“The initiation of the SURPASS pivotal study represents an important milestone for Electra as we take the next step toward bringing ELA026 to patients,” said Kim-Hien Dao, DO, PhD, Chief Medical Officer of Electra Therapeutics.“We are highly encouraged by the compelling clinical efficacy and safety that ELA026 has demonstrated to date as a novel mechanism for treating sHLH. We look forward to collaborating with investigators around the world to generate pivotal data that will further define ELA026's potential to meaningfully improve outcomes for patients with this devastating disease.”

The SURPASS study is an open-label, single-arm Phase 2/3 pivotal study of ELA026 in treatment-naïve adult and pediatric patients with sHLH. Patients will complete a 12-week treatment period, with ELA026 administered either intravenously or subcutaneously. The study includes two cohorts: Cohort A, adult patients with malignancy-associated HLH (mHLH), the subgroup with the poorest prognosis; and Cohort B, an exploratory cohort including adult and pediatric patients with non-malignancy triggered HLH as well as mHLH diagnosed by Optimized HLH Inflammatory (OHI) index criteria. The primary endpoint is 8-week overall survival, using a propensity-weighted comparison of Cohort A against an external retrospective historical control receiving available therapies. Secondary endpoints include overall response by week 4, alive at hospital discharge, and other clinical benefits. Further details are available on clinicaltrials (NCT05416307 ).

Positive results from a completed Phase 1b study demonstrated that in mHLH, frontline treatment with ELA026 achieved 100% overall survival at 8 weeks, 100% overall response rate by week 4, as well as 100% hospital discharge. Pharmacodynamic and HLH-related biomarkers demonstrated that ELA026 rapidly attenuated inflammation in correlation with clinical improvement. ELA026 is the first investigational therapy to receive U.S. Food and Drug Administration Breakthrough Designation (BTD) and European Medicines Agency Priority Medicines (PRIME) designation for sHLH, underscoring its potential to address this life-threatening condition with significant unmet medical need.

About Secondary Hemophagocytic Lymphohistiocytosis (sHLH)

Secondary hemophagocytic lymphohistiocytosis (sHLH) is a rare, life-threatening hyperinflammatory disease with a lack of treatment options. It can be triggered by cancer, infection, autoimmune disease, or immunotherapy. sHLH is associated with a severe inflammatory response that requires immediate intervention. Without effective treatment, patients may experience multiorgan failure and death. sHLH is associated with high mortality early in the disease course, with malignancy-associated HLH (mHLH) patients having a mortality rate of approximately 50% at two months with available therapies.

About Electra Therapeutics

Electra Therapeutics

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