Salarius Pharmaceuticals, Inc. (NASDAQ:SLRX) successfully completed the pre-IND (Investigational New Drug) meeting process with the U.S. Food and Drug Administration (FDA) for SP-3164 in hematological cancers and solid tumors.
The company is planning to submit an IND application in 2023, following the pre-IND meeting process, obtained valuable FDA input that provided clarity on preclinical, clinical, and other regulatory matters.
David Arthur, CEO, said, ”The successful completion of the pre-IND meeting process supports our plan to initiate the first clinical trial with SP-3164 in 2023. We look forward to having multiple clinical programs across two important drug classes: protein degradation with SP-3164 and protein inhibition with seclidemstat."
Salarius anticipates to initiate the first clinical trial in the year 2023, upon receiving IND clearance from the FDA.
Salarius Pharmaceuticals shares are trading high 19 percent at $0.19 in the after-hours session.
