Kira to Test KP-104 With KORU’s Infusion Device in SLE Phase 2 Trial

Therapy is designed to suppress blood clots from thrombotic microangiopathy

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by Steve Bryson PhD |

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Kira Pharmaceuticals will test KP-104, an investigational therapy for a blood-clotting disorder associated with systemic lupus erythematosus (SLE), using KORU Medical Systems’ easy-to-use subcutaneous (under-the-skin) Freedom System infusion device.

“We selected KORU Medical based on their track record of helping patients receive high-value therapeutics subcutaneously in the comfort of their home,” said Chaomei He, Kira’s head of chemistry, manufacturing, and controls, in a press release. “The Freedom System’s ease of use, global regulatory approvals, experience with tens of thousands of patients, and ability to rapidly enter the clinic gave us confidence that KORU was the right partner for our KP-104 program.”

The blood clotting disorder, called thrombotic microangiopathy (TMA), is a severe complication of SLE that leads to poor patient outcomes, with the current standard-of-care treatments lacking long-term benefits.

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TMA can be triggered by the abnormal activation of the complement pathway, a part of the immune system that helps kill and clear microbes. A feature of TMA is the destruction of red blood cells, low platelet counts, and organ damage caused by tiny clots forming in small blood vessels.

KP-104 is a first-in-class therapeutic candidate designed to sustainably suppress the overactive complement response, thereby preventing blood clots and organ damage. It’s been successfully evaluated in a Phase 1 first-in-human study that showed its bifunctional mechanism of action that allows it to simultaneously block two different complement branches.

Kira is planning a Phase 2 trial (NCT05504187) to test KP-104’s effectiveness, tolerability, and pharmacological properties in up to 24 adult SLE patients, ages 18–65, with evidence of TMA.

The therapy will be administered in the study using KORU’s Freedom System, which will provide a safe and straightforward infusion option that trial participants can use at home.

“We are privileged to work with Kira and help them achieve their mission of helping patients living with complement-mediated disease by providing treatment at home,” said Linda Tharby, KORU’s president and CEO. “The expansion of our work with Kira and progression into [Phase 2] studies is another important milestone in our strategy to grow our novel therapies pipeline in multiple therapeutic areas.”

Kira is also assessing the therapeutic potential of KP-104 using the KORU’s Freedom System in two other kidney-related indications: IgA neuropathy and complement 3 glomerulopathy.