News Feed Item

Spinifex Pharmaceuticals' Phase 2 Results Published in The Lancet Show EMA401 to be Effective in Reducing Pain in Postherpetic Neuralgia

MELBOURNE, Australia, February 5, 2014 /PRNewswire/ --

  • Phase 2 trial met its primary endpoint, reduced pain in postherpetic neuralgia (PHN) versus placebo
  • Significant patient response to EMA401 treatment and drop in pain intensity compared with placebo, meeting a key secondary endpoint
  • First published demonstration of the therapeutic potential of angiotensin II type 2 (AT2)receptor antagonists
  • EMA401 identified as a possible new treatment for neuropathic pain with a novel mechanism of action

Spinifex Pharmaceuticals, an Australian pain drug development company, today announces that The Lancet has published the results of its Phase 2 clinical trial of its lead candidate, EMA401, in postherpetic neuralgia (PHN)[1]. EMA401 is a novel angiotensin II type 2 (AT2) receptor antagonist under development as a potential first-in-class oral treatment for chronic pain without CNS side effects. PHN is a painful condition that develops in some patients following herpes zoster (shingles) and where existing therapy does not relieve pain in all individuals.

The Phase 2 trial met its primary endpoint by showing that patients randomised to EMA401 achieved a greater reduction in pain from baseline to the last week of 28 days of treatment than patients randomised to placebo. Analysing all patients randomised (intent to treat population), the mean pain intensity reduction from baseline after 4 weeks treatment was as follows: EMA401: -2.29; Placebo: -1.60; p = 0.007.

A significantly greater proportion of patients on active treatment reported a more than 30% reduction in mean pain intensity score compared to baseline (i.e. responder rate) (EMA401: 57.6%; Placebo: 35.2%; p = 0.0023), meeting a key secondary endpoint.

A subgroup of patients who had moderate or severe pain at study entry continued to take a single existing medicine for their PHN during the study (45% of patients in the EMA401 group and 40% of patients in the placebo group). In this subgroup, patients randomised to EMA401 achieved significantly greater pain reduction when compared to patients randomised to placebo. In addition, pain relief was also observed in those patients that were not taking a single existing medicine for their PHN. These results indicate that EMA401 may have the potential to provide relief for patients with PHN who don't achieve optimal pain relief with current treatments or who don't wish to continue with these medicines due to their side effects.

EMA401 was generally safe and well tolerated with no serious treatment related adverse events reported.

In a commentary also published in the Lancet[2], Dr Nanna Finnerup, of the Danish Pain Research Center, Aarhus University, described this first clinical study to evaluate the efficacy of an AT2 receptor antagonist in neuropathic pain as encouraging adding: "Most importantly, their work identifies a possible new drug for the treatment of neuropathic pain with a novel mechanism of action, and thus offers hope for patients who have insufficient pain relief with presently available drugs."


1. EMA401, an orally administered highly selective angiotensin II type 2 receptor antagonist, as a novel treatment for postherpetic neuralgia: a randomised, double-blind, placebo-controlled phase 2 clinical trial, Rice, A.S.C. et al., The Lancet, Published Online, February 5, 2014; http://dx.doi.org/10.1016/S0140-6736(13)62337   

2. Angiotensin II: from blood pressure to pain control, Finnerup, N. B. et al., The Lancet, Published Online, February 5, 2014; http://dx.doi.org/10.1016/S0140-6736(13)62638-0

Andrew Rice, a Professor of Pain Research at Imperial College, Hon. Consultant in Pain Medicine at Chelsea and Westminster Hospital, and lead author of The Lancet paper said: "These results demonstrated EMA401 was able to significantly reduce pain in patients with postherpetic neuralgia and was well tolerated. This paper is the first publication of the clinical effects of any AT2 receptor antagonist and contributes to our understanding of the potentially important role of this new drug class in relieving chronic pain. These results are an exciting step in the development of a novel approach to the treatment of neuropathic pain and chronic pain more generally."

