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Ablynx Reports Excellent Interim Results From Phase I/II Study With Its Anti-IL-6R Nanobody, ALX-0061, in Rheumatoid Arthritis Patients



10/4/2012 8:42:08 AM

GHENT, BELGIUM--(Marketwire - October 04, 2012) -


  • 60% of patients in DAS28 remission at week 12
  • ACR20 score of 80% at week 12
  • Very encouraging safety profile at all administered doses
  • Rapid onset of activity with some patients achieving remission as early as week 2

Results Will Be Discussed During a Webcast Presentation Today at 15h CET, 9 am EST
Click here to register, call number +32 (0)2 620 01 38

GHENT, Belgium, 4 October 2012 - Ablynx [EURONEXT BRUSSELS: ABLX] today announced that its anti-IL-6R Nanobody, ALX-0061, met the efficacy endpoint of a significant improvement in key indicators of disease activity at the 12 week interim analysis of the Phase I/II study in patients with moderate to severe active rheumatoid arthritis (RA) on a stable background of methotrexate. Final 24 week results are expected in the first quarter of 2013.

In this Phase I/II study, 37 RA patients were recruited to the multiple dose Phase II part. Patients were randomised to three dose groups of intravenously administered ALX-0061 (1mg/kg every 4 weeks, 3mg/kg every 4 weeks and 6mg/kg every 8 weeks) or to placebo. At the week 12 interim analysis, the 3mg/kg dose level of ALX-0061 met the efficacy endpoint in achieving statistically significant improvement in DAS28(1) remission and ACR20(2) scores compared with placebo. Moreover, all dose groups showed impressive results in all efficacy endpoints, with a DAS28 remission of >40% achieved consistently at week 8 and with an onset of remission observed in some patients already at week two.

At all doses tested, ALX-0061 was well-tolerated and the safety profile compared favourably to data reported for other biological DMARDs(3). Additionally, no decrease in neutrophils (white blood cells), no clinically significant increases in liver enzymes and no increases in lipid levels (cholesterol) were observed at the interim analysis.

A total of 34 subjects were eligible for determination of the efficacy endpoints at week 12(4):

----------------------------------------------------------------------------
Efficacy parameter    1mg/kg every  3mg/kg every  6mg/kg every  Placebo     
                      4 weeks       4 weeks       8 weeks       (N=6)       
                      (N=9)         (N=10)        (N=9)                     
----------------------------------------------------------------------------
ACR20                 67%           80%*          56%           17%         
----------------------------------------------------------------------------
ACR50                 33%           50%           56%           0%          
----------------------------------------------------------------------------
ACR70                 22%           10%           44%           0%          
----------------------------------------------------------------------------
DAS28< 2.6            33%           60%*          56%*          0%          
(remission)                                                                 
----------------------------------------------------------------------------

Dr Josefin-Beate Holz, Chief Medical Officer of Ablynx, commented:
"We are extremely pleased with the results from the first 12 weeks of this study. The observed high clinical remission in combination with the very encouraging safety profile demonstrates that ALX-0061 is potentially unique and differentiated compared with monoclonal antibodies that target the IL-6 pathway."

Dr Edwin Moses, Chairman and CEO of Ablynx added:
"We believe that ALX-0061 could become a very valuable alternative treatment option for patients with RA. Efficacy, safety and convenience of administration are key to patients and payers, and ALX-0061 has the potential to offer important advantages in all these areas. We anticipate that these data will generate a lot of interest and trigger a number of pharma companies to initiate partnering discussions. This is our second clinical proof-of-concept for a Nanobody and further emphasizes the potential value of our clinical assets. It also reinforces the power and breadth of our unique technology platform, building on the recent successful first pulmonary delivery of a Nanobody (ALX-0171 in RSV)."

Conference call and webcast presentation
The Ablynx management team will host a conference call and webcast during which the results from this Phase I/II proof-of-concept study will be presented, followed by a Q&A session. This event will be held today, 4 October 2012 at 15h CET/ 9 am EST. The conference call will be webcast live and may be accessed on the home page of the Ablynx website at www.ablynx.com or by clicking here. If you would like to participate in the Q&A, please dial +32 (0)2 620 01 38. Shortly after the call, a replay of the webcast and the presentation used in connection with the conference call webcast will be available on the Company's website.

About ALX-0061 (anti-IL-6R)
ALX-0061 is a 26kD Nanobody that binds to both the soluble and membrane-bound interleukin-6 receptor (IL-6R). ALX-0061 is half-life extended with a Nanobody targeting albumin, which is believed to improve the delivery of the Nanobody to inflamed tissues.

The involvement of the IL-6 pathway in a variety of diseases indicates that multiple indications can be pursued with a large market potential including rheumatoid arthritis (RA), Crohn's disease, Castleman's disease, multiple myeloma and systemic lupus erythematosus (SLE). Blocking the IL-6 pathway is becoming the preferred second line biological treatment. (Ro)Actemra® (Roche) is the only anti-IL-6R biological on the market and its sales are expected to increase to $2.2bn in 2015(5).

Final results from the Phase I/II study at week 24 with ALX-0061 in patients with active RA are expected during the first quarter of 2013.

(1) *p< 0.05 - descriptive statistical analyses
DAS28 is an RA disease activity score based on C-reactive protein (CRP), tender and swollen joint counts of 28 defined joints and physician's global health assessment; a total score of >5.1 is associated with high disease activity, moderate from 3.2 to 5.1, low disease activity from 2.6, and remission of disease if < 2.6
(2) ACR criteria measure improvement in tender or swollen joint counts and improvement in three of five other disease-activity measures; ACR20 measures % of patients with 20% improvement; ACR50 measures % of patients with 50% improvement and ACR70 measures % of patients with 70% improvement
(3) DMARDs: disease modifying anti-rheumatoid arthritis drugs
(4) Three patients withdrew prior to week 12 assessment
(5) MedTrack

About Ablynx
Ablynx is a biopharmaceutical company engaged in the discovery and development of Nanobodies®, a novel class of therapeutic proteins based on single-domain antibody fragments, for a range of serious human diseases, including inflammation, haematology, oncology and pulmonary disease. Today, the Company has approximately 25 programmes in the pipeline and seven Nanobodies at clinical development stage. Ablynx has ongoing research collaborations and significant partnerships with major pharmaceutical companies including Boehringer Ingelheim, Merck KGaA, Novartis and Merck & Co. The Company is headquartered in Ghent, Belgium. More information can be found on www.ablynx.com.

Press release in pdf: http://hugin.info/137912/R/1646263/530500.pdf


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: edwin.moses@ablynx.com

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

M:Communications:
Mary-Jane Elliott, Amber Bielecka, Claire Dickinson
t: +44 207 920 2330
e: ablynx@mcomgroup.com


Read at BioSpace.com


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