Welcome!

Agile Computing Authors: Carmen Gonzalez, Yeshim Deniz, Liz McMillan, Elizabeth White, Janakiram MSV

News Feed Item

Ablynx's Anti-IL-6R Nanobody, ALX-0061, Shows Excellent 24 Week Safety and Efficacy Results in a Phase II Clinical Trial in Rheumatoid Arthritis

GHENT, BELGIUM -- (Marketwire) -- 02/13/13 -- Ablynx (EURONEXT BRUSSELS: ABLX)

  • ACR20, ACR50 and ACR70 scores of up to 100%, 75% and 63% respectively
  • Up to 75% of patients in DAS28 remission
  • Attractive safety profile at all administered doses
  • No anti-drug antibodies detected
  • No disease progression as determined by MRI radiography

Results will be discussed during a webcast presentation today at 16h CET, 10 am EST
Click here to register, call number +32 (0)2 620 01 38

Ablynx (EURONEXT BRUSSELS: ABLX) today announced efficacy and safety data for its anti-IL-6R Nanobody, ALX-0061, at the 24 week final analysis of the Phase II part of a combined Phase I/II study in patients with moderately to severely active rheumatoid arthritis (RA) on a stable background of methotrexate.

In this Phase II part, 37 RA patients were recruited and were randomised to three dose groups of intravenously administered ALX-0061 (1mg/kg Q4W[1], 3mg/kg Q4W and 6mg/kg Q8W1) or to placebo. A total of 34 patients were eligible for determination of efficacy parameters at the 12 week interim period, and all these patients continued the study until week 24.

Depending on the patient's disease status at week 10, the monthly dose was increased (from 1mg/kg to 3mg/kg; or from 3mg/kg to 6mg/kg) or the dosing regimen intensified (from 6mg/kg Q8W to 6 mg/kg Q4W), and patients on placebo could start monthly ALX-0061 treatment at 3mg/kg. The vast majority of patients (86%, N=24) completed the study at their ALX-0061 starting regimen (the 'unmodified' group), for 4 patients the dosing regimen was modified (the 'modified' group) and 3 patients were switched from placebo to ALX-0061 treatment (the 'switchers').

At all doses tested, ALX-0061 was well-tolerated and the safety profile compared favourably to data reported for other biological DMARDs[2]. No clinically relevant neutropenia (moderate or severe decrease in neutrophils, a type of white blood cell), no clinically significant increases in lipid levels (cholesterol and triglycerides) were observed, and there were no serious infections. Infrequent elevation of liver enzymes were reported; the events were transient, generally mild to moderate, and did not result in a discontinuation of the treatment. Additionally, the side effect profile of ALX-0061 did not change with increased dose or treatment duration and no anti-drug antibodies were detected.

The efficacy results for the 'unmodified' patient population at week 24 are presented below:

----------------------------------------------------------------------------
Efficacy parameter   1mg/kg Q4W  3mg/kg Q4W  6mg/kg Q8W  Pooled 'unmodified'
                     (N=8)       (N=8)       (N=8)       (N=24)
----------------------------------------------------------------------------
ACR20[3]             75%         100%        75%         83%
----------------------------------------------------------------------------
ACR50                63%         75%         75%         71%
----------------------------------------------------------------------------
ACR70                50%         63%         63%         58%
----------------------------------------------------------------------------
DAS28 remission[4]   50%         75%         63%         63%
----------------------------------------------------------------------------
Boolean              25%         38%         25%         29%
remission[5]
----------------------------------------------------------------------------

The efficacy results at week 24 for the 'modified' patient population and patients switching from placebo to ALX-0061 treatment are presented below:

---------------------------------------------------------------
Efficacy parameter    Pooled 'modified'    Pooled 'switchers'
                      (N=4)                (N=3)
---------------------------------------------------------------
ACR20                 75%                  100%
---------------------------------------------------------------
ACR50                 50%                  67%
---------------------------------------------------------------
ACR70                 50%                  0%
---------------------------------------------------------------
DAS28 remission       50%                  33%
---------------------------------------------------------------

A magnetic resonance imaging (MRI) assessment was also included in this study. At week 24, there was a reduction of bone oedema, which is an early indicator of joint destruction. Additionally, the global radiographic score confirmed the absence of disease progression at this final time point.

