treatment of bovine mastitis.
Intellectual Assets & Provenance
NovaBiotics has a strong portfolio of granted and pending patents which are wholly owned by the Company. NovaBiotics was founded by our CEO, Dr. Deborah O’Neil in 2004 with the goal of fully developing and realizing the therapeutic and commercial potential of antimicrobial peptides. NovaBiotics is a privately held company, based in Aberdeen, UK & Raleigh, NC, U.S.
A leading innovator in the anti-infectives space, the Company’s robust technology and business model has been validated through successful development, from concept to clinic, of two lead products and securing the most appropriate commercial collaborations to enable the delivery of these highly promising therapy candidates to markets of significant worth.