#EULAR 2016 – Drug for Children and Teens with Lupus Shows Promise in Early Study

Patricia Inacio, PhD avatar

by Patricia Inacio, PhD |

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Urine biomarkers in pediatric lupus nephritis

lupus nephritis

The Alliance for Children’s Therapeutics presented positive results from an early study of KPI Therapeutics/Kineta’s lead drug candidate, dalazatide, as a possible treatment for children and teenagers with lupus nephritis. The data were given at the recent European League Against Rheumatism’s 17th Annual Congress in London.

A key finding was that “patients with active lupus nephritis express higher levels of the Kv 1.3 channel, the target of Dalazatide, than do patients with inactive disease or healthy volunteers,” Dr. Anne Stevens, the study’s lead author and a researcher at the Seattle Children’s Research Institute, said in a press release.

In both clinical and preclinical trials, dalazatide has shown activity as a strong and selective blocker of the voltage-gated Kv1.3 potassium channel, crucial in the activation of an important class of immune system cells called effector-memory T-cells. (These T-cells are associated with such autoimmune diseases as psoriasis, inflammatory bowel diseases and rheumatoid arthritis, but also have an important role in lupus nephritis).

“T cells from patients with active lupus are sensitive to blockade by Dalazatide, demonstrating ex vivo efficacy of the drug, and provide data to support the design of a clinical trial in patients with lupus,” Dr. Stevens said of the study’s results.

Dalazatide also acts by impairing the release of cytokines, small-secreted proteins that mediate cell-to-cell communication in immune responses and stimulate the movement of cells towards sites of inflammation, infection and trauma. Specifically, dalazatide decreases a group of cytokines associated with active lupus disease, whose release prompts inflammation and damage in lupus patients.

The drug was evaluated for its safety, tolerability and pharmacodynamics in a four-week Phase 1 clinical trial in people with active plaque psoriasis.

“Lupus patients are in urgent need of novel and more effective therapies. We are very encouraged by the positive effect Dalazatide has demonstrated in this study and are working to advance Dalazatide into lupus and lupus nephritis clinical trials,” said Dr. Charles Magness, president and CEO of KPI Therapeutics.

KPI Therapeutics and Kineta, Inc., are developing dalazatide as part of a joint initiative.