Dr Josefin-Beate Holz, Chief Medical Officer of Ablynx, commented:
"We are very pleased with the 24 week results of this Phase II part of the study. We believe we have shown impressive clinical activity for ALX-0061 at the predicted dose levels as well as the potential for dosing every four or every eight weeks. The side effect profile of the Nanobody did not change over time or with dose escalation and the therapeutic effect improved even further with treatment duration. The majority of patients achieved a durable status of disease remission, some of them already after the first month of treatment. In addition, patients who had an inadequate response could be identified early on in the treatment schedule and could even be 'rescued'. These findings confirm the potential for ALX-0061 and the drug could become an important addition to clinicians' range of tools to treat this severely debilitating disease."

Dr Edwin Moses, Chairman and CEO of Ablynx added:
"We believe that these new data provide additional confidence that ALX-0061 could become a very valuable treatment option for patients with RA. We are now investigating the various possibilities through which we can progress the development of ALX-0061, including discussions with potential partners and other paths which will allow us to maximise the value of this asset."

Conference call and webcast presentation
The Ablynx management team will host a conference call and webcast during which the Phase II results at week 24 will be presented, followed by a Q&A session. This event will be held today, 13 February 2013 at 4.00 pm CET/ 10 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 0138. 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 targets the interleukin 6 pathway via its IL-6receptor (IL-6R), which plays a fundamental role in the inflammation process in RA.

ALX-0061 has been designed to become a best-in-class therapeutic. Its small size (26kD) should allow ALX-0061 to penetrate more effectively into tissues. The potent, monovalent interaction of the molecule with its target reduces the possibility of off-target effects. Its binding to human serum albumin prolongs the in vivo half-life of the product and can lead to improved trafficking to areas of inflammation. The Nanobody has a very strong affinity for soluble IL-6R which should ensure fast target engagement and could result in a fast onset of effect. ALX-0061 appears to benefit from the general Nanobody characteristic of having a very low immunogenic potential. ALX-0061 is a very robust and stable drug product that is already manufactured at a multi-thousand litre scale. It can be administered both intravenously and subcutaneously.

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 five Nanobodies at clinical development stage. Ablynx has ongoing research collaborations and significant partnerships with major pharmaceutical companies including Boehringer Ingelheim, Merck Serono, Novartis and Merck & Co. The Company is headquartered in Ghent, Belgium. More information can be found on www.ablynx.com.

[1] Q4W: every 4 weeks - Q8W: every 8 weeks
[2] DMARDs: disease modifying anti-rheumatoid arthritis drugs
[3] ACR (American College of Rheumatology) 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
[4] 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 3.2 to 2.6, and remission of disease if < 2.6
[5] Boolean remission in RA is a more recent measure of disease activity and is achieved when at any time point, a patient satisfies all of the following: swollen and tender joint count, patient global assessment and CRP all less than or equal to 1.

press release in pdf format: http://hugin.info/137912/R/1677523/547097.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: [email protected]

Marieke Vermeersch
Associate Director Investor Relations
t: +32 (0)9 262 00 82
m: +32 (0)479 49 06 03
e: [email protected]
Follow us on Twitter @AblynxABLX

M:Communications:
Mary-Jane Elliott, Amber Bielecka, Claire Dickinson
t: +44 207 920 2330
e: [email protected]

More Stories By Marketwired .

Copyright © 2009 Marketwired. All rights reserved. All the news releases provided by Marketwired are copyrighted. Any forms of copying other than an individual user's personal reference without express written permission is prohibited. Further distribution of these materials is strictly forbidden, including but not limited to, posting, emailing, faxing, archiving in a public database, redistributing via a computer network or in a printed form.

