ALX-0171 has first-in-class potential for the treatment of RSV infections
On track to start first-in-infant Phase IIa study before the end of 2014
GHENT, Belgium, Nov. 6, 2014 (GLOBE NEWSWIRE) -- Ablynx [Euronext Brussels: ABLX] today announced that it will give an oral presentation on its first inhaled anti-RSV Nanobody®, ALX-0171, at the 9th International Respiratory Syncytial Virus (RSV) Symposium, which is taking place from 9th to 13th November 2014 in Stellenbosch, South Africa.
The presentation will include results from the pre-clinical proof-of-concept study with ALX-0171 in a neonatal lamb model of RSV infection that is of relevance to RSV-infected infants. The results show that once-daily inhalation of ALX-0171 for three consecutive days resulted in a greater than 10,000-fold reduction of viral titres and markedly reduced lung inflammation. This treatment also rapidly alleviated various clinical signs and symptoms of the infection. These results are indicative of the encouraging potential of ALX-0171 in the treatment of RSV infection in infants - an area of high unmet medical need.
The neonatal lamb model is a highly relevant model for infant RSV infection because lambs develop comparable lower respiratory tract infections which are also associated with a decline in general well-being and specific lung pathology. In addition, lambs develop clinical symptoms that are similar to those that develop in infants, such as wheezing. In this proof-of-concept study, treatment with inhaled ALX-0171 was initiated at the peak of viral load (on the third day post-infection when the symptoms were already clearly present) in order to mimic the anticipated clinical situation with infected infants.
The presentation "Delivery of ALX-0171 by inhalation greatly reduces disease burden in a neonatal lamb RSV infection model" will take place on Thursday 13 November 2014 and shortly after the session, the slides will be available on Ablynx's corporate website (via this link).
ALX-0171 has first-in-class potential for the treatment of RSV infection. It is a wholly-owned trivalent, non-half-life extended Nanobody that inhibits RSV replication and which neutralises RSV activity by blocking virus uptake into cells. The physical robustness of the Nanobody allows administration via inhalation directly to the site of infection, i.e. the respiratory tract including the lungs. ALX-0171 has shown a potent anti-viral effect against recent clinical RSV isolates. The Nanobody was well tolerated in multiple Phase I clinical studies in adults.
Ablynx is on track to start the first-in-infant Phase IIa study before the end of 2014.
RSV remains the primary reason for infant hospitalisation and virus associated deaths in infants, hence the need for an effective and specific anti-RSV therapeutic drug. It is estimated that, due to RSV infections, there are more than 300,000 children (aged <5 years) hospitalised each year in the seven major pharmaceutical markets and the reported infection rate is 70-80% in children under two years of age1. In addition, RSV infections are a significant cause of pulmonary disease in transplant patients, immune-compromised subjects and the elderly. Current treatment of patients infected with RSV is primarily focussed on symptomatic relief.
Ablynx is a biopharmaceutical company engaged in the development of Nanobodies®, proprietary therapeutic proteins based on single-domain antibody fragments, which combine the advantages of conventional antibody drugs with some of the features of small-molecule drugs. Ablynx is dedicated to creating new medicines which will make a real difference to society. Today, the Company has more than 30 proprietary and partnered programmes in development in therapeutic areas including inflammation, haematology, oncology and respiratory disease. The Company has collaborations and significant partnerships with pharmaceutical companies including AbbVie, Boehringer Ingelheim, Merck & Co, Merck Serono and Novartis. The Company is headquartered in Ghent, Belgium. More information can be found on www.ablynx.com.
For more information, please contact
Dr Edwin Moses
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+32 (0)473 39 50 68
Associate Director Investor Relations
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Ablynx media relations Consilium Strategic Communications:
Mary-Jane Elliott, Amber Bielecka, Lindsey Neville
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1 Hall et al, NEJM, 2009; extrapolation based on estimated US prevalence
pdf version of the press release http://hugin.info/137912/R/1868989/656976.pdf