Novel approaches to treating medically unmet bacterial and fungal infections and tackling antimicrobial resistance

NovaBiotics’ platform technologies leverage defense strategies of the innate immune system and provide first-in-class antibacterial and antifungal therapies with potent activity against drug-resistant infections.

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Antimicrobial resistance (AMR) is a well-established challenge that has a potentially catastrophic impact both in terms of human health and global economic performance. NovaBiotics, a UK-based biotech with an equal focus on antibacterials and antifungals, is taking a unique approach to addressing AMR in many ways.

NovaBiotics has developed a novel approach to the challenge of infection and AMR by address­ing the problem from the host’s perspective and harnessing ‘AMR status-agnostic’ components of the innate immune system that normally deal with infection. In nature, antimicrobial peptides (AMPs) and aminothiols form the cornerstone of the body’s first line of defense against the spectrum of poten­tially harmful microbes with which people come into contact daily. NovaBiotics has developed plat­forms that can harness the beneficial properties of these natural, infection-fighting agents, which have already yielded novel classes of compounds that tar­get a range of fungal, bacterial and polymicrobial infections. This ‘smart immunology’ approach has already been useful in other therapeutic condi­tions, most notably oncology and inflammation. Indeed, eight of the top fifteen best-selling drugs are immune-derived biologics.

Delivering first-in-class drug candidates

NovaBiotics’ AMP platform is generating novel, synthetic antibacterial and antifungal peptide drug candidates with membrane-targeted, rapidly microbicidal modes of action. These compounds are derived, but wholly distinct from endogenous AMPs. They share common, highly desirable prop­erties with their endogenous AMP predecessors, including a rapid kill time and activity against a broad range of fungal, bacterial and polymicrobial infections, including multidrug-resistant pathogens, but are synthetic, therapeutically viable, novel pep­tide structures. While the use of such compounds as potential antimicrobials has been debated and anticipated for some time, the potential of AMP has not yet been fully realized. NovaBiotics has been able been able to re-engineer undruggable host defense peptide structures to create viable antimi­crobial candidates that have demonstrated potent activity against so-called ESKAPE (Enterococcus fae­cium, Staphylococcus aureus, Klebsiella pneumoniae, Acinetobacter baumannii, Pseudomonas aeruginosa and Enterobacter spp.) and other key bacterial pathogens, as well as a range of fungal pathogens including drug-resistant Candida spp., Aspergillus spp. and other yeasts and moulds.

Preclinical-stage candidates derived from the AMP platform include Novarifyn (NP432), a potent bactericidal peptide that outperforms traditional therapy classes in terms of kill time; Novamycin (NP339), an antifungal peptide with placebo-like safety unheard of in antifungals active against Aspergillus, Cryptococcus and Candida spp., as well as emerging fungal pathogens (anticipated to enter clinical development in 2019); and Luminaderm (NP108), which has demonstrated efficacy in the nasal decolonization of Staphylococcus spp. and outperforms the current ‘gold-standard’ decoloni­zation agent, mupirocin, in its bactericidal activity against methicillin-resistant S. aureus.

The company’s second platform is underpinned by cysteamine, an endogenous aminothiol pro­duced in mammalian cells as a result of coenzyme A metabolism through the activity of the vanin fam­ily of pantetheinase ectoenzymes. Cysteamine has antibiotic, antibiofilm and antivirulence properties, as well as being a potent, broad-spectrum chemo­potentiator that improves the performance of other existing antibiotic classes.

The leading drug candidate in NovaBiotics’ pipe­line to emerge from the cysteamine platform is Lynovex (NM001), which provides a completely novel approach for treating the symptoms of cys­tic fibrosis (CF)-associated respiratory infections in all CF patients, regardless of CFTR genotype and/ or mutation status. Lynovex, which is also potently mucolytic and therefore represents a breakthrough in CF treatment, has orphan drug designation in both the US and Europe and fast-track designation in the US. The company is developing two formula­tions of the molecule: Lynovex Oral, which is cur­rently in phase 2 trials as a treatment for CF exacer­bations, and Lynovex Inhaled, a chronic CF therapy that is set to enter clinical development in 2019.

Also derived from the same aminothiol platform as Lynovex, NovaBiotics is developing Nylexa (NM002), an antibiotic potentiator and resistance-breaking agent with utility and scope against drug-resistant (even multidrug-resistant and extensively drug-resistant) bacterial infections that boosts and reinvigorates the effectiveness of poorly perfoming or ‘defunct’ (because of resistance) antibiotics (as well as being an antibiotic in its own right).

Pipeline and platform potential

“Drug candidates from both platforms have mecha­nisms of action that are agnostic to the antimicrobial resistance status of target pathogens and minimize, if not negate, the development of future acquired resistance,” said Deborah O’Neil, CEO of NovaBiotics.

NovaBiotics has a track record in establishing suc­cessful commercial partnerships (its topical peptide antifungal for fungal nail infection, Novexatin, was outlicensed to Taro Pharmaceuticals in 2013, and an oral form of cysteamine for cystic fibrosis exacerba­tions was outlicensed to an undisclosed partner in 2016). “The deals we have done to date are focused on two very specific products from each of our plat­forms in niche indications and we are now shifting the emphasis towards the fact that we have devel­oped more ‘mainstream’ antimicrobials from the two platforms. These are very commercially attrac­tive products for use against Gram-negative and positive ESKAPE bacterial pathogens (peptides and cysteamine) and moulds and yeasts (peptides). The value of the platforms is worth more than the sum of their individual ‘parts’. Both sets of technology are highly complementary, but are wholly independent platforms,” O’Neil added.


Deborah O’Neil, CEO
Aberdeen, UK
Tel: +44 (0)1224 711377

Go to the profile of NovaBiotics Ltd

NovaBiotics Ltd

NovaBiotics Ltd is a leading clinical-stage biotechnology company focused on the design and development of first-in-class anti-infectives for difficult to treat, medically unmet bacterial and fungal diseases. The Company’s advanced portfolio of antimicrobial therapeutic candidates targets large and important markets with significant unmet clinical needs, including Lynovex (in oral and inhaled form), an orphan drug candidate for cystic fibrosis (CF), Novexatin, a potential step change therapy for onychomycosis (being co-developed with and out-licensed to Taro Pharmaceuticals) and Novamycin, a novel antifungal peptide in development for the treatment of aspergillosis, candidiasis and cryptococcosis. Novexatin and Novamycin are among the first-in-class peptide anti-infectives which the company continues to derive from its proprietary antimicrobial peptide rational drug design platform. Lynovex and Nylexa have been developed as novel antimicrobial adjunct therapies from the company's more recently established aminothiol platform. 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 innate immune system effector based antibacterials and antifungals. NovaBiotics is a privately held company, based in Aberdeen, UK & Raleigh, NC, U.S.

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