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