Electra Therapeutics Receives FDA Breakthrough Therapy and EMA Priority Medicines Designations for ELA026 in Secondary Hemophagocytic Lymphohistiocytosis (sHLH)
ELA026 has demonstrated promising potential as a frontline treatment for patients with sHLH, a hyperinflammatory disease with high mortality and significant unmet medical need
Electra has initiated the SURPASS global pivotal trial evaluating ELA026 in patients with sHLH
SOUTH SAN FRANCISCO, Calif., Oct. 22, 2025 (GLOBE NEWSWIRE) -- Electra Therapeutics, a clinical stage biotechnology company pioneering therapies against novel targets for diseases in immunology and cancer, today announced that ELA026 has received U.S. Food and Drug Administration (FDA) Breakthrough Therapy designation (BTD) and European Medicines Agency (EMA) Priority Medicines (PRIME) designation for the treatment of secondary hemophagocytic lymphohistiocytosis (sHLH). ELA026, Electra’s lead drug candidate, is the first investigational therapy to receive BTD and PRIME designations for sHLH, underscoring its potential to address this life-threatening condition with significant unmet medical need. Electra’s SURPASS study, a global pivotal Phase 2/3 trial of ELA026 in sHLH, is enrolling at research sites across U.S. and Europe and has begun dosing patients (NCT05416307).
The BTD and PRIME designations are supported by positive results from the completed Phase 1b study of ELA026 in sHLH. Among patients with malignancy-associated HLH (mHLH), the subgroup associated with the poorest prognosis, 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.
“Receiving FDA BTD and EMA PRIME designations reinforces ELA026’s potential to deliver meaningful benefit for patients with sHLH, a disease with limited treatment options and a devastating prognosis,” said Kim-Hien Dao, DO, PhD, Chief Medical Officer of Electra Therapeutics. “These recognitions reflect the compelling Phase 1b results demonstrating substantial improvement over available therapies. We are working closely with regulatory agencies and leveraging these designations to accelerate development and bring ELA026 to patients as quickly as possible.”
About Breakthrough Therapy Designation and Priority Medicine
FDA Breakthrough Therapy Designation (BTD) is intended to expedite the development and review of a medicine to treat a serious or life-threatening condition, where preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over available therapies on clinically significant endpoints. The designation allows for more intensive FDA guidance, an organizational commitment involving senior managers, and eligibility for rolling review and priority review. EMA Priority Medicine (PRIME) designation provides early and proactive support to innovative therapies that address conditions with significant unmet need or that provide a major advantage over existing options. Acceptance to the program offers enhanced interaction and potential accelerated assessment.
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 is a clinical stage biotechnology company pioneering therapies against novel targets for diseases in immunology and cancer. The company’s lead product candidate, ELA026, is a first-in-class monoclonal antibody that targets signal regulatory proteins (SIRP) on immune cells to selectively deplete pathological myeloid cells and T lymphocytes. ELA026 is currently in pivotal development for secondary hemophagocytic lymphohistiocytosis (sHLH) and is also being evaluated in additional indications. Electra is further advancing a second SIRP-targeted program, ELA822, designed to selectively deplete activated T lymphocytes, with broad potential across immunology and inflammation (I&I). For more information, please visit www.electra-therapeutics.com and follow us on LinkedIn.
Media Contact: Kathryn Morris The Yates Network 914-204-6412 kathryn@theyatesnetwork.com
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