Nylexa is a repurposed therapy, already in advanced development for chest infections in CF patients, that can be rapidly deployed as a treatment for COVID-19\. Nylexa is unique and potentially game-changing, because it has multiple targets; the nSARS-CoV-2 virus, the immune response to the infection and also the complications of intractable bacterial infections secondary to SARS-CoV-2 that result in as many as 20% of COVID-19 deaths currently and more than 50% early in the outbreak (in Hubei Province, China). Nylexa is an antimicrobial-immunomodulator with the potential to alter the trajectory of this disease. To save lives and aid better recovery of those infected with less permanent lung damage. It can be rapidly and safely tested (as an intravenously infused drug) in hospitalised COVID-19 patients in the UK and thereafter, worldwide. Nylexa isn't just great science, it is a truly viable solution to COVID-19: Cost effective, readily available and scalable, such that it can be deployed on the global scale required post successful, expedited clinical testing and approvals. NovaBiotics is perfectly positioned to deliver this outcome as a leading biotechnology company developing first-in-class anti-infective and respiratory disease therapies. The business has a track record of developing novel drug candidates from invention to late stage clinical development and commercialisation thereafter through partnerships with pharmaceutical entities with manufacturing and sales-distribution infrastructure. Nylexa could not only be transformational on outcomes of the COVID-19 pandemic, but for NovaBiotics. Nylexa could potentially become NovaBiotics' first approved drug and could pivot the business to profitability, allowing company growth and re-investment in research and development to advance the company's other, potentially life-saving antimicrobial medicines for bacterial and fungal disease, which could have even greater benefit to society and the economy than Nylexa.

Novamycin is a novel antifungal drug being developed by NovaBiotics for front-line treatment of medically unmet, tissue and bloodstream (i.e. invasive) fungal infections caused by difficult to treat moulds and yeasts (including Aspergillus fumigatus and Candida auris). Untreated, invasive fungal disease (IFD) has a mortality rate of 100% and even with treatment, mortality can be as high as in 80% of patients infected with certain fungi. With an ageing global population and medical interventions that suppress our immunity and allow life-threatening fungal infections to establish (chemotherapy for cancer, immunosuppresants, transplant etc.) becoming more commonplace, IFD is occuring more frequently, placing more lives at risk and greater burdens on global health-care systems. There is therefore a clear and urgent need for the development and introduction to clinical practice of new antifungal treatments but a greater awareness of antimicrobial resistance (AMR) against treatments for bacterial infections has overshadowed what is arguably the greater clinical challenge of antifungal AMR. Sufficient progress has undoubtedly yet to be made in providing solutions to bacterial AMR, but research and development in the antifungal sphere is even futher 'behind'. Our solution to this challenge, Novamycin, is active against drug-resistant fungi and has a unique mechanism of action that mitigates opportunites for resistance developing in the future. Novamycin is highly differentiated from existing antifungal treatments (of which there are only 3 main classes versus >10 classes of antibacterial therapy) in how it rapidly kills its target fungi. Novamycin is also not associated with the potentially serious toxicity issues posed by current antifungal treatment options. This is largely because its provenance is the natural antifungal defence system employed by our own bodies and so unlike other antifungal agents that do not always distinguish healthy human cells from a fungal pathogen, Novamycin does not posses any off target pharmacology. The project we propose to undertake will transform Novamycin from a promising, laboratory-stage ‘raw’ antifungal compound to a clinically tested, fully formulated antifungal drug candidate. This would represent a potential breakthrough in advancing Novamycin further towards addressing the significant need for new, safe, effective and resistance limiting therapies for life-threatening invasive fungal infections.

To transfer essential pharmaceutical formulation knowledge and expertise to facilitate the development of a best in class treatment for oral thrush (Oropharyngeal candidiasis).