We are currently completing the preclinical R&D programme for our lead application, a topical treatment for nail fungus (onychomycosis)

Nail fungus (onychomycosis/tinea unguium) is an economically important disease of the toe and finger nails and surrounding skin. It affects as many as 25% of the developed world's population (increasing to 70% in the elderly, immunocompromised and those with peripheral vascular disease). This massive unmet clinical need translates to a potential market worth in excess of £2.5bn.

Nail fungus seriously impacts the quality of life of those affected, causing a great deal of pain, discomfort and embarrassment. Current treatment options for nail fungus, in either tablet or lacquer form, are generally costly, can be lengthy in duration and are generally poor in efficacy. Relapse of the infection following treatment for nail fungus is all too common.

Conventional treatments for nail fungus are associated with a range of serious side effects and toxicity, the most significant being fatal liver and congestive heart failure. Target pathogens are already demonstrating resistance to these therapies

“NovaBiotics' technology has the potential to address both the efficacy and safety shortcomings of current and emergent nail fungus treatments”.

NovaBiotics' lead compound, NP213 is effective against the pathogens that cause fungal nail infection. Importantly, the activity of NP213 is fungicidal, not merely fungistatic (i.e. the compounds actually kill rather than inhibiting the growth of the fungus) providing significantly greater chances of long-term therapeutic benefit.

The mode of action of NP213 is such that resistance is highly unlikely, if not impossible, in the major causative fungal organisms (Trichophyton). NP213 is also effective against other pathogens that co-infect the nail and surrounding skin along with Trichophyton. A major example is Candida albicans, a yeast present in over 30% of nail fungus infections.

Compared to currently available therapies NP213 is unique in its ability to penetrate and remain bioavailable within the nail. As such, NP213 can clear fungal infection from full thickness toe nails very rapidly (see technical summary). Preclinical safety and toxicity regulatory studies have been completed and of note, hepatoxicity studies have shown that at active doses, NP213 is not toxic to liver cells.