SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Electra Therapeutics, Inc., a clinical stage biotechnology company developing antibody therapies against novel targets for immunological diseases and cancer, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for ELA026 for the treatment of secondary hemophagocytic lymphohistiocytosis (sHLH). ELA026, a first-in-class antibody therapy targeting signal regulatory proteins (SIRP), is a novel approach to treat secondary HLH (sHLH), a rare, life-threatening disease for which there is no approved treatment.
“Receiving Fast Track designation for ELA026 reinforces the urgent need for effective treatment options for patients suffering from sHLH,” said Kathy Dong, PharmD, CEO of Electra Therapeutics. “This designation gives us the opportunity to accelerate the development of ELA026, a therapy that we believe has the potential to transform the treatment landscape for sHLH patients. We are committed to advancing this drug candidate with urgency and to work closely with the FDA to bring this innovative therapy to patients as soon as possible.”
The FDA grants investigational medicines Fast Track designation to facilitate the development and expedite the review of medicines that demonstrate the potential to treat serious conditions and fill an unmet medical need. Programs with Fast Track designation can benefit from early and more frequent interactions with the FDA to discuss the product candidate's development plan in addition to a rolling submission of the marketing application. Product candidates with Fast Track designation may also be eligible for priority review and accelerated approval.
About Secondary Hemophagocytic Lymphohistiocytosis
Secondary hemophagocytic lymphohistiocytosis (sHLH) is a rare, life-threatening hyperinflammatory disease for which there is no approved treatment. It can be triggered by cancer, infection, autoimmune disease, or immunotherapy. sHLH is associated with a severe inflammatory response for which patients require immediate intervention. Without effective treatment, patients may experience multiple organ failure and death. sHLH has a high mortality rate during the first months of diagnosis, with malignancy-associated HLH (mHLH) patients having the poorest outcomes.
About Electra Therapeutics
Electra Therapeutics is a clinical stage biotechnology company developing therapies against novel targets for immunological diseases and cancer. The company’s lead product candidate, ELA026, is a first-in-class monoclonal antibody that targets SIRP on the cell surface of myeloid cells and T lymphocytes, and selectively depletes pathological immune cells. ELA026 is in clinical development for secondary hemophagocytic lymphohistiocytosis (sHLH), a rare, life-threatening hyperinflammatory condition for which there is no approved treatment, as well as additional disease indications. For more information, please visit www.electra-therapeutics.com and follow us on LinkedIn.
