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NovaBiotics Announces New Data on Cysteamine (Nylexa™) as an Antimicrobial Resistance Breaker in Multi Drug Resistant Bacteria
[June 18, 2016]

NovaBiotics Announces New Data on Cysteamine (Nylexa™) as an Antimicrobial Resistance Breaker in Multi Drug Resistant Bacteria


NovaBiotics Ltd ('NovaBiotics' or the 'Company'), the Aberdeen (News - Alert)-based clinical-stage biotechnology company, has presented new data showing antibiotic resistance breaking activity of cysteamine at the ASM Microbe conference, taking place in Boston, MA.

The Company presented a late breaker paper outlining how Nylexa™, its parenteral formulation of cysteamine in early stage development, improves the antimicrobial efficacy of antibiotics and reverses multi-drug resistant (MDR) infections.

The active component of Nylexa™ is cysteamine, a molecule which NovaBiotics first discovered as a multi-active antimicrobial in its research into cystic fibrosis (CF) therapy and the clinical trials of its novel CF therapy Lynovex®. The talk highlighted the much broader clinical potential of cysteamine-based products in a wider range of drug resistant and even MDR Gram negative and Gram positive bacterial infections.

NovaBiotics' results show that cysteamine reverses resistance to clinically important antibiotic classes such as aminoglycosides, fluoroquinolones, macrolides, folate pathway inhibitors and beta-lactams. NovaBiotics also presented data to show that cysteamine reverses MCR-1 and other forms of colistin resistance.

Colistin resistance has recently gained much attention in the press because of its over-use in food producing animals (>12,000 tons of colistin used each year in farming). Colistin is often regarded as the antibiotic of last resort for humans against infections such as E.coli, and therefore, resistance to it is a growing public health concern.



Dr Deborah O'Neil, CEO of NovaBiotics, said:

"We have previously shown that cysteamine can increase the sensitivity of pathogens to a broad range of clinically relevant antibiotics and reverses resistance in CF. Today's data shows that this molecule has a much broader utility, as an adjunct antimicrobial for MDR bacterial infections.


"We believe resistance breakers, like Nylexa™ and other forms of cysteamine have the potential, in the shorter term, to breathe new life into a clinician's existing antibiotic arsenal, extending their utility and thereby saving lives.

"For the longer term, we will continue to develop our antibacterial and antifungal therapies, Novamycin® and Novarifyn®, against which resistance development is highly unlikely."

NovaBiotics' other cysteamine product, Lynovex® (NM001), is a late stage orphan drug candidate for the treatment of Cystic Fibrosis related lung disease in oral and dry powder inhaler form. In a phase IIa clinical study, five week exposure to oral Lynovex®, in addition to standard of care antibiotic therapy, reversed single and multi-antibiotic resistance in P. aeruginosa and S. aureus isolates.

Notes to Editors

NovaBiotics

NovaBiotics Limited ('NovaBiotics' or the 'Company') is a private, UK-based anti-infectives focused biopharmaceutical company. The Company has an advanced product portfolio of antimicrobial assets targeting large and important markets with significant unmet clinical needs.

The development portfolio includes the cysteamine-based products - Lynovex®(NM001), oral and inhaled forms, being developed as a novel multi-active orphan therapy for cystic fibrosis and Nylexa™ (NM002), a parenteral formulation for the treatment of MDR infection. In addition, Novexatin for the treatment of onychomycosis, a potential blockbuster outlicenced to Taro Pharmaceuticals, and Novamycin, a novel rapid acting antifungal for aspergillosis and other life-threatening yeast and mould infections.

The Company is also developing earlier stage compounds from its proprietary antimicrobial peptide rational drug design platform.

For more information, please visit the website: www.novabiotics.co.uk.


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