News | News By Subject | News by Disease News By Date | Search News
Get Our FREE
Industry eNewsletter
email:    
   

Ablynx Announces Positive Phase I Results For Subcutaneous Administration Of Its Anti-Thrombotic Nanobody(R) (Alx-0681)



8/18/2009 10:25:31 AM

GHENT, BELGIUM--(Marketwire - August 18, 2009) - Ablynx [Euronext Brussels: ABLX] today announced the positive results from its double- blind, randomized, placebo-controlled, single and multiple dose Phase I study with ALX-0681, a subcutaneous formulation of its novel anti-thrombotic Nanobody® that selectively targets von Willebrand factor (vWF). The positive Phase I data support the progression of ALX-0681 towards Phase II testing in patients with thrombotic thrombocytopenic purpura (TTP), expected to commence in Q2 2010. The anti-vWF Nanobody® received orphan drug designation by the EMEA and the FDA for the treatment of TTP in May this year.

The Phase I study was designed to investigate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of single and repeated subcutaneous administrations of ALX-0681. A total of 36 healthy volunteers were treated with either single subcutaneous doses of ALX-0681 ranging from 2mg to 16mg or daily 10 mg subcutaneous injections for 7 or 14 days.

All administrations of ALX-0681 were well tolerated and did not result in clinically significant adverse events. No signs of local intolerance or clinically significant bleeding events occurred and no evidence of immunogenicity was observed for 45 days after completion of treatment.

The desired biological effect, determined by complete inhibition of a biomarker, was achieved for more than 14 days with daily injections of 10mg of the anti-vWF Nanobody® confirming the biological efficacy of ALX-0681. The PD parameters for coagulation Factor VIII and vWF showed a fast and reversible decrease compared to pre-dose values, with normalisation between 24 and 72 hours after the last administration, depending on dose. The PK profile remained unchanged after multiple administrations, confirming the favourable pharmacological behaviour of ALX-0681.

ALX-0681 is being developed for the treatment of patients with TTP. It is also anticipated that the subcutaneous administration of ALX-0681 will provide access to additional patient populations suffering from unwanted blood-clot formation, such as those with acute coronary syndrome (ACS), which are not currently addressed by the intravenous administration of ALX-0081.


This announcement was originally distributed by Hugin. The issuer is solely responsible for the content of this announcement.


Copyright © Hugin AS 2009. All rights reserved.


For more information, please contact:
For international media enquiries: College Hill Life Sciences
Sue Charles, Justine Lamond,
Dr. John McIntyre
t: +44 (0)20 7866 7857
e: Email 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

Eva-Lotta Allan
Chief Business Officer
t: +32 (0)9 262 00 75
m: +32 (0)475 78 36 21 /
+44 (0)7990 570 900
e: Email Contact


Read at BioSpace.com


comments powered by Disqus
Ablynx
 
 

ADD TO DEL.ICIO.US    ADD TO DIGG    ADD TO FURL    ADD TO STUMBLEUPON    ADD TO TECHNORATI FAVORITES