Licensing Deal For NP213 Nail Fungus Treatment Is Another Key Milestone For NovaBiotics

NovaBiotics Ltd, the clinical-stage anti-infectives biotechnology company, today announced that it has entered into a licensing agreement with an undisclosed partner to commercialise its NP213 peptide in a topical (brush/paint-on) nail fungus treatment.

Under the terms of the agreement, NovaBiotics’ commercial partner has exclusive rights in major territories including Europe and Japan (excluding the United States) to market a new topical treatment for mild to moderate nail fungus (onychomycosis) containing NovaBiotics’ proprietary NP213 peptide. Launch of the product as a medical device by the commercial partner via direct-to-consumer healthcare channels such as retail pharmacies is anticipated in 2022. The terms of the agreement are such that NovaBiotics will receive development milestone payments prior to launch and sales royalties thereafter.

Dr Deborah O’Neil, CEO of NovaBiotics, commented:

“We are delighted to have secured not only the most appropriate commercial partner but also the best route to market for a nail fungus product based on NP213. The licensing deal for NP213 is a key revenue-generating inflexion point for NovaBiotics and we look forward to a very successful long-term commercial collaboration with our new partner.”

“NovaBiotics has reached an incredibly exciting stage in its life cycle, not only with recent advancements in our exciting portfolio of therapies for a range of infectious and respiratory disease, but with the commercial landscape for products in this space is more attractive than ever. This is evidenced by the level of recent engagement and interest in our pipeline from the investment and pharma community.”

NovaBiotics has breadth and depth not only across its unique technology platforms and therapy candidates for a range of infectious and respiratory conditions, but also has significant commercial potential in global markets now bolstered by the revenue stream that will be generated through the NP213 licensing deal.

Other recent progress includes NovaBiotics’ novel antimicrobial-immunomodulator, Nylexa®, which is now set to enter phase 3 clinical trials in the UK for COVID-19 and non-COVID pneumonia (in hospitalised patients in ICU settings with mild and severe disease). NovaBiotics secured £1m of UKRI funding to support the manufacture of the Nylexa clinical trial material in 2020.

Lynovex® for cystic fibrosis (CF) is derived from the same aminothiol platform as Nylexa® and is now registration trial-ready in oral form (for infectious pulmonary exacerbations of CF), and phase 1 ready in inhaled form (for the long-term maintenance of respiratory function in CF patients). The next clinical trials for both of the Lynovex® product candidates could commence as soon as H2 2021. NP339, NovaBiotics’ novel antifungal peptide is anticipated as being phase 1 ready as a candidate for invasive fungal disease by H2 2021 and is now being developed as an inhaled antifungal therapy for the treatment of airway infections associated with CF, ABPA and other acute and chronic fungal diseases of the respiratory tract. NP432, derived from NovaBiotics’ antimicrobial peptide platform, is a potently bactericidal peptide and candidate therapy for multidrug resistant bacterial infections.