LAVAL, QC – As part of an update on projects in its pipeline, BELLUS Health reports its partner Auven Therapeutics, who acquired the rights to KIACTA™ from the company in 2010, has decided to terminate the KIACTA™ program for the treatment of AA amyloidosis.
“While the termination of the KIACTA™ AA amyloidosis program is not unexpected considering the negative Phase 3 study results released in June, we are still disappointed for the patients suffering from AA amyloidosis and their families,” said Roberto Bellini, president and CEO of BELLUS Health. He adds however that Auven Therapeutics is still evaluating the conduct of a Phase 2/3 study with KIACTA™ in sarcoidosis, a rare and sometimes lethal lung disease.
Additionally, BELLUS Health says it has received positive regulatory feedback from the FDA in regards to the design of a Phase 2 study for its second pipeline product, Shigamab™ in STEC related Hemolytic Uremic Syndrome (sHUS). sHUS is a rare disease which principally affects the kidneys and often leads to acute dialysis, and in certain cases chronic kidney disease and death, primarily in children. The company is currently planning the next steps for the initiation of this clinical Phase 2 study and is seeking to secure a strategic partner for the further development of Shigamab™.
“We are encouraged that our partner Auven Therapeutics is evaluating a clinical study in sarcoidosis and together with Shigamab™ in sHUS, there is the potential to have two clinical studies started next year,” said Bellini.
The company also provided an update on partnered drug candidates, including AMO-01 for the treatment of Fragile X Syndrome and ALZ-801 for the treatment of Alzheimer’s Disease in APOE4 Homozygous patients.
AMO Pharma Limited, the Company’s licensee of AMO-01 for the treatment of neurologic and psychiatric disorders, is expected to initiate a Phase 2 study on patients with Fragile X Syndrome in the first half of 2017.
Finally, the company reports it is continuing to explore opportunities to expand its pipeline, including through acquisitions and/or in-licensing.