Ablynx
Brussels : ABLX

May 25, 2011 12:06 ET

Ablynx to Present Clinical Data on Its Anti-RANKL Nanobody at the Annual European Congress of Rheumatology

GHENT, BELGIUM--(Marketwire - May 25, 2011) - Ablynx [Euronext Brussels: ABLX] today announced that it will present Phase I data on its anti-RANKL Nanobody®, ALX-0141, at the Annual European Congress of Rheumatology (EULAR) in London, on 27 May.

Ablynx conducted a first-in-human Phase I trial in healthy post-menopausal women to assess the safety, tolerability, immunogenicity and pharmacokinetics (PK) of a single subcutaneous injection of ALX-0141. In addition, specific bone biomarkers were measured to provide an early indication of efficacy.

The results from this Phase I trial, including the one year follow-up information, indicate that ALX-0141 is well tolerated and can be administered safely over a wide range of doses. All treatment related adverse events were of mild intensity, resolved within the study period and did not result in any withdrawals. Even at the lowest dose, ALX-0141 exhibited a strong and sustained inhibitory effect on bone resorption markers. As such, these data support the advancement into a Phase II clinical trial to investigate whether the early indication of efficacy can be translated into patients. The final immunogenicity data report is expected in Q3 2011 and the Phase II clinical trial is currently expected to start by the end of 2011.

The abstract: "Safety, pharmacokinetics and efficacy of anti-RANKL Nanobody, ALX-0141, in healthy postmenopausal women" is available on the EULAR website at http://www.eular.org. (Abstract No. OP-0198; Oral Presentation on Friday, 27 May at 10.30 am GMT).

Details of the Phase I study

In December 2009, Ablynx initiated a double-blind, placebo-controlled Phase I trial for ALX-0141 in healthy post-menopausal women to investigate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of a single subcutaneous injection of ALX-0141. A total of 42 healthy volunteers were recruited and ALX-0141 was administered via a subcutaneous injection in six dose levels, ranging from 0.003 mg/kg to 1 mg/kg. In addition, serum levels of the lead bone biomarker, CTX-1, were measured to get an early indication of the Nanobody's efficacy.

Complete version of the press release:

http://hugin.info/137912/R/1518830/455321.pdf

This announcement is distributed by Thomson Reuters on behalf of Thomson 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#1518830]

Contact Information

  • 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