Salarius Pharmaceuticals (Nasdaq: SLRX) has announced the resumption of patient enrollment in a Phase 1/2 clinical trial at MD Anderson Cancer Center (MDACC). The trial is investigating seclidemstat, an oral LSD1 inhibitor, in combination with azacitidine for treating myelodysplastic syndrome (MDS) and chronic myelomonocytic leukemia (CMML). The FDA previously placed a partial clinical hold on the trial due to an unexpected adverse event, but this hold has been lifted after MDACC addressed the FDA’s concerns.
The restart of this trial is a significant development for patients with MDS and CMML, especially those who have relapsed or not responded to hypomethylating agent therapy. Interim results presented in June 2024 showed a promising 43% overall response rate and a median overall survival of 18.5 months in a group of these higher-risk patients. This is notable considering the typical overall survival after failing hypomethylating agents is significantly shorter, ranging from just four to six months. Further data from this trial could solidify seclidemstat’s potential to address an unmet need in this patient population.
The trial evaluates seclidemstat in combination with azacitidine. Earlier data demonstrated a 43% overall response rate in 14 higher-risk MDS and CMML patients who had previously failed hypomethylating agent therapy. Additionally, the reported median overall survival of 18.5 months is substantially higher than the typical 4–6 months survival post-hypomethylating agent failure.
While Salarius is merging with Decoy Therapeutics and focusing on Decoy’s pipeline, the development of seclidemstat for hematologic cancers will continue through this MDACC-led trial. This allows for continued investigation of seclidemstat’s potential benefits while the company explores strategic options for the drug’s future. The continued development of seclidemstat provides hope for patients with these challenging cancers. The data generated from this trial will be crucial for determining the next steps for seclidemstat and could attract potential partners interested in further advancing its development.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.