Welcome!

News Feed Item

Pharmalink Completes Enrolment of Patients into Phase IIB Clinical Study (Nefigan) of Nefecon®

STOCKHOLM, January 13, 2014 /PRNewswire/ --

Pharmalink AB, a specialty pharma company focused on orphan and niche products, announces it has completed recruitment of patients into a Phase IIb NEFIGAN study of its orphan drug product, Nefecon® (http://www.nefigan.net). Pharmalink expects to announce top-line results in mid-2015.

The Phase IIb study is a multi-center, randomized, double-blinded placebo-controlled clinical trial designed to assess the efficacy and safety of two different doses of Nefecon in 90 IgA nephropathy patients at risk of end-stage renal failure, despite optimized standard-of-care therapy. The study is being conducted in 62 renal centers in ten European countries.

The primary efficacy objective of the study is to investigate whether patients on Nefecon achieve a larger mean reduction in proteinuria compared to patients on placebo. Randomized patients are treated for nine months following a six-month run-in phase in which standard-of-care therapy is optimized. The study will enable an optimal dose of Nefecon to be selected for a Phase III registration trial.

Alex Mercer, Clinical Development Director of Pharmalink, said: "The response to this study from renal disease specialists across Europe has been outstanding and to complete recruitment within one year in this rare disease is a sign of the great interest the study has generated. This enthusiasm bodes well for the future as we advance Nefecon towards marketing approval. If the highly promising results we have seen in earlier studies are confirmed in NEFIGAN, we trust that Nefecon can become an effective new treatment for IgA nephropathy patients at risk of renal failure."

Bengt Fellström, MD, PhD, Professor of Medicine at Uppsala University Hospital, Sweden and Principal Investigator of the NEFIGAN study, added: "IgA nephropathy is a disease with a high unmet medical need. Progression to renal failure has a terrible impact on patients' quality of life and is a high burden to health care systems. A new medicine for early treatment with the potential to stop disease progression and minimize any further loss of renal function would be very welcome news to patients and clinicians alike. I am delighted at the response we have had from the renal disease community to this study, which has led to its rapid recruitment, and now look forward to the results in due course."

About Nefecon®

Nefecon is a potential disease-modifying treatment for patients with primary IgA nephropathy at risk of developing end-stage renal disease, an indication with a high unmet medical need and no approved treatment. Early treatment with Nefecon provides a therapy to slow or halt disease progression and further loss of renal function, preventing the need for dialysis and transplantation.

Nefecon is an enteric formulation of a locally-acting and potent corticosteroid that down-regulates the disease process in the kidney through suppression of the gastrointestinal immune system thus exploiting the pivotal role the gastrointestinal tract plays in the overall immune response. Nefecon has received orphan drug designation from the US Food and Drug Administration (FDA).

Pharmalink anticipates seeking a commercial partner for Nefecon in all territories.

About IgA Nephropathy

IgA nephropathy is the most common form of glomerulonephritis (inflammation of the kidney glomeruli). The disease is characterized by deposits, predominantly containing polymeric IgA antibody, in the kidney that cause inflammation and renal damage.

IgA nephropathy can occur at any age, but the clinical onset is commonly during the second or third decades of life. It has been estimated that 20-40% of patients with IgA nephropathy slowly progress to renal failure, often referred to as end-stage renal disease within 5-30 years following diagnosis. This patient population is estimated at approximately 200,000 in major markets.

Patients suffering renal failure require dialysis or kidney transplantation. IgA nephropathy accounts for 10% of renal transplants among patients with primary glomerulonephritis in the US and between 7-20% of patients in Europe and Australia in long-term dialysis and renal transplantation programs.

About Pharmalink

Pharmalink is a Swedish specialty pharma company developing high-value products for niche indications. Pharmalink draws on its extensive experience of pharmaceutical development and marketing to identify and progress products that address significant unmet medical needs. With a successful history in pharmaceutical sales and marketing, and highly experienced, dynamic management team, Pharmalink is focused on the development and commercialization of valuable, de-risked projects. It has two late-stage clinical phase products under development, Nefecon® and Busulipo™. Pharmalink is actively seeking opportunities to acquire or in-license product opportunities in niche and hospital care indications. Visit http://www.pharmalink.se for further information.