@ThingsExpo Stories
Bert Loomis was a visionary. This general session will highlight how Bert Loomis and people like him inspire us to build great things with small inventions. In their general session at 19th Cloud Expo, Harold Hannon, Architect at IBM Bluemix, and Michael O'Neill, Strategic Business Development at Nvidia, discussed the accelerating pace of AI development and how IBM Cloud and NVIDIA are partnering to bring AI capabilities to "every day," on-demand. They also reviewed two "free infrastructure" pr...
The 20th International Cloud Expo has announced that its Call for Papers is open. Cloud Expo, to be held June 6-8, 2017, at the Javits Center in New York City, brings together Cloud Computing, Big Data, Internet of Things, DevOps, Containers, Microservices and WebRTC to one location. With cloud computing driving a higher percentage of enterprise IT budgets every year, it becomes increasingly important to plant your flag in this fast-expanding business opportunity. Submit your speaking proposal ...
New competitors, disruptive technologies, and growing expectations are pushing every business to both adopt and deliver new digital services. This ‘Digital Transformation’ demands rapid delivery and continuous iteration of new competitive services via multiple channels, which in turn demands new service delivery techniques – including DevOps. In this power panel at @DevOpsSummit 20th Cloud Expo, moderated by DevOps Conference Co-Chair Andi Mann, panelists will examine how DevOps helps to meet th...
NHK, Japan Broadcasting, will feature the upcoming @ThingsExpo Silicon Valley in a special 'Internet of Things' and smart technology documentary that will be filmed on the expo floor between November 3 to 5, 2015, in Santa Clara. NHK is the sole public TV network in Japan equivalent to the BBC in the UK and the largest in Asia with many award-winning science and technology programs. Japanese TV is producing a documentary about IoT and Smart technology and will be covering @ThingsExpo Silicon Val...
Five years ago development was seen as a dead-end career, now it’s anything but – with an explosion in mobile and IoT initiatives increasing the demand for skilled engineers. But apart from having a ready supply of great coders, what constitutes true ‘DevOps Royalty’? It’ll be the ability to craft resilient architectures, supportability, security everywhere across the software lifecycle. In his keynote at @DevOpsSummit at 20th Cloud Expo, Jeffrey Scheaffer, GM and SVP, Continuous Delivery Busine...
SYS-CON Events announced today that Hitachi, the leading provider the Internet of Things and Digital Transformation, will exhibit at SYS-CON's 20th International Cloud Expo®, which will take place on June 6-8, 2017, at the Javits Center in New York City, NY. Hitachi Data Systems, a wholly owned subsidiary of Hitachi, Ltd., offers an integrated portfolio of services and solutions that enable digital transformation through enhanced data management, governance, mobility and analytics. We help globa...
SYS-CON Events announced today that T-Mobile will exhibit at SYS-CON's 20th International Cloud Expo®, which will take place on June 6-8, 2017, at the Javits Center in New York City, NY. As America's Un-carrier, T-Mobile US, Inc., is redefining the way consumers and businesses buy wireless services through leading product and service innovation. The Company's advanced nationwide 4G LTE network delivers outstanding wireless experiences to 67.4 million customers who are unwilling to compromise on ...
With major technology companies and startups seriously embracing IoT strategies, now is the perfect time to attend @ThingsExpo 2016 in New York. Learn what is going on, contribute to the discussions, and ensure that your enterprise is as "IoT-Ready" as it can be! Internet of @ThingsExpo, taking place June 6-8, 2017, at the Javits Center in New York City, New York, is co-located with 20th Cloud Expo and will feature technical sessions from a rock star conference faculty and the leading industry p...
NHK, Japan Broadcasting, will feature the upcoming @ThingsExpo Silicon Valley in a special 'Internet of Things' and smart technology documentary that will be filmed on the expo floor between November 3 to 5, 2015, in Santa Clara. NHK is the sole public TV network in Japan equivalent to the BBC in the UK and the largest in Asia with many award-winning science and technology programs. Japanese TV is producing a documentary about IoT and Smart technology and will be covering @ThingsExpo Silicon Val...
20th Cloud Expo, taking place June 6-8, 2017, at the Javits Center in New York City, NY, will feature technical sessions from a rock star conference faculty and the leading industry players in the world. Cloud computing is now being embraced by a majority of enterprises of all sizes. Yesterday's debate about public vs. private has transformed into the reality of hybrid cloud: a recent survey shows that 74% of enterprises have a hybrid cloud strategy.
