Welcome!

News Feed Item

Amakem Initiates Phase 2a Proof of Concept Study with the Rho Kinase (ROCK) Inhibitor AMA0076 in Patients with Glaucoma and Ocular Hypertension under a US IND

DIEPENBEEK, Belgium, September 27, 2012 /PRNewswire/ --

Amakem NV, a kinase platform company focusing on ophthalmology, today announces that it has initiated a Phase 2a proof of concept study of its novel Rho Kinase (ROCK) inhibitor, AMA0076, in patients with glaucoma and ocular hypertension. The start of the study follows Amakem's receipt of Investigational New Drug Application (IND) approval from the United States Food and Drug Administration (FDA). AMA0076 is a highly potent ROCK inhibitor and is based on Amakem's 'Localized Drug Action' platform, which generates novel kinase inhibitors that minimize the risk of systemic as well as local side effects such as hyperemia.

The study is a multicenter, randomized, double-masked, placebo-controlled dose-escalation study with AMA0076 applied topically, as eye drops. First patients have initiated treatment in this 80 patient clinical trial with six participating centers in the United States (ClinicalTrials.gov identifier NCT01693315).

The primary efficacy endpoint will be reduction in intraocular pressure (IOP), which is a major factor in the pathology of glaucoma, after two and four weeks of dosing. A number of secondary efficacy endpoints will be used to further analyze the impact of AMA0076 on IOP. The Company expects to report top line results in 2013.

AMA0076 is aimed at providing better patient outcomes than other ROCK inhibitor based treatments currently in development because its improved side effect profile enables higher dosing, leading to better efficacy. Pre-clinical studies have shown that AMA0076 highly effectively lowers IOP in relevant models, with a magnitude of IOP reduction exceeding that of the current leading glaucoma treatment latanoprost. Importantly, AMA0076 has been shown to avoid hyperemia, also known as 'red eye', which is seen as a major dose limiting side effect for other ROCK inhibitors in development.

Dr Jack Elands, CEO of Amakem, said: "Today's announcement is a major milestone for Amakem. With our first product entering the clinic we expect to validate our Localized Drug Action platform. Conceived and developed by the company's founder and CSO, Dr Dirk Leysen, this platform allows the development of novel drugs in ophthalmology and other indications, by harnessing the power of kinase inhibition while managing potential side effects. It is very satisfying to have progressed AMA0076 within 20 months from discovery into its first clinical trial and to the point where we believe we will further demonstrate the potential of our platform to create valuable new therapeutics."

Dr Steve Pakola, Chief Medical Officer of Amakem, said: "Glaucoma affects many millions of people and remains a significant cause of vision loss and blindness. Existing treatments are not effective for all patients and while the potential of ROCK inhibitors to reduce IOP has been recognized, their development has been held back by their side effect profile, particularly hyperemia which is distressing for patients and reduces compliance. We look forward to confirming in the clinic the highly promising results we have seen so far with AMA0076 and to advancing what we believe has the potential to be a valuable new treatment option for glaucoma patients."

About Amakem

Amakem is an ophthalmology company developing new treatments for serious eye conditions. Amakem's product pipeline is based on its unique Localized Drug Action platform which is designed to generate safe and effective novel kinase inhibitors that minimize systemic exposure with the aim of reducing side effects. Amakem's lead candidate, AMA0076, is for glaucoma and the Company is working to apply the Localized Drug Action approach to a range of other eye diseases. AMA0076 is currently undergoing Phase 2a proof of concept trials.

Founded in 2010, Amakem has raised more than €21m in funding and is backed by leading life sciences investors including Forbion, Crédit Agricole, Vesalius BioCapital, LRM, PMV/Vinnof and Life Science Research Partners.

Amakem is based in Belgium and located in the life sciences incubator "BioVille" at the University of Hasselt. The Company has a long-standing collaboration with the Ophthalmology Research Center of the University Leuven Hospital.

About Localized Drug Action

Amakem's 'Localized Drug Action' platform is designed to generate novel kinase inhibitor drugs which are contained locally and thus reduce or eliminate side effects. Kinases are crucial mediators of important disease pathways representing more than 22% of the drugable genome. However, kinases are present throughout the body and so there is a significant risk of toxicity due to on target effects in non-target organs and tissues if there is systemic exposure. This risk is acceptable in oncology indications, but not in others thus substantially reducing the potential of drugs targeting this class.

Amakem's kinase inhibitors are designed to be rapidly inactivated outside the target organ. In indications that can be treated by topical administration, it is therefore possible to contain the drug locally as it becomes inactive before it can reach other organs or tissues if it leaks out of the target organ.

Localized Drug Action is based on the inactivation of kinase inhibitors outside the target organ, e.g. in the bloodstream by specifically targeted enzymes. Each of Amakem's kinase inhibitors brings together kinase specificity and enzymatic conversion specificity. When the drug candidate leaves the target organ it is converted to a functionally inactive metabolite. This inactive metabolite is then eliminated from the body.

