Enliven Therapeutics, Inc. ((ELVN)) announced an update on their ongoing clinical study.
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Study Overview: Enliven Therapeutics, Inc. is conducting a Phase 1a/1b study titled ‘A Phase 1a/1b Study of ELVN-001 for the Treatment of Chronic Myeloid Leukemia.’ The study aims to evaluate the safety, tolerability, and determine the recommended dose of ELVN-001 in patients with chronic myeloid leukemia (CML), particularly those who are relapsed, refractory, or intolerant to tyrosine kinase inhibitors (TKIs), including those with and without T315I mutations.
Intervention/Treatment: The study investigates the drug ELVN-001, administered orally once or twice daily. It is designed to treat patients with CML by targeting specific mutations that make the disease resistant to existing treatments.
Study Design: This interventional study is non-randomized and follows a sequential intervention model. It is unmasked, meaning all participants and researchers know the treatment being administered. The primary purpose is treatment-focused, aiming to establish the drug’s safety and effective dosage.
Study Timeline: The study began on March 15, 2022, with a primary completion date yet to be announced. The latest update was submitted on July 15, 2025, indicating ongoing recruitment and progress in the study.
Market Implications: The progress of this study could significantly impact Enliven Therapeutics’ stock performance, as positive results may enhance investor confidence and market valuation. The study’s focus on a niche patient group with limited treatment options could position ELVN-001 as a competitive player in the CML treatment market, potentially affecting competitors who do not address this mutation-specific need.
The study is ongoing, with further details available on the ClinicalTrials portal.