Syndax Pharmaceuticals Inc. ((SNDX)) announced an update on their ongoing clinical study.
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Study Overview: Syndax Pharmaceuticals Inc. is conducting a clinical study titled A Phase 1/2, Open-label, Dose-Escalation and Dose-Expansion Cohort Study of SNDX-5613 in Patients With Relapsed/Refractory Leukemias, Including Those Harboring an MLL/KMT2A Gene Rearrangement or Nucleophosmin 1 (NPM1) Mutation. The study aims to determine the maximum tolerated dose and recommended Phase 2 dose of revumenib, as well as its efficacy, safety, and tolerability in patients with specific types of acute leukemia.
Intervention/Treatment: The study tests the drug revumenib, administered orally, with the goal of identifying its optimal dosage and assessing its therapeutic impact on various forms of acute leukemia. Cobicistat is also used in one of the study arms to assess drug interactions.
Study Design: This interventional study employs a sequential model with no masking. Phase 1 focuses on dose escalation to identify safe dosage levels, while Phase 2 expands into specific leukemia cohorts to evaluate treatment effectiveness.
Study Timeline: The study began on August 16, 2019, with the latest update submitted on September 2, 2025. These dates are crucial for tracking the study’s progress and ensuring timely updates for stakeholders.
Market Implications: The ongoing study could significantly impact Syndax Pharmaceuticals’ stock performance, as positive results may enhance investor confidence and position the company favorably against competitors in the leukemia treatment market. The study’s progress is closely watched by investors interested in the biotech sector.
The study is currently recruiting, with further details available on the ClinicalTrials portal.