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Ablynx Reports Positive Phase I Data for ALX-0061 in Rheumatoid Arthritis

November 30, 2011 - Ghent, Belgium

GHENT, Belgium, 30 November 2011 - Ablynx [Euronext Brussels: ABLX]todayannounced positive Phase I data from the single ascending dose part of thePhaseI/II study with ALX-0061, the anti-IL-6R Nanobody, in patients withrheumatoidarthritis (RA). Based on these positive interim data, Ablynx hasinitiated amultiple ascending dose Phase II study with ALX-0061 in patients with RA.

During the period April to September 2011, the Phase I study recruited atotalof 28 RA patients who received either placebo or a single dose of ALX-0061,injected intravenously. The single doses ranged from 0.3 mg/kg to 6mg/kg. Thestudy treatment was safe and well tolerated, and the biological effectivedoseswere achieved at the doses established in the pre-clinical studies. Thedose-dependent changes of the assessed biomarkers of early inflammation (C-reactiveProtein, fibrinogen and platelets) were consistent with the inhibitionof theIL-6 pathway.

Following this study, three doses were selected for the Phase IIstudy,including 1 mg/kg every 4 weeks, 3 mg/kg every 4 weeks, and 6 mg/kgevery 8weeks. This proof-of-concept Phase II study, which has been initiatedtoday, isexpected to recruit 36 RA patients. A first read out, includingefficacymeasures (DAS, ACR scores) is anticipated after 12 weeks and a final readout,including biomarker responses, is planned after 24 weeks.

Dr Edwin Moses, CEO and Chairman at Ablynx, commented: "The rapidprogress andthe positive results from this first part of the Phase I/II study with ALX-0061in RA patients gave us confidence to progress our IL-6R programmeinto themultiple ascending dose part of this study. We are on track topotentiallyachieve clinical proof-of-concept by the end of 2012." He added: "Nowtogetherwith the rights to the anti-TNF-alpha Nanobodies which we haverecentlyrecovered, we believe we have an increasingly strong portfolio ininflammation,which includes a number of clinical assets with various modes of actionthathave the potential to address the complexity of RA and otherautoimmunediseases, as not all patients adequately respond to current drugs."

About ALX-0061 (anti-IL-6R)ALX-0061 is a Nanobody binding to the interleukin-6 receptor (IL-6R). Ithas thepotential to be differentiated from the benchmark monoclonal antibodythroughits high potency, high stability and low molecular weight of only 26kDwhichcould translate into superior tissue penetration, attractive PK/PDand asuperior safety and efficacy profile. The Nanobody is half-life extendedwith aNanobody targeting albumin, which is believed to improve the deliveryof theNanobody to inflamed tissues.

The involvement of the IL-6 pathway in a variety of diseases indicatesthatmultiple indications can be pursued with large market potentialincludingrheumatoid arthritis (RA), Crohn's disease, Castleman's disease,multiplemyeloma and systemic lupus erythematosus (SLE).

Complete version of the press release:

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


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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