First-in-class therapeutic solutions to antibiotic and antifungal drug resistance and the rise of emerging pathogens in a number of complex, medically unmet infectious conditions.
NovaBiotics has adopted a global approach to tackling the need for new anti-infective therapies and the challenges of antimicrobial resistance (AMR). We recognise the complex, polymicrobial, biofilm nature of “real life” infections and as such, are developing not just antibacterial therapies, but also antifungal therapies, antibiofilm agents and resistance breaking technology that can be used alongside antibacterial therapies to extend and expand the lifespan and utility of our existing armoury of antibiotics.
Infectious diseases are responsible for the deaths of 14 to 17 million individuals each year, across the developing and developed world. AMR – a modern epidemic – further compounds the challenges and burdens of infectious disease on healthcare systems the world over.
The limited therapeutic options to combat not only AMR, but even the most common microbial infections is a major health and socioeconomic global concern. Declining new antimicrobial drug approvals and an inadequate pipeline of anti-infective therapies meets at a crossroad with AMR of anti-infectives crisis.
It is not only multi-drug resistant or emerging bacterial infections – particularly those caused by Gram-negative pathogens – for which a new therapeutic approach is urgently required. There is even less choice of treatment options and equally if not more of a drug resistance issue for fungal infections. Medical agencies around the world, including the US Centre for Disease Control and Prevention (CDC) and the World Health Organisation (WHO), have voiced concerns regarding the dwindling pipeline of therapeutics available to treat drug-resistant infections.
NovaBiotics is leveraging its peptide and aminothiol technology platforms, and informed, rational drug design strategy, to generate novel classes of antimicrobial therapies that not only have the potential to meet the need for safer, more effective antifungal and antibacterial treatments, but that have no or very low risk of drug resistance development in target pathogen populations.
NovaBiotics continues to target the most clinically challenging, unmet infections with its therapeutic candidates; these include bacterial and fungal infections associated with cystic fibrosis, aspergillosis, candidiasis/aemia, multi-drug resistant bacterial infections; in planktonic and biofilm form and onychomycosis.
Respiratory Infections – Cystic Fibrosis
Cystic fibrosis (CF) is the most common inherited life-limiting genetic condition in Caucasian populations and is a chronic debilitating disease that affects around 70,000 individuals worldwide.
Cystic fibrosis is caused by a mutation – of which over 1,500 have been identified – in a single gene; one that encodes a key protein (the CFTR) which is required for correct ion transport and fluid regulation across the body’s epithelial barriers, such as the linings of the respiratory and gastrointestinal tracts. The genetic mutation in cystic fibrosis leads to abnormally thick mucus secretions which can impair digestion of food and reduce lung capacity/respiratory function. The mucus creates an ideal environment for respiratory bacteria and so CF patients are much more susceptible to chronic, recurrent lung infections which in turn cause inflammation and even more lung damage. CF respiratory infections have such a serious impact on lung function and long term health outcomes for patients that successful treatment or eradication of these microbes (often multi-drug resistant because of long-term exposure to conventional antibiotics) is paramount to improving prognosis and quality of life.
There is no cure for CF and even in an era of modulator therapies, a complete re-think is clearly required as to how the multi-drug resistant lung infections that cystic fibrosis patients have to battle can be more effectively and safely treated and prevented long-term (without generating yet more drug resistance issues). In addition, better therapies to combat the altered lung physiology and mucus production in cystic fibrosis are also very much sought after. Current antimicrobial and mucolytic treatment options for CF patients are limited, generally have to be administered as complex therapy ‘cocktails’ and are not always, if ever, completely successful in achieving their desired clinical effects.
NovaBiotics approach to tackling CF is completely novel and represents a major breakthrough in CF treatments. NM001 (Lynovex®) is a unique molecule with antimicrobial and mucolytic activity. As such, NM001 (Lynovex®) represents a single therapy that is being developed to tackle multiple – and the major – respiratory symptoms in cystic fibrosis. Importantly, Lynovex is a treatment that can be used by all patients, regardless of their genotype and specific CFTR mutation. Lynovex is being developed in oral form for acute pulmonary exacerbations in CF and also as an inhaled (dry powder inhaler) product for the maintenance of ventilatory function.