NovaBiotics Receives Orphan Drug Status from FDA for Lynovex for the Treatment of Cystic Fibrosis
NovaBiotics has announced that FDA has granted orphan drug designation for Lynovex (NM001), the company’s first-in-class therapeutic candidate for the treatment of Cystic Fibrosis (CF).
It is believed that Lynovex has unique multi-functionality; combined properties of breaking down the excessive mucus produced in the airways of CF patients, killing the bacteria responsible for the recurrent respiratory infections in CF and disrupting/preventing the biofilms which these bacteria typically form in the CF airway. By functioning in this way, Lynovex could improve lung function and halt or prevent long-term damage or degeneration of respiratory tissues in CF patients.
Lynovex is being developed by NovaBiotics for CF as an oral (tablet) form for acute exacerbations and in inhaled (dry powder) form for chronic use and maintenance. Lynovex is intended for application alongside existing CF treatments and potentiates their antimicrobial effects. A Phase IIa clinical trial for the oral form of Lynovex is already underway. Phase IIb studies of the oral form of Lynovex in the UK and Europe are expected to commence in 2015. Clinical development of the inhaled form is also anticipated to get underway in H2 of 2015.
Dr Deborah O’Neil, CEO of NovaBiotics, said: “The orphan drug designation for Lynovex in the US is a major regulatory milestone for NovaBiotics and highlights the unmet need for effective and safe treatments for CF patients. Dosing of the first patients in the Aberdeen Phase IIa clinical trial is also a significant clinical milestone in Lynovex’s clinical development.”
She added: “If the encouraging data we have achieved so far continues to translate in clinical use, we believe Lynovex will offer a breakthrough in the treatment of CF. This is a candidate therapy with the potential to significantly improve the health and quality of life for those affected by CF. Importantly, and unlike other treatments that are specific to particular CF mutations, Lynovex is intended for use by the entire CF patient population, not just sub-groups.”
Related News
-
News CPHI Podcast Series: the power of digital marketing in pharma
Digital marketing is a valuable tool for many industries, and the pharmaceutical and healthcare industry is no exception. The CPHI Podcast Series covers how marketing can be used by companies to increase their engagement and overcome challenges.&n... -
News Novel approach to creating sustainable packaging from rice husks
Researchers have created a new approach to the designing of eco-friendly nanofibres extracted from rice husks, addressing the critical need for sustainable packaging materials in food and biopharmaceutical products. -
News BioNTech to begin mRNA vaccine manufacturing in Rwanda by 2025
German biotechnology company BioNTech has stated their intentions to begin production at their mRNA vaccine factory in Rwanda by 2025, which will mark the first foreign mRNA vaccine manufacturing site on the continent of Africa. -
News Identifying Alzheimer’s Disease biomarker proteins with whole blood tests
A University of Manchester spin-out pharmaceutical company, PharmaKure, has reported successful study results for the quantification of Alzheimer’s Disease biomarker proteins with a whole blood test. -
News Bill & Melinda Gates Foundation to boost mRNA vaccine initiatives in Africa with USD $40m
To address vaccine inequality and accessibility issues, the Bill & Melinda Gates Foundation aims to deliver USD $40m to various biotech companies and vaccine manufacturers in support of mRNA vaccine development. -
News CPHI Podcast Series: Exploring neurological frontiers in Alzheimer's and beyond
The next episode of the CPHI Podcast Series delves into the science and background behind some recent developments in the field of Alzheimer's disease and neurological disorders. -
News Is patient centricity the future of pharmaceutical manufacturing?
In this interview with Sandra Sánchez y Oldenhage, President of PharmAdvice, she speaks to the importance of considering patients in the manufacturing stages of the pharmaceutical supply chain, and how it can redefine healthcare. -
News CPHI Podcast Series: How to leverage AI for Drug Discovery
Artificial intelligence is the topic of debate in the latest episode from the CPHI Podcast Series, where Digital Editor Lucy Chard speaks with Bill Whitford of DPS Group about the integration of AI in healthcare.
Position your company at the heart of the global Pharma industry with a CPHI Online membership
-
Your products and solutions visible to thousands of visitors within the largest Pharma marketplace
-
Generate high-quality, engaged leads for your business, all year round
-
Promote your business as the industry’s thought-leader by hosting your reports, brochures and videos within your profile
-
Your company’s profile boosted at all participating CPHI events
-
An easy-to-use platform with a detailed dashboard showing your leads and performance