SYS-CON Events announced today that SoftLayer, an IBM Company, has been named “Gold Sponsor” of SYS-CON's 18th Cloud Expo, which will take place on June 7-9, 2016, at the Javits Center in New York, New York. SoftLayer, an IBM Company, provides cloud infrastructure as a service from a growing number of data centers and network points of presence around the world. SoftLayer’s customers range from Web startups to global enterprises.
With major technology companies and startups seriously embracing Cloud strategies, now is the perfect time to attend @CloudExpo | @ThingsExpo, June 6-8, 2017, at the Javits Center in New York City, NY and October 31 - November 2, 2017, Santa Clara Convention Center, CA. Learn what is going on, contribute to the discussions, and ensure that your enterprise is on the right path to Digital Transformation.
Most technology leaders, contemporary and from the hardware era, are reshaping their businesses to do software in the hope of capturing value in IoT. Although IoT is relatively new in the market, it has already gone through many promotional terms such as IoE, IoX, SDX, Edge/Fog, Mist Compute, etc. Ultimately, irrespective of the name, it is about deriving value from independent software assets participating in an ecosystem as one comprehensive solution.
SYS-CON Events announced today that Hitachi Data Systems, a wholly owned subsidiary of Hitachi LTD., will exhibit at SYS-CON's 20th International Cloud Expo®, which will take place on June 6-8, 2017, at the Javits Center in New York City. Hitachi Data Systems (HDS) will be featuring the Hitachi Content Platform (HCP) portfolio. This is the industry’s only offering that allows organizations to bring together object storage, file sync and share, cloud storage gateways, and sophisticated search an...
SYS-CON Events announced today that Hitachi, the leading provider the Internet of Things and Digital Transformation, will exhibit at SYS-CON's 20th International Cloud Expo®, which will take place on June 6-8, 2017, at the Javits Center in New York City, NY. Hitachi Data Systems, a wholly owned subsidiary of Hitachi, Ltd., offers an integrated portfolio of services and solutions that enable digital transformation through enhanced data management, governance, mobility and analytics. We help globa...
DevOps is often described as a combination of technology and culture. Without both, DevOps isn't complete. However, applying the culture to outdated technology is a recipe for disaster; as response times grow and connections between teams are delayed by technology, the culture will die. A Nutanix Enterprise Cloud has many benefits that provide the needed base for a true DevOps paradigm.
SYS-CON Events announced today that CollabNet, a global leader in enterprise software development, release automation and DevOps solutions, will be a Bronze Sponsor of SYS-CON's 20th International Cloud Expo®, taking place from June 6-8, 2017, at the Javits Center in New York City, NY. CollabNet offers a broad range of solutions with the mission of helping modern organizations deliver quality software at speed. The company’s latest innovation, the DevOps Lifecycle Manager (DLM), supports Value S...
SYS-CON Events announced today that Super Micro Computer, Inc., a global leader in compute, storage and networking technologies, will exhibit at SYS-CON's 20th International Cloud Expo®, which will take place on June 6-8, 2017, at the Javits Center in New York City, NY. Supermicro (NASDAQ: SMCI), the leading innovator in high-performance, high-efficiency server technology, is a premier provider of advanced server Building Block Solutions® for Data Center, Cloud Computing, Enterprise IT, Hadoop/...
Amazon has gradually rolled out parts of its IoT offerings in the last year, but these are just the tip of the iceberg. In addition to optimizing their back-end AWS offerings, Amazon is laying the ground work to be a major force in IoT – especially in the connected home and office. Amazon is extending its reach by building on its dominant Cloud IoT platform, its Dash Button strategy, recently announced Replenishment Services, the Echo/Alexa voice recognition control platform, the 6-7 strategic...
SYS-CON Events announced today that Juniper Networks (NYSE: JNPR), an industry leader in automated, scalable and secure networks, will exhibit at SYS-CON's 20th International Cloud Expo®, which will take place on June 6-8, 2017, at the Javits Center in New York City, NY. Juniper Networks challenges the status quo with products, solutions and services that transform the economics of networking. The company co-innovates with customers and partners to deliver automated, scalable and secure network...