Drug Discovery and Development

  • Home Drug Discovery and Development
  • Drug Discovery
  • Women in Pharma
  • Oncology
  • Neurological Disease
  • Infectious Disease
  • R&D 100 Awards
  • Pharma 50
    • 2022 Pharma 50
    • 2021 Pharma 50

Bellus Health: Phase 3 Results of Kiacta for AA Amyloidosis

By Drug Discovery Trends Editor | June 21, 2016

Bellus Health Inc., a drug development company focused on rare diseases, today announced top-line results from the Phase 3 study of Kiacta (eprodisate) for the treatment of AA amyloidosis.

In the study, Kiacta did not meet the primary efficacy endpoint in slowing renal function decline. Kiacta was shown to be safe and well tolerated over treatment periods of greater than 4 years. Further analysis of the data is ongoing. 

“While we are disappointed that the Phase 3 study did not meet the primary efficacy endpoint, the full data set will be assessed to determine the best path forward,” said Roberto Bellini, President and Chief Executive Officer of Belllus Health. 

AA amyloidosis is a rare disease secondary to severe chronic inflammation or infection leading to the formation and deposition of amyloid fibrils in organs, often resulting in end-stage renal disease and death. Currently there are no therapies available that target the disease directly. 

The confirmatory Phase 3 study of Kiacta was a global study across more than 70 sites in more than 25 countries that randomized 261 patients to receive either 800mg dose of Kiacta twice daily or placebo. The Phase 3 study was an event driven study that lasted 5 years meeting its completion target of 120 patient events linked to the deterioration of kidney function in January 2016. 

A more detailed data set of the Kiacta Phase 3 study will be presented July 6 at the XV International Symposium on Amyloidosis. 


Filed Under: Drug Discovery

 

Related Articles Read More >

Diversity
Making diversity in clinical research more than a talking point
psychedelic medicine discussed at SXSW
5 headwinds and 5 tailwinds for psychedelic medicine
lab microscope
Accelerating R&D with FAIR data
Kallyope
Kallyope’s focus on the gut-brain axis yields a diverse portfolio

Need Drug Discovery news in a minute?

We Deliver!
Drug Discovery & Development Enewsletters get you caught up on all the mission critical news you need. Sign up today.
Enews Signup
Drug Discovery and Development
  • MassDevice
  • DeviceTalks
  • Medical Design & Outsourcing
  • Medical Tubing + Extrusion
  • Medtech100 Index
  • Medical Design Sourcing
  • Subscribe to our Free E-Newsletter
  • Contact Us
  • About Us
  • Advertise With Us
  • R&D World
  • Drug Delivery Business News
  • Pharmaceutical Processing World

Copyright © 2022 WTWH Media LLC. All Rights Reserved. The material on this site may not be reproduced, distributed, transmitted, cached or otherwise used, except with the prior written permission of WTWH Media
Privacy Policy | Advertising | About Us

Search Drug Discovery & Development

  • Home Drug Discovery and Development
  • Drug Discovery
  • Women in Pharma
  • Oncology
  • Neurological Disease
  • Infectious Disease
  • R&D 100 Awards
  • Pharma 50
    • 2022 Pharma 50
    • 2021 Pharma 50