Click here to close now.


Agile Computing Authors: Victoria Livschitz, Liz McMillan, Ian Khan, Pat Romanski, Elizabeth White

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%

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 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

[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:

For more information, please contact
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

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
The broad selection of hardware, the rapid evolution of operating systems and the time-to-market for mobile apps has been so rapid that new challenges for developers and engineers arise every day. Security, testing, hosting, and other metrics have to be considered through the process. In his session at Big Data Expo, Walter Maguire, Chief Field Technologist, HP Big Data Group, at Hewlett-Packard, will discuss the challenges faced by developers and a composite Big Data applications builder, focusing on how to help solve the problems that developers are continuously battling.
As enterprises capture more and more data of all types – structured, semi-structured, and unstructured – data discovery requirements for business intelligence (BI), Big Data, and predictive analytics initiatives grow more complex. A company’s ability to become data-driven and compete on analytics depends on the speed with which it can provision their analytics applications with all relevant information. The task of finding data has traditionally resided with IT, but now organizations increasingly turn towards data source discovery tools to find the right data, in context, for business users, d...
SYS-CON Events announced today that MobiDev, a software development company, will exhibit at the 17th International Cloud Expo®, which will take place November 3-5, 2015, at the Santa Clara Convention Center in Santa Clara, CA. MobiDev is a software development company with representative offices in Atlanta (US), Sheffield (UK) and Würzburg (Germany); and development centers in Ukraine. Since 2009 it has grown from a small group of passionate engineers and business managers to a full-scale mobile software company with over 150 developers, designers, quality assurance engineers, project manage...
Organizations already struggle with the simple collection of data resulting from the proliferation of IoT, lacking the right infrastructure to manage it. They can't only rely on the cloud to collect and utilize this data because many applications still require dedicated infrastructure for security, redundancy, performance, etc. In his session at 17th Cloud Expo, Emil Sayegh, CEO of Codero Hosting, will discuss how in order to resolve the inherent issues, companies need to combine dedicated and cloud solutions through hybrid hosting – a sustainable solution for the data required to manage I...
Clearly the way forward is to move to cloud be it bare metal, VMs or containers. One aspect of the current public clouds that is slowing this cloud migration is cloud lock-in. Every cloud vendor is trying to make it very difficult to move out once a customer has chosen their cloud. In his session at 17th Cloud Expo, Naveen Nimmu, CEO of Clouber, Inc., will advocate that making the inter-cloud migration as simple as changing airlines would help the entire industry to quickly adopt the cloud without worrying about any lock-in fears. In fact by having standard APIs for IaaS would help PaaS expl...
Apps and devices shouldn't stop working when there's limited or no network connectivity. Learn how to bring data stored in a cloud database to the edge of the network (and back again) whenever an Internet connection is available. In his session at 17th Cloud Expo, Bradley Holt, Developer Advocate at IBM Cloud Data Services, will demonstrate techniques for replicating cloud databases with devices in order to build offline-first mobile or Internet of Things (IoT) apps that can provide a better, faster user experience, both offline and online. The focus of this talk will be on IBM Cloudant, Apa...
SYS-CON Events announced today that Cloud Raxak has been named “Media & Session Sponsor” of SYS-CON's 17th Cloud Expo, which will take place on November 3–5, 2015, at the Santa Clara Convention Center in Santa Clara, CA. Raxak Protect automates security compliance across private and public clouds. Using the SaaS tool or managed service, developers can deploy cloud apps quickly, cost-effectively, and without error.
SYS-CON Events announced today that ProfitBricks, the provider of painless cloud infrastructure, will exhibit at SYS-CON's 17th International Cloud Expo®, which will take place on November 3–5, 2015, at the Santa Clara Convention Center in Santa Clara, CA. ProfitBricks is the IaaS provider that offers a painless cloud experience for all IT users, with no learning curve. ProfitBricks boasts flexible cloud servers and networking, an integrated Data Center Designer tool for visual control over the cloud and the best price/performance value available. ProfitBricks was named one of the coolest Clo...
Mobile messaging has been a popular communication channel for more than 20 years. Finnish engineer Matti Makkonen invented the idea for SMS (Short Message Service) in 1984, making his vision a reality on December 3, 1992 by sending the first message ("Happy Christmas") from a PC to a cell phone. Since then, the technology has evolved immensely, from both a technology standpoint, and in our everyday uses for it. Originally used for person-to-person (P2P) communication, i.e., Sally sends a text message to Betty – mobile messaging now offers tremendous value to businesses for customer and empl...
