Core Insights - Salarius Pharmaceuticals has resumed patient enrollment in a Phase 1/2 clinical trial for seclidemstat combined with azacitidine, targeting myelodysplastic syndrome (MDS) and chronic myelomonocytic leukemia (CMML) [1][4] - Seclidemstat is a novel oral reversible inhibitor of the LSD1 enzyme, showing promising results in preclinical models by reprogramming cancer cell differentiation and reducing tumor burden [2] - Interim results from the trial indicated a 43% overall response rate among 14 higher-risk MDS and CMML patients, with a median overall survival of 18.5 months [3] Clinical Trial Updates - The trial is being conducted at the University of Texas MD Anderson Cancer Center and is listed on clinicaltrials.gov [1] - The FDA had previously placed the trial under a partial clinical hold due to a serious adverse event, which has now been lifted [4][5] Merger and Strategic Developments - Salarius has signed a definitive agreement to merge with Decoy Therapeutics, which will create a new company focused on peptide conjugate therapeutics [6] - The merger is expected to enhance value through Decoy's innovative pipeline, which addresses unmet needs in respiratory infectious diseases and gastroenterology oncology [6][9] - The combined company plans to integrate Salarius' SP-3164 into a targeted peptide-based drug candidate while continuing the development of seclidemstat [7]
Salarius Pharmaceuticals Announces Patient Enrollment to Resume in Investigator-initiated Phase 1/2 Clinical Trial Using Seclidemstat with Azacitidine to Treat Hematologic Cancers