Date posted: 12-Mar-2018
Aberdeen, UK, 12th March 2018 - NovaBiotics Ltd (NovaBiotics), a clinical-stage anti-infectives biotechnology company, announces receipt of Fast Track Designation (FTD) for its cystic fibrosis (CF) therapy, Lynovex®, from the United States Food and Drug Administration (FDA).
The FDA has granted Fast Track Designation for NovaBiotics‘ orally administered form of Lynovex® for the treatment of acute pulmonary exacerbations in CF. Lynovex® is a first-in-class dual mucoactive-antibiotic therapy for CF, currently in a global Phase IIb clinical trial. Fast Track status for oral Lynovex® recognises the potential of Lynovex® to treat CF exacerbations, as evidenced by the clinical and laboratory data generated by NovaBiotics to date, and the seriousness of these events, for which there are no current specific therapeutic interventions. In addition, both the European Medicines Agency (EMA) and the FDA have designated Lynovex® as an Orphan Drug.
Lynovex® is a novel, highly differentiated therapy for the treatment of CF-associated lung disease, with a unique dual mode of action. Lynovex® breaks down the thick, sticky mucus produced by the lining of the airways in CF patients, and kills the bacteria that thrive in this environment and occasionally “flare” as serious chest infections (exacerbations). Lynovex® also boosts the activity of standard-of-care CF antibiotics and is intended for use alongside these and other existing CF therapies as well as the more recently approved ‘disease modifiers’ that can work in certain patients to correct or potentiate the faulty CFTR protein that causes the disease. Importantly, Lynovex® is a therapy designed to treat all CF patients and is not specific to patients with specific mutations/disease genotypes.
Dr Deborah O’Neil, CEO of NovaBiotics, said “Gaining FDA Fast Track designation for oral Lynovex® marks a very significant milestone in the development of this important drug and is recognition of its novelty and its potential clinical impact in CF. Lynovex® has demonstrated significant potential in laboratory tests and clinical trials with respect to providing a meaningful benefit to CF patients when used as an adjunctive therapy to the current standard-of-care drugs. Its potent mucolytic and antimicrobial actions could reduce the impact of acute pulmonary exacerbations and consequently disease progression. Lynovex® in oral form is unique as the only therapy specifically designed to tackle exacerbations, despite these events being the main driver of pathology and decline in lung function over time in CF patients.”
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About Fast Track Designation (FTD)
FTD is a process designed to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need; defined as providing a therapy where none exists or providing a therapy which may be potentially better than available therapy. According to the FDA, any drug being developed to treat or prevent a condition with no current therapy obviously is directed at an unmet need. If there are available therapies, a fast track drug must show some advantage over available therapy. The purpose of FTD is to allow faster access to important new drugs to patients in the United States. A drug that receives FTD is eligible for some or all of the following: more frequent meetings with the FDA to discuss the drug's development plan and ensure collection of appropriate data needed to support drug approval, more frequent written communication from the FDA about such things as the design of any proposed clinical trials, eligibility for Priority Review, if relevant criteria are met, Rolling Review, so that completed sections of a New Drug Application (NDA) can be submitted for review by the FDA even before the entire NDA is completed. Once a drug receives FTD, early and frequent communication between the FDA and drug company is encouraged throughout the entire drug development and review process. The frequency of communication assures that questions and issues are resolved quickly, often leading to earlier drug approval and access by patients.
About Cystic Fibrosis (CF)
Cystic Fibrosis is a life-limiting, inherited disease caused by a defective gene which results in lungs, the digestive system, and other tissues becoming congested with thick mucus, affecting around 70,000 individuals worldwide. The presence of the mucus in the airways of CF patients leads to numerous health issues, including chronic and recurrent infections of the lungs and consequent inflammation, reduction of lung function, and breathing difficulties. Lynovex® in oral form is the first multi-active therapy (with antibacterial, mucolytic, anti-biofilm, and antibiotic potentiating properties) developed to alleviate the symptoms and impact on lung function of infectious exacerbations in CF.
NovaBiotics Limited (“NovaBiotics” or the “Company”) is a leading global anti-infectives focused biotechnology company. The Company has an advanced product portfolio of antimicrobial assets targeting large and important markets with significant unmet clinical needs. These include Lynovex®, a novel multi-active orphan therapy for cystic fibrosis, Novexatin for the treatment of onychomycosis, Novamycin, a novel rapid acting antifungal for life-threatening mould and yeast blood stream and deep tissue infections, and Novarifyn, a potent antibacterial active against drug resistant and multi-drug resistant Gram-negative and Gram-positive bacterial infections. The Company is also developing earlier stage compounds from its proprietary antimicrobial peptide and cysteamine platforms.
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