SYS-CON Events announced today that IBM Cloud Data Services has been named “Bronze Sponsor” of SYS-CON's 17th Cloud Expo, which will take place on November 3–5, 2015, at the Santa Clara Convention Center in Santa Clara, CA. IBM Cloud Data Services offers a portfolio of integrated, best-of-breed cloud data services for developers focused on mobile computing and analytics use cases.
Learn how IoT, cloud, social networks and last but not least, humans, can be integrated into a seamless integration of cooperative organisms both cybernetic and biological. This has been enabled by recent advances in IoT device capabilities, messaging frameworks, presence and collaboration services, where devices can share information and make independent and human assisted decisions based upon social status from other entities. In his session at @ThingsExpo, Michael Heydt, founder of Seamless Thingies, will discuss and demonstrate how devices and humans can be integrated from a simple clust...
Who are you? How do you introduce yourself? Do you use a name, or do you greet a friend by the last four digits of his social security number? Assuming you don’t, why are we content to associate our identity with 10 random digits assigned by our phone company? Identity is an issue that affects everyone, but as individuals we don’t spend a lot of time thinking about it. In his session at @ThingsExpo, Ben Klang, Founder & President of Mojo Lingo, will discuss the impact of technology on identity. Should we federate, or not? How should identity be secured? Who owns the identity? How is identity ...
You have your devices and your data, but what about the rest of your Internet of Things story? Two popular classes of technologies that nicely handle the Big Data analytics for Internet of Things are Apache Hadoop and NoSQL. Hadoop is designed for parallelizing analytical work across many servers and is ideal for the massive data volumes you create with IoT devices. NoSQL databases such as Apache HBase are ideal for storing and retrieving IoT data as “time series data.”
SYS-CON Events announced today that HPM Networks will exhibit at the 17th International Cloud Expo®, which will take place on November 3–5, 2015, at the Santa Clara Convention Center in Santa Clara, CA. For 20 years, HPM Networks has been integrating technology solutions that solve complex business challenges. HPM Networks has designed solutions for both SMB and enterprise customers throughout the San Francisco Bay Area.
“The Internet of Things transforms the way organizations leverage machine data and gain insights from it,” noted Splunk’s CTO Snehal Antani, as Splunk announced accelerated momentum in Industrial Data and the IoT. The trend is driven by Splunk’s continued investment in its products and partner ecosystem as well as the creativity of customers and the flexibility to deploy Splunk IoT solutions as software, cloud services or in a hybrid environment. Customers are using Splunk® solutions to collect and correlate data from control systems, sensors, mobile devices and IT systems for a variety of Ind...
SYS-CON Events announced today that Solgeniakhela will exhibit at SYS-CON's 17th International Cloud Expo®, which will take place on November 3–5, 2015, at the Santa Clara Convention Center in Santa Clara, CA. Solgeniakhela is the global market leader in Cloud Collaboration and Cloud Infrastructure software solutions. Designed to “Bridge the Gap” between Personal and Professional Social, Mobile and Cloud user experiences, our solutions help large and medium-sized organizations dramatically improve productivity, reduce collaboration costs, and increase the overall enterprise value by bringing ...
Sensors and effectors of IoT are solving problems in new ways, but small businesses have been slow to join the quantified world. They’ll need information from IoT using applications as varied as the businesses themselves. In his session at @ThingsExpo, Roger Meike, Distinguished Engineer, Director of Technology Innovation at Intuit, will show how IoT manufacturers can use open standards, public APIs and custom apps to enable the Quantified Small Business. He will use a Raspberry Pi to connect sensors to web services, and cloud integration to connect accounting and data, providing a Bluetooth...
SYS-CON Events announced today that Micron Technology, Inc., a global leader in advanced semiconductor systems, will exhibit at the 17th International Cloud Expo®, which will take place on November 3–5, 2015, at the Santa Clara Convention Center in Santa Clara, CA. Micron’s broad portfolio of high-performance memory technologies – including DRAM, NAND and NOR Flash – is the basis for solid state drives, modules, multichip packages and other system solutions. Backed by more than 35 years of technology leadership, Micron's memory solutions enable the world's most innovative computing, consumer,...
Nowadays, a large number of sensors and devices are connected to the network. Leading-edge IoT technologies integrate various types of sensor data to create a new value for several business decision scenarios. The transparent cloud is a model of a new IoT emergence service platform. Many service providers store and access various types of sensor data in order to create and find out new business values by integrating such data.
SYS-CON Media announced that Splunk, a provider of the leading software platform for real-time Operational Intelligence, has launched an ad campaign on Big Data Journal. Splunk software and cloud services enable organizations to search, monitor, analyze and visualize machine-generated big data coming from websites, applications, servers, networks, sensors and mobile devices. The ads focus on delivering ROI - how improved uptime delivered $6M in annual ROI, improving customer operations by mining large volumes of unstructured data, and how data tracking delivers uptime when it matters most.