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Ablynx's First Inhaled Nanobody Successfully Completes Phase I Study


September 18, 2012 - Ghent, Belgium

ALX-0171 has the potential to become a first-in-class therapy

Ablynx [Euronext Brussels: ABLX] todayannounced that it has achieved positive results from a Phase I study withthefirst ever inhaled Nanobody, ALX-0171, a trivalent molecule which hasbeenspecifically designed by Ablynx for direct lung delivery, via a nebuliser,totreat respiratory syncytial virus (RSV) infections.

The Phase I data showed that ALX-0171 could be successfully administeredvianebulisation directly into the lung in a clinical trial setting, confirmingitspotential as a first-in-class therapy to treat RSV infections. The stabilityofthe Nanobody, together with its specific structure, small size androbustness,make this convenient route of administration possible and provides apotentialsolution to the pulmonary delivery of biologics where antibodies havebeenunsuccessful so far.

The double-blind, randomised trial was conducted in healthy adult malestoinvestigate the safety, tolerability and PK profile of ALX-0171. The PhaseIstudy included a single-ascending dose part in 44 subjects, in which sixdoselevels ranging from 2.1 mg to 210 mg were tested. Subsequent, a multipledosepart was initiated in 16 healthy males, in which the subjects receivedALX-0171, twice daily at a total daily dose of 140 mg and 210 mgrespectively, forfive days.

The Phase I study results indicated that the Nanobody administration waswelltolerated and did not induce any significant clinically relevant adverseeventsor clinically significant changes in lung function, at any of the doselevelstested. In addition, no dose-limiting toxicity or treatment-emergent localorsystemic immunogenicity was observed.

Dr Edwin Moses, Chairman and CEO of Ablynx, said:

"We are very excited about the outcome of this study as we believe it isthefirst time that an antibody-derived drug, which is delivered throughinhalation,has completed a Phase I trial, with no treatment-emergent immunogenicitybeingobserved. This is a major safety breakthrough in the search for potentialnewtreatment options for patients with RSV infections, and furthermore supportsthepotential pulmonary delivery of Nanobodies in a range of lung-based diseasesaswell as offering another route for systemic administration. We arelookingforward to continuing the development of this novel programme and are excitedbythe recent findings of a causal link between RSV infections and asthma whichmayconsiderably increase the potential clinical need for the treatment ofRSVinfections with ALX-0171."

Prof Kris De Boeck, Paediatric Pulmonology, University Hospital inLeuven,Belgium, commented:"RSV infection is the most common cause of lower respiratory tract diseaseandhospital admission in infants. No effective therapy is available atpresent.Current prophylaxis with a monoclonal antibody is expensive and onlypartiallyprotective. Any new treatment strategy for RSV bronchiolitis is very welcome."


About Respiratory Syncytial Virus (RSV)

RSV is a respiratory virus that infects the lungs and respiratory tract. Itisthe most common cause of bronchiolitis (inflammation of the small airways inthelung) and pneumonia in children under one year of age. It is the leadingcauseof infant hospitalisation and also a leading cause of virus-associated deathsininfants. There are more than 300,000 infant hospitalisations in the sevenmajorpharmaceutical markets (USA, Japan, Germany, France, UK, Italy, Spain) andthereported infection rate is 70-80% in children under two years old. Themortalityrate for hospitalised patients is less than 1% in healthy children but 3.5%inthose with high risk conditions. Today, treatment is mostly symptomaticandthere is a high need for an effective specific anti-RSV drug.

About Ablynx

Ablynx is a biopharmaceutical company engaged in the discovery anddevelopmentof Nanobodies®, a novel class of therapeutic proteins based onsingle-domainantibody fragments, for a range of serious human diseases,includinginflammation, haematology, oncology and pulmonary disease. Today, theCompanyhas approximately 25 programmes in the pipeline and seven Nanobodies atclinicaldevelopment stage. Ablynx has ongoing research collaborations andsignificantpartnerships with major pharmaceutical companies, includingBoehringerIngelheim, Merck Serono and Novartis. The Company is headquartered inGhent,Belgium. More information can be found on www.ablynx.com.

press release in pdf:http://hugin.info/137912/R/1641653/528720.pdf

This announcement is distributed by Thomson Reuters on behalf ofThomson Reuters clients. The owner of this announcement warrants that:

(i) the releases contained herein are protected by copyright and other applicable laws; and

(ii) they are solely responsible for the content, accuracy and originality of the information contained therein.

Source: Ablynx via Thomson Reuters ONE

[HUG#1641653]

For more information, please contact

Ablynx:
Dr Edwin Moses
Chairman and CEO
t: +32 (0)9 262 00 07
m: +44 (0)7771 954 193 /
+32 (0)473 39 50 68
e: Email Contact

Marieke Vermeersch
Associate Director Investor Relations
t: +32 (0)9 262 00 82
m: +32 (0)479 49 06 03
e: Email Contact
Follow us on Twitter @AblynxABLX

M:Communications:
Mary-Jane Elliott
Amber Bielecka
Claire Dickinson
t: +44 207 920 2330
e: Email Contact

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