Spinifex Pharmaceuticals' CEO Tom McCarthy said: "There is a clear need for new treatments that bring patients pain relief with fewer CNS side effects. The publication of the Phase 2 data with EMA401 in such a prestigious publication is an endorsement of the quality of our scientific development capabilities. We are pleased The Lancet, in the associated commentary, recognises the significant milestone we have achieved in translating basic science on a new pain pathway into clinical efficacy in patients. As stated in the commentary, in addition to PHN, we see broad potential for EMA401 to treat a range of chronic painful conditions such as pain due to osteoarthritis and diabetes. We look forward to delivering on the further development of EMA401."

The paper is available via the following link: http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(13)62337/abstract.


EMA401 is an angiotensin II type 2 (AT2) receptor antagonist. The discovery that AT2 receptor antagonists offer an innovative approach to the treatment of neuropathic and inflammatory pain was originally made by Professor Maree Smith at The University of Queensland. Having acquired the technology, Spinifex has conducted a comprehensive pre-clinical and early clinical development program on EMA401. In addition to positive Phase 2 results, EMA401 has shown efficacy in a number of relevant pre-clinical models and good human safety and pharmacokinetics in Phase 1 studies. Spinifex's clinical program for EMA401 includes an ongoing Phase 2 study in the treatment of pain in patients with cancer chemotherapy. Spinifex continues to conduct research into the role of the AT2 receptor in nociceptive, inflammatory and neuropathic pain states and these fundamental studies support not only the EMA401 clinical program but also Spinifex's ongoing AT2 receptor antagonist drug discovery program.

Spinifex Pharmaceuticals

Spinifex Pharmaceuticals is an Australian biotechnology company developing new drug candidates for the treatment and management of pain.

Established in 2005 and based in Melbourne, Spinifex has applied its world-class drug development capabilities to advance product candidates. Its lead product EMA401 is under development as a potential first-in-class oral treatment for chronic pain and related symptoms without CNS side effects. Spinifex's Phase 2 program for EMA401 includes clinical trials in a number of chronic pain conditions. Spinifex investors are GBS Venture Partners, Brandon Capital Partners, Uniseed and UniQuest.


For more information please contact:

Dr Tom McCarthy                    
CEO Spinifex Pharmaceuticals            
Tel: +1-203-321-7130                
Email: [email protected]        

Chris Gardner/Sita Shah
Citigate Dewe Rogerson
Tel: +44(0)20-7638-9571
Email: [email protected]

More Stories By PR Newswire

Copyright © 2007 PR Newswire. All rights reserved. Republication or redistribution of PRNewswire content is expressly prohibited without the prior written consent of PRNewswire. PRNewswire shall not be liable for any errors or delays in the content, or for any actions taken in reliance thereon.