http://www.pharmalink.se


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
SYS-CON Events announced today that Enzu, a leading provider of cloud hosting solutions, will exhibit at SYS-CON's 18th International Cloud Expo®, which will take place on June 7-9, 2016, at the Javits Center in New York City, NY. Enzu’s mission is to be the leading provider of enterprise cloud solutions worldwide. Enzu enables online businesses to use its IT infrastructure to their competitive advantage. By offering a suite of proven hosting and management services, Enzu wants companies to foc...
So, you bought into the current machine learning craze and went on to collect millions/billions of records from this promising new data source. Now, what do you do with them? Too often, the abundance of data quickly turns into an abundance of problems. How do you extract that "magic essence" from your data without falling into the common pitfalls? In her session at @ThingsExpo, Natalia Ponomareva, Software Engineer at Google, will provide tips on how to be successful in large scale machine lear...
SYS-CON Events announced today that Stratoscale, the software company developing the next generation data center operating system, will exhibit at SYS-CON's 18th International Cloud Expo®, which will take place on June 7-9, 2016, at the Javits Center in New York City, NY. Stratoscale is revolutionizing the data center with a zero-to-cloud-in-minutes solution. With Stratoscale’s hardware-agnostic, Software Defined Data Center (SDDC) solution to store everything, run anything and scale everywhere...
Digital payments using wearable devices such as smart watches, fitness trackers, and payment wristbands are an increasing area of focus for industry participants, and consumer acceptance from early trials and deployments has encouraged some of the biggest names in technology and banking to continue their push to drive growth in this nascent market. Wearable payment systems may utilize near field communication (NFC), radio frequency identification (RFID), or quick response (QR) codes and barcodes...
Angular 2 is a complete re-write of the popular framework AngularJS. Programming in Angular 2 is greatly simplified – now it's a component-based well-performing framework. This immersive one-day workshop at 18th Cloud Expo, led by Yakov Fain, a Java Champion and a co-founder of the IT consultancy Farata Systems and the product company SuranceBay, will provide you with everything you wanted to know about Angular 2.
You think you know what’s in your data. But do you? Most organizations are now aware of the business intelligence represented by their data. Data science stands to take this to a level you never thought of – literally. The techniques of data science, when used with the capabilities of Big Data technologies, can make connections you had not yet imagined, helping you discover new insights and ask new questions of your data. In his session at @ThingsExpo, Sarbjit Sarkaria, data science team lead ...
Unless you don’t use the internet, don’t live in California, or haven’t been paying attention to the recent news… you should be aware that self-driving cars are on their way to becoming a reality. I have seen them – they are real. If you believe in the future reality of self-driving cars, then continue reading on. If you don’t believe in the future possibilities, then I am not sure what to do to convince you other than discuss the very real changes that will roll out with the consumer producti...
SYS-CON Events announced today that Men & Mice, the leading global provider of DNS, DHCP and IP address management overlay solutions, will exhibit at SYS-CON's 18th International Cloud Expo®, which will take place on June 7-9, 2016, at the Javits Center in New York City, NY. The Men & Mice Suite overlay solution is already known for its powerful application in heterogeneous operating environments, enabling enterprises to scale without fuss. Building on a solid range of diverse platform support,...
SYS-CON Events announced today that Peak 10, Inc., a national IT infrastructure and cloud services provider, will exhibit at SYS-CON's 18th International Cloud Expo®, which will take place on June 7-9, 2016, at the Javits Center in New York City, NY. Peak 10 provides reliable, tailored data center and network services, cloud and managed services. Its solutions are designed to scale and adapt to customers’ changing business needs, enabling them to lower costs, improve performance and focus inter...
You deployed your app with the Bluemix PaaS and it's gaining some serious traction, so it's time to make some tweaks. Did you design your application in a way that it can scale in the cloud? Were you even thinking about the cloud when you built the app? If not, chances are your app is going to break. Check out this webcast to learn various techniques for designing applications that will scale successfully in Bluemix, for the confidence you need to take your apps to the next level and beyond.
In his session at @ThingsExpo, Chris Klein, CEO and Co-founder of Rachio, will discuss next generation communities that are using IoT to create more sustainable, intelligent communities. One example is Sterling Ranch, a 10,000 home development that – with the help of Siemens – will integrate IoT technology into the community to provide residents with energy and water savings as well as intelligent security. Everything from stop lights to sprinkler systems to building infrastructures will run ef...
In the world of DevOps there are ‘known good practices’ – aka ‘patterns’ – and ‘known bad practices’ – aka ‘anti-patterns.' Many of these patterns and anti-patterns have been developed from real world experience, especially by the early adopters of DevOps theory; but many are more feasible in theory than in practice, especially for more recent entrants to the DevOps scene. In this power panel at @DevOpsSummit at 18th Cloud Expo, moderated by DevOps Conference Chair Andi Mann, panelists will dis...
Whether your IoT service is connecting cars, homes, appliances, wearable, cameras or other devices, one question hangs in the balance – how do you actually make money from this service? The ability to turn your IoT service into profit requires the ability to create a monetization strategy that is flexible, scalable and working for you in real-time. It must be a transparent, smoothly implemented strategy that all stakeholders – from customers to the board – will be able to understand and comprehe...
See storage differently! Storage performance problems have only gotten worse and harder to solve as applications have become largely virtualized and moved to a cloud-based infrastructure. Storage performance in a virtualized environment is not just about IOPS, it is about how well that potential performance is guaranteed to individual VMs for these apps as the number of VMs keep going up real time. In his session at 18th Cloud Expo, Dhiraj Sehgal, in product and marketing at Tintri, will discu...
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.