Salarius Pharmaceuticals, Inc. announced U.S. Food and Drug Administration (FDA) clearance of the company’s investigational new drug (IND) application to commence a Phase 1 clinical trial with SP-3164 in patients with relapsed/refractory non-Hodgkin lymphoma (NHL). Salarius expects to begin treating patients in the dose-escalation portion of the trial in the second half of 2023 to evaluate safety, clinical activity, pharmacokinetics and pharmacodynamics. During the trial, Salarius will be assessing the applicability of the gene signature in predicting response to SP-3164.

Previous research with similar agents indicates that patients with an identifiable gene signature may be more likely to respond to SP-3164 treatment. SP-3164 treatment.