Latest Stories
@ThingsExpo has been named the Top 5 Most Influential M2M Brand by Onalytica in the ‘Machine to Machine: Top 100 Influencers and Brands.' Onalytica analyzed the online debate on M2M by looking at over 85,000 tweets to provide the most influential individuals and brands that drive the discussion. According to Onalytica the "analysis showed a very engaged community with a lot of interactive tweets. The M2M discussion seems to be more fragmented and driven by some of the major brands present in the...
SYS-CON Events announced today that Interface Masters Technologies, a leader in Network Visibility and Uptime Solutions, will exhibit at the 19th International Cloud Expo, which will take place on November 1–3, 2016, at the Santa Clara Convention Center in Santa Clara, CA. Interface Masters Technologies is a leading vendor in the network monitoring and high speed networking markets. Based in the heart of Silicon Valley, Interface Masters' expertise lies in Gigabit, 10 Gigabit and 40 Gigabit Eth...
As software becomes more and more complex, we, as software developers, have been splitting up our code into smaller and smaller components. This is also true for the environment in which we run our code: going from bare metal, to VMs to the modern-day Cloud Native world of containers, schedulers and microservices. While we have figured out how to run containerized applications in the cloud using schedulers, we've yet to come up with a good solution to bridge the gap between getting your conta...
We are reaching the end of the beginning with WebRTC, and real systems using this technology have begun to appear. One challenge that faces every WebRTC deployment (in some form or another) is identity management. For example, if you have an existing service – possibly built on a variety of different PaaS/SaaS offerings – and you want to add real-time communications you are faced with a challenge relating to user management, authentication, authorization, and validation. Service providers will w...
DevOps is being widely accepted (if not fully adopted) as essential in enterprise IT. But as Enterprise DevOps gains maturity, expands scope, and increases velocity, the need for data-driven decisions across teams becomes more acute. DevOps teams in any modern business must wrangle the ‘digital exhaust’ from the delivery toolchain, "pervasive" and "cognitive" computing, APIs and services, mobile devices and applications, the Internet of Things, and now even blockchain. In this power panel at @...
DevOps theory promotes a culture of continuous improvement built on collaboration, empowerment, systems thinking, and feedback loops. But how do you collaborate effectively across the traditional silos? How can you make decisions without system-wide visibility? How can you see the whole system when it is spread across teams and locations? How do you close feedback loops across teams and activities delivering complex multi-tier, cloud, container, serverless, and/or API-based services?
SYS-CON Media announced today that @WebRTCSummit Blog, the largest WebRTC resource in the world, has been launched. @WebRTCSummit Blog offers top articles, news stories, and blog posts from the world's well-known experts and guarantees better exposure for its authors than any other publication. @WebRTCSummit Blog can be bookmarked ▸ Here @WebRTCSummit conference site can be bookmarked ▸ Here
SYS-CON Events announced today that Streamlyzer will exhibit at the 19th International Cloud Expo, which will take place on November 1–3, 2016, at the Santa Clara Convention Center in Santa Clara, CA. Streamlyzer is a powerful analytics for video streaming service that enables video streaming providers to monitor and analyze QoE (Quality-of-Experience) from end-user devices in real time.
You have great SaaS business app ideas. You want to turn your idea quickly into a functional and engaging proof of concept. You need to be able to modify it to meet customers' needs, and you need to deliver a complete and secure SaaS application. How could you achieve all the above and yet avoid unforeseen IT requirements that add unnecessary cost and complexity? You also want your app to be responsive in any device at any time. In his session at 19th Cloud Expo, Mark Allen, General Manager of...
One of biggest questions about Big Data is “How do we harness all that information for business use quickly and effectively?” Geographic Information Systems (GIS) or spatial technology is about more than making maps, but adding critical context and meaning to data of all types, coming from all different channels – even sensors. In his session at @ThingsExpo, William (Bill) Meehan, director of utility solutions for Esri, will take a closer look at the current state of spatial technology and ar...
SYS-CON Events announced today that SoftNet Solutions will exhibit at the 19th International Cloud Expo, which will take place on November 1–3, 2016, at the Santa Clara Convention Center in Santa Clara, CA. SoftNet Solutions specializes in Enterprise Solutions for Hadoop and Big Data. It offers customers the most open, robust, and value-conscious portfolio of solutions, services, and tools for the shortest route to success with Big Data. The unique differentiator is the ability to architect and ...
The IoT industry is now at a crossroads, between the fast-paced innovation of technologies and the pending mass adoption by global enterprises. The complexity of combining rapidly evolving technologies and the need to establish practices for market acceleration pose a strong challenge to global enterprises as well as IoT vendors. In his session at @ThingsExpo, Clark Smith, senior product manager for Numerex, will discuss how Numerex, as an experienced, established IoT provider, has embraced a ...
Without lifecycle traceability and visibility across the tool chain, stakeholders from Planning-to-Ops have limited insight and answers to who, what, when, why and how across the DevOps lifecycle. This impacts the ability to deliver high quality software at the needed velocity to drive positive business outcomes. In his session at @DevOpsSummit 19th Cloud Expo, Eric Robertson, General Manager at CollabNet, will show how customers are able to achieve a level of transparency that enables everyon...
Today every business relies on software to drive the innovation necessary for a competitive edge in the Application Economy. This is why collaboration between development and operations, or DevOps, has become IT’s number one priority. Whether you are in Dev or Ops, understanding how to implement a DevOps strategy can deliver faster development cycles, improved software quality, reduced deployment times and overall better experiences for your customers.
Cloud based infrastructure deployment is becoming more and more appealing to customers, from Fortune 500 companies to SMEs due to its pay-as-you-go model. Enterprise storage vendors are able to reach out to these customers by integrating in cloud based deployments; this needs adaptability and interoperability of the products confirming to cloud standards such as OpenStack, CloudStack, or Azure. As compared to off the shelf commodity storage, enterprise storages by its reliability, high-availabil...