Salarius Receives FDA Fast Track Designation for Seclidemstat

Salarius Pharmaceuticals announced its lead investigational drug candidate, Seclidemstat, has been granted Fast Track Designation by the U.S. Food and Drug Administration (FDA) for the treatment of patients with Ewing sarcoma who have relapsed or are refractory to standard-of-care therapy. Seclidemstat, a potent reversible LSD1 inhibitor, is the subject of an ongoing Phase 1/2 clinical study in Ewing sarcoma.

"Securing FDA Fast Track Designation for Seclidemstat in Ewing sarcoma is an achievement for Salarius in the ongoing development of the drug and recognition that there is an unmet need to bring much needed hope to patients and their families suffering through this devastating disease," David Arthur, President and Chief Executive Officer of Salarius, said. "Coupled with Seclidemstat’s previously granted Orphan Drug Designation and Rare Pediatric Disease Designation by the U.S. Food and Drug Administration, we feel well positioned to take advantage of the FDA’s expedited programs for drug development and review."

"Ewing sarcoma is a rare and deadly bone cancer that most often strikes children and young adults and for which there are no targeted therapies approved. Seclidemstat has demonstrated a potential to address this considerable unmet need, and we look forward to rapidly advancing its development so that it soon may be available to those patients most in need," said Damon Reed, M.D., Director of the Adolescent and Young Adult Program at the Moffitt Cancer Center and Principle Investigator of the Salarius Ewing sarcoma clinical trial.

Fast Track is a process designed by the FDA to expedite the development and review of new drugs with the potential to treat serious or life-threatening conditions and fill unmet medical needs. The aim is to streamline regulatory submissions and enable more frequent communications with the agency to assure that questions and issues are resolved quickly, which often leads to earlier drug approval and access by patients.

Seclidemstat is a first-in-class, oral, small molecule designed for the reversible and noncompetitive inhibition of the LSD1 enzyme. Seclidemstat is based on the research of Dr. Sunil Sharma, Salarius’ co-founder, into LDS1 inhibition during his tenure at the University of Utah’s Huntsman Cancer Institute. As a reversible inhibitor, Seclidemstat could offer more efficacy, more flexible dosing and less toxicity. Salarius expects to release early cohort data early next year from its Ewing sarcoma study and a second Phase 1 clinical study in advanced solid tumors, including prostate, breast and ovarian cancers. A preclinical program in glioblastoma is underway at the Barrow Neurological Institute ‘s Ivy Brain Tumor Center.

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