Auven Therapeutics and Bellus Health announced the completion of their 5-year Phase 3 confirmatory study testing the efficacy and safety of Kiacta (eprodisate) for the treatment of AA amyloidosis. Top-line results are expected to be announced in the second quarter of 2016.
AA amyloidosis is a complication of a severe chronic inflammation or infection leading to the formation and deposition of amyloid fibrils in organs. The result can lead to end-stage renal disease and death. There are currently no approved treatments for this rare condition.
In previous clinical studies, slowed the decline of renal function in AA amyloidosis patients by interfering with the formation of amyloid fibrils A and its deposition in tissues.
In a press release
, leaders of the two companies comments on the milestone achieved with Kiacta.
“We designed this trial to confirm the results of the prior Phase 2/3 study in which KIACTA™ demonstrated significant delays in AA amyloidosis disease progression, in some cases for a number of years,” said Dr. Peter B. Corr, Co-Founder and Managing General Partner of Auven. “We are very pleased to complete this step in our pivotal study and look forward to reviewing and announcing the top-line results during the second quarter of 2016.”
“The KIACTA™ Phase 3 confirmatory study is the most comprehensive study ever conducted in AA amyloidosis patients,” said Roberto Bellini, President and Chief Executive Officer of BELLUS Health. “We are excited that a key portion of the study is complete and look forward to receiving the top-line data.”
“We anticipate this trial will demonstrate conclusively KIACTA™’s potential to make a major impact in the lives of those who currently have no other treatment options available to them, and we look forward to commencing a formal sale process for KIACTA™ later this year,” said Stephen Evans-Freke, Co-Founder and Managing General Partner of Auven.
For more inforation about AA amyloidosis, visit http://www.amyloidosis.org/facts/aa/