- ALX-0171 is a first-in-class anti-RSV Nanobody® administered via inhalation
- ALX-0171 was well tolerated in multiple Phase I clinical studies in adults
- ALX-0171 has demonstrated a strong therapeutic effect in a neonatal animal model for infant RSV infection
GHENT, Belgium, Dec. 17, 2014 (GLOBE NEWSWIRE) -- Ablynx [Euronext Brussels: ABLX] today announced that it has opened recruitment in the initial clinical centres for the first-in-infant Phase IIa study with ALX-0171, administered through inhalation. ALX-0171 is a trivalent Nanobody developed for the treatment of Respiratory Syncytial Virus (RSV) infections. Currently, there are no widely used anti-RSV therapeutic drugs available.
The Phase IIa study is a multi-centre, multi-country trial to evaluate the safety, tolerability and clinical activity (including effect on feeding, respiratory rate, wheezing, coughing and general appearance) of ALX-0171, administered via inhalation, in otherwise healthy infants and toddlers (aged 5-24 months) diagnosed with RSV and hospitalised for a lower respiratory tract infection. The study will be run in five European countries with potential additional sites available in the Southern Hemisphere as risk mitigation for the unpredictable length and severity of the European RSV season.
The study consists of two parts. The first part is an open-label "lead-in" part to assess the safety of ALX-0171 in five patients who will receive a once-daily inhaled dose of ALX-0171 for three consecutive days. Following a positive recommendation after review of these "lead-in" safety data by an independent data monitoring committee (DMC), 30 patients will be enrolled in the subsequent double-blind, placebo controlled part of the study in which patients will be randomly assigned to receive either, a once-daily inhaled dose of ALX-0171 or placebo, for three consecutive days.
Dr Steve Cunningham, Department of Respiratory and Sleep Medicine, Royal Hospital for Sick Children, Edinburgh, UK, commented:
"RSV infection is the most common cause of lower respiratory tract disease leading to hospital admission in infants. It is often associated with continued coughing or wheezing after the acute phase of the infection and evidence is accumulating that it increases the risk of asthma later in life. There is a high unmet medical need as there is no effective therapy available at present. Current prophylaxis with a monoclonal antibody is expensive and only partially protective. Any new treatment strategy for RSV bronchiolitis is therefore very much welcome."
Dr Edwin Moses, CEO of Ablynx, added:
"This is a very exciting time for Ablynx and we are pleased that we are moving forward according to plan with our first inhaled Nanobody, ALX-0171, which we believe has great potential for the treatment of RSV infection in infants, a serious and sometimes life threatening disease with a high unmet medical need and which we believe causes a huge burden on parents and has a significant health economic impact to society. If recruitment goes to plan, then the study is expected to be completed in Q2 2015 with results anticipated in Q3 2015. With ALX-0171, Ablynx could potentially achieve its fourth clinical proof-of-concept for Nanobodies and its first for a Nanobody that is administrated through inhalation."
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 and it demonstrated to have a strong therapeutic effect following administration via nebulisation in a neonatal animal model for infant RSV infection1. Repeated daily inhalation of ALX-0171 was proven to be well-tolerated in multiple Phase I clinical studies, including a study in subjects with hyper-reactive airways. At the end of September 2014, the European Medicines Agency (EMA) approved the Paediatric Investigation Plan (PIP) for ALX-0171.
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 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 age. In addition, RSV infection is 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
t: +32 (0)9 262 00 07
m: +44 (0)7771 954 193 /
+32 (0)473 39 50 68
Associate Director Investor Relations
t: +32 (0)9 262 00 82
m: +32 (0)479 49 06 03
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Ablynx media relations Consilium Strategic Communications:
Mary-Jane Elliott, Jonathan Birt, Amber Bielecka, Lindsey Neville
t: +44 203 709 5700
 Hall et al, NEJM, 2009; extrapolation based on estimated US prevalence
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