For more information, please contact

Amakem NV
Jack Elands, CEO
[email protected]
+32(0)474-828-580

Citigate Dewe Rogerson
Chris Gardner/Nina Enegren
[email protected]
[email protected]
+44(0)20-7638-9571

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
Today most companies are adopting or evaluating container technology - Docker in particular - to speed up application deployment, drive down cost, ease management and make application delivery more flexible overall. As with most new architectures, this dream takes significant work to become a reality. Even when you do get your application componentized enough and packaged properly, there are still challenges for DevOps teams to making the shift to continuous delivery and achieving that reducti...
SYS-CON Events announced today that Daiya Industry will exhibit at the Japan External Trade Organization (JETRO) Pavilion at SYS-CON's 21st International Cloud Expo®, which will take place on Oct 31 – Nov 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA. Daiya Industry specializes in orthotic support systems and assistive devices with pneumatic artificial muscles in order to contribute to an extended healthy life expectancy. For more information, please visit https://www.daiyak...
SYS-CON Events announced today that Nihon Micron will exhibit at the Japan External Trade Organization (JETRO) Pavilion at SYS-CON's 21st International Cloud Expo®, which will take place on Oct 31 – Nov 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA. Nihon Micron Co., Ltd. strives for technological innovation to establish high-density, high-precision processing technology for providing printed circuit board and metal mount RFID tags used for communication devices. For more inf...
SYS-CON Events announced today that Massive Networks, that helps your business operate seamlessly with fast, reliable, and secure internet and network solutions, has been named "Exhibitor" of SYS-CON's 21st International Cloud Expo ®, which will take place on Oct 31 - Nov 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA. As a premier telecommunications provider, Massive Networks is headquartered out of Louisville, Colorado. With years of experience under their belt, their team of...
SYS-CON Events announced today that Suzuki Inc. will exhibit at the Japan External Trade Organization (JETRO) Pavilion at SYS-CON's 21st International Cloud Expo®, which will take place on Oct 31 – Nov 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA. Suzuki Inc. is a semiconductor-related business, including sales of consuming parts, parts repair, and maintenance for semiconductor manufacturing machines, etc. It is also a health care business providing experimental research for...
"Our strategy is to focus on the hyperscale providers - AWS, Azure, and Google. Over the last year we saw that a lot of developers need to learn how to do their job in the cloud and we see this DevOps movement that we are catering to with our content," stated Alessandro Fasan, Head of Global Sales at Cloud Academy, in this SYS-CON.tv interview at 20th Cloud Expo, held June 6-8, 2017, at the Javits Center in New York City, NY.
Enterprises are moving to the cloud faster than most of us in security expected. CIOs are going from 0 to 100 in cloud adoption and leaving security teams in the dust. Once cloud is part of an enterprise stack, it’s unclear who has responsibility for the protection of applications, services, and data. When cloud breaches occur, whether active compromise or a publicly accessible database, the blame must fall on both service providers and users. In his session at 21st Cloud Expo, Ben Johnson, C...
21st International Cloud Expo, taking place October 31 - November 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA, 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. Me...
Many organizations adopt DevOps to reduce cycle times and deliver software faster; some take on DevOps to drive higher quality and better end-user experience; others look to DevOps for a clearer line-of-sight to customers to drive better business impacts. In truth, these three foundations go together. In this power panel at @DevOpsSummit 21st Cloud Expo, moderated by DevOps Conference Co-Chair Andi Mann, industry experts will discuss how leading organizations build application success from all...
SYS-CON Events announced today that mruby Forum will exhibit at the Japan External Trade Organization (JETRO) Pavilion at SYS-CON's 21st International Cloud Expo®, which will take place on Oct 31 – Nov 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA. mruby is the lightweight implementation of the Ruby language. We introduce mruby and the mruby IoT framework that enhances development productivity. For more information, visit http://forum.mruby.org/.
Cloud-based disaster recovery is critical to any production environment and is a high priority for many enterprise organizations today. Nearly 40% of organizations have had to execute their BCDR plan due to a service disruption in the past two years. Zerto on IBM Cloud offer VMware and Microsoft customers simple, automated recovery of on-premise VMware and Microsoft workloads to IBM Cloud data centers.
Elon Musk is among the notable industry figures who worries about the power of AI to destroy rather than help society. Mark Zuckerberg, on the other hand, embraces all that is going on. AI is most powerful when deployed across the vast networks being built for Internets of Things in the manufacturing, transportation and logistics, retail, healthcare, government and other sectors. Is AI transforming IoT for the good or the bad? Do we need to worry about its potential destructive power? Or will we...
Why Federal cloud? What is in Federal Clouds and integrations? This session will identify the process and the FedRAMP initiative. But is it sufficient? What is the remedy for keeping abreast of cutting-edge technology? In his session at 21st Cloud Expo, Rasananda Behera will examine the proposed solutions: Private or public or hybrid cloud Responsible governing bodies How can we accomplish?
Today traditional IT approaches leverage well-architected compute/networking domains to control what applications can access what data, and how. DevOps includes rapid application development/deployment leveraging concepts like containerization, third-party sourced applications and databases. Such applications need access to production data for its test and iteration cycles. Data Security? That sounds like a roadblock to DevOps vs. protecting the crown jewels to those in IT.
SYS-CON Events announced today that Cedexis will exhibit at SYS-CON's 21st International Cloud Expo®, which will take place on Oct 31 – Nov 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA. Cedexis is the leader in data-driven enterprise global traffic management. Whether optimizing traffic through datacenters, clouds, CDNs, or any combination, Cedexis solutions drive quality and cost-effectiveness.