Syndax Pharmaceuticals Inc. ((SNDX)) announced an update on their ongoing clinical study.
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Study Overview: Syndax Pharmaceuticals Inc. is conducting a Phase 1 study titled A Phase 1, Open-label, Dose-escalation, and Dose-expansion Study to Evaluate Safety, Tolerability, and Clinical Activity of SNDX-5613 in Combination With Intensive Chemotherapy in Participants With Newly Diagnosed Acute Myeloid Leukemias Harboring Alterations in Lysine-specific Methyltransferase 2A (KMT2A/MLL), Nucleophosmin 1 (NPM1), and Nucleoporin 98 (NUP98) Genes. The study aims to assess the safety and effectiveness of SNDX-5613 combined with chemotherapy in treating specific genetic alterations in acute myeloid leukemia (AML), a significant step in advancing treatment options for this aggressive cancer.
Intervention/Treatment: The study tests the experimental drug SNDX-5613, administered orally, alongside a chemotherapy regimen that includes cytarabine and either daunorubicin or idarubicin, followed by high-dose cytarabine (HiDAC) during the consolidation phase. This combination aims to improve treatment outcomes for patients with AML.
Study Design: This interventional study follows a sequential model without masking, focusing primarily on treatment. It includes dose-escalation to determine the maximum tolerated dose of SNDX-5613, followed by dose-expansion to explore safety and preliminary efficacy at these levels.
Study Timeline: The study began on May 21, 2024, with the last update submitted on July 22, 2025. These dates are crucial as they mark the progress and current status of the study, which is still recruiting participants.
Market Implications: The progress of this study could significantly impact Syndax Pharmaceuticals’ stock performance and investor sentiment, as successful results may enhance the company’s position in the oncology market. The study’s focus on genetic alterations in AML also positions Syndax competitively within the industry, potentially influencing market dynamics.
The study is ongoing, and further details are available on the ClinicalTrials portal.