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Ablynx Initiates Phase I Study With ALX-0171 for the Treatment of Respiratory Syncytial Virus (RSV)

December 13, 2011 - Ghent, Belgium

Ablynx [Euronext Brussels: ABLX] todayannounced that it has initiated a Phase I study in healthy volunteers withALX-0171, the first Nanobody in clinical development to be delivered byinhalation.ALX-0171 is being developed for the treatment of respiratory syncytialviral(RSV) infections.

The Phase I study is a single-centre, randomised, placebo-controlled trialthatwill investigate the safety, tolerability and PK profile of ALX-0171 inhealthyvolunteers. The study will include a single ascending dose part with sixdoselevels, which is expected to recruit 44 subjects, followed by a multipledosepart that is expected to recruit 16 subjects. Results of thestudy areanticipated during the second half of 2012.

Dr Edwin Moses, CEO and Chairman at Ablynx, commented: "We believe thereis ahigh unmet need for a therapeutic treatment of RSV infection. ALX-0171is thefirst Nanobody to enter clinical development that is administeredthroughinhalation rather than injection. It has the potential to become afirst-in-class therapeutic for RSV infections. This alternative route ofadministrationin an acute disease setting is a good example of the competitivedifferentiationand advantages our Nanobody technology platform can bring. We arelookingforward to seeing the results of this first-in-man trial, which areexpectedduring the third quarter of 2012."

About RSV

RSV is a respiratory virus that infects the lungs and respiratory tract.Mosthealthy people recover from an RSV infection within one or two weeks.However,the infection can be much more severe in immune-compromisedindividuals, theelderly, infants with cardio-pulmonary disease and premature babies. RSVis themost common cause of bronchiolitis (inflammation of thebronchioles, thesmallest air passages of the lungs) and Pneumonia in children youngerthan oneyear old, and is increasingly being recognised as an importantcause ofrespiratory illness in the elderly. Today, there are no widelyacceptedestablished antiviral agents available for the treatment of RSV.High-riskinfants can be protected with a prophylactic drug that is used toprotectagainst RSV infections. ALX-0171 has the potential to become a first-in-classtherapeutic for the treatment of RSV and may address an even largerpatientpopulation beyond high-risk infants in the therapeutic setting.

Complete version of the press release:

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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
Investor Relations Manager
t: +32 (0)9 262 00 82
m: +32 (0)479 49 06 03
e: Email Contact


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