Sweden-based Pharmalink has commenced its Nefecon Phase IIb study in patients with primary IgA nephropathy with the possibility of developing end-stage renal disease.

Nefecon, an enteric formulation of a locally acting corticosteroid, is designed to down-regulate the inflammatory process in the kidneys by inhibiting the gastrointestinal immune system.

Pharmalink clinical development director Alex Mercer said no approved treatments are available on the market today for IgA nephropathy, 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," Mercer said.

"Nefecon, an enteric formulation of a locally acting corticosteroid, is designed to down-regulate the inflammatory process in the kidneys by inhibiting the gastrointestinal immune system."

"Pharmalink hopes to bring a new medicine to patients for early treatment, halting disease progression and further loss of renal function.

"We look forward to confirming the highly promising results we have seen so far with Nefecon and to advancing the product in this pivotal Phase IIb trial."

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

The multi-centre, randomised study is designed to assess the efficacy and safety of two different doses of Nefecon in 90 primary IgA nephropathy patients with the risk of developing an end-stage renal disease.

Double-blinded placebo controlled study’s primary objective is to assess if patients on Nefecon have a larger mean reduction in proteinuria compared to patients on placebo.

The company expects the top line results from the study in the first half of 2015.

Nefecon demonstrated positive safety and efficacy profile and was well tolerated in the open-labelled Phase IIa trial involving 16 patients at trial centres in Sweden.