Kiniksa Pharmaceuticals Shifts Focus to Cardiovascular Pipeline, Terminates Autoimmune Programs

Kiniksa Pharmaceuticals has announced a significant strategic shift, terminating development programs for two autoimmune assets and refocusing its efforts on cardiovascular disease. This move represents a major realignment of the company's pipeline and resource allocation.

Abiprubart Trial Termination in Sjögren's Syndrome

Kiniksa has made the decision to halt its phase 2b trial of abiprubart in Sjögren's syndrome. This comes as a surprise to industry observers, as the company had previously expressed enthusiasm for the program. Dr. John Paolini, Kiniksa's chief medical officer, had described the company as "certainly very excited" about the trial just six weeks ago.

The termination is part of what Kiniksa describes as a "strategic reprioritization of its portfolio and certain capital allocation considerations." The company estimates the cost of winding down the trial to be between $33 million and $37 million. However, this action will free Kiniksa from the ongoing expenses of a study that was set to continue until 2027.

Abiprubart, an antibody inhibiting CD40-CD154 signaling, was being developed in a competitive space. The drug's potential for monthly subcutaneous dosing was seen as a key differentiator from rivals like Amgen's dazodalibep, which requires intravenous administration.

Mavrilimumab Development Terminated

In addition to the abiprubart decision, Kiniksa has also announced the termination of development for mavrilimumab, a GM-CSF antagonist licensed from AstraZeneca's MedImmune in 2017. The company had paid $23 million in upfront and subsequent payments for the asset but had recently been seeking partnership opportunities to advance its development.

Kiniksa has informed MedImmune of its decision to stop development and terminate the license agreement for mavrilimumab.

Refocus on Cardiovascular Disease Pipeline

With these terminations, Kiniksa is now concentrating its efforts on its cardiovascular disease pipeline. The company's focus is now on KPL-387, an IL-1 antagonist targeting recurrent pericarditis. This program aligns with Kiniksa's already approved drug Arcalyst, which is also indicated for recurrent pericarditis.

A phase 2/3 trial for KPL-387 is scheduled to begin this year, marking a significant step in Kiniksa's new strategic direction.