Kiniksa will now focus its development efforts on the IL-1 blocker KPL-387, which it is testing for recurrent pericarditis with Phase II/III trials planned for mid-2025.
Kiniksa Pharmaceuticals will no longer move forward with its Sjögren’s syndrome drug development program and will walk away from an investigational antibody licensed from AstraZeneca, the London-based biotech announced on Tuesday.
In Sjögren’s, Kiniksa was testing abiprubart, a monoclonal antibody that targets the CD40 protein, which is highly expressed in specific types of immune cells. In autoimmune diseases such as Sjögren’s, this mode of action could potentially disrupt pathological pathways that would otherwise culminate in a defective immune response that attacks healthy cells.
Before being shelved, abiprubart was one of Kiniksa’s most mature assets. In July 2024, the biotech kicked off its Phase IIb study for the asset, testing biweekly and monthly dosing schedules in approximately 200 patients.
The decision to discontinue abiprubart is in line with Kiniksa’s “strategic reprioritization of its portfolio and certain capital allocation considerations,” the biotech wrote in an SEC filing dated Feb. 21. The company will “immediately” stop enrollment into abiprubart’s mid-stage study and start winding down activities linked to the asset, while looking for strategic alternatives.
Abiprubart’s termination has already cost Kiniksa $19 million, and the biotech expects to incur around $14 million to $17 million more in discontinuation expenses, mostly attributed to “contract termination costs” for existing supply agreements. Kiniksa expects to wrap up wind-down activities for abiprubart by the end of the year.
Other players in the Sjögren’s syndrome space include J&J and Horizon Therapeutics, which reported respective mid-stage wins in June 2024 and January 2023.
Also on Tuesday, Kiniksa announced it is terminating its licensing deal with AstraZeneca’s MedImmune for the GM-CSF blocker mavrilimumab. The asset, also a monoclonal antibody, was being tested for the chronic autoimmune disease giant cell arteritis and COVID-19-related acute respiratory distress syndrome.
Kiniksa entered its licensing deal with MedImmune in December 2017, paying $23 million in upfront, pass-through and certain clinical milestone payments. At the time, the London biotech also promised up to $57.5 million in future milestones for the first two programs covered by the contract, plus up to $15 million for additional indications.
In January 2024, however, Kiniksa announced it had slowed down investment into mavrilimumab and was in the process of looking for potential development partners for the asset.
With abiprubart and mavrilimumab discontinued, Kiniksa is down to a completely cardiovascular pipeline—though the indication for its most immature candidate, the IL-1 antagonist KPL-1161, has yet to be disclosed. As per its Tuesday press release, Kiniksa will now focus its development efforts on KPL-387, also an IL-1 blocker, for recurrent pericarditis. The biotech is gearing up for a Phase II/III trial of the asset in mid-2025.
