TRICAP investee NovaBiotics Ltd has gained Fast Track Designation (FTD) in the USA for its cystic fibrosis therapy, Lynovex®.
The US Food and Drug Administration (FDA) granted the FTD for NovaBiotics‘ orally administered form of Lynovex® for the treatment of acute pulmonary exacerbations in CF.
Dr Deborah O’Neil, CEO of the Aberdeen biotech company, welcomed the FTD as a “very significant milestone” in the development of its novel CF treatment.
She added: “Gaining FDA Fast Track designation for oral Lynovex® 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.”
TRICAP chairman Jamie Andrew welcomed the news, saying, “I’m delighted that the NovaBiotics team has received this recognition for their oral Lynovex® treatment. It’s a significant milestone in the product’s journey to market”.
The FTD comes in addition “Orphan Drug” designation for Lynovex® from both the European Medicines Agency (EMA) and the FDA.
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.
NovaBiotics Limited 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.
Visit the NovaBiotics website for more information.