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NovaBiotics Initiates Development of Orphan Drug in Cystic Fibrosis

Published: Tuesday, December 17, 2013
Last Updated: Tuesday, December 17, 2013
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Formulation work commences for inhaled forms of Lynovex®.

NovaBiotics Ltd has announced that it has initiated the development of an inhaled form of Lynovex, its treatment for cystic fibrosis (CF).

Lynovex is an orphan drug candidate that breaks down mucus, disrupts and prevents bacterial films and acts as an antibacterial against Gram-negative and Gram-positive respiratory bacteria.

NovaBiotics is working with inhalation formulation specialists at Crystec in Bradford, UK to develop dry powder inhalable forms of the drug. The aim of administering the drug by aerosolisation is to deliver maximum efficiency with lower doses of the treatment targeted directly to the relevant areas of the respiratory tract.

As a maintenance therapy, the inhaled form of Lynovex is intended for the long term control of the chronic lung infections and mucus production associated with CF. In addition, NovaBiotics is investigating a tablet form for Lynovex for use in acute exacerbations of CF and is working with NHS Grampian and the University of Aberdeen’s CF research team to undertake a phase IIa clinical trial of this new formulation, commencing in early 2014.

Dr Deborah O’Neil, CEO of NovaBiotics, said: “Current treatments for cystic fibrosis are limited and by no means wholly efficacious. Multiple therapies are often required but Lynovex could offer the possibility of a multifunctional, single treatment which addresses mucus production, bacterial infections and also persistent bacterial biofilms and I’m excited at the prospect of investigating how an inhaled form can achieve these clinical aims and, in doing so, could improve lung function in CF patients in the long term.”

Peter York, Chief Scientist at Crystec, said: “We are delighted to be supporting NovaBiotics on this project. We believe that bringing together the therapeutic potential of Lynovex with the ‘best in class’ lung delivery performance of Crystec’s engineered particles could represent a ground-breaking treatment for this debilitating disease.”

As Lynovex progresses through clinical trials, NovaBiotics is enhancing its intellectual property and trademark portfolio for this and its other technologies and product candidates. NovaBiotics recently received a US grant for the Lynovex trademark.

NovaBiotics’ collaboration with the Cystic Fibrosis Trust to fund the upcoming phase IIa study will be highlighted as a case study at the UK Bioindustry Association’s Annual Parliament Day on 30 January 2014, a flagship advocacy event which represents the sector’s top policy needs to senior policymakers across government and sets the agenda for the year ahead.

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