Enliven Therapeutics, Inc. ((ELVN)) announced an update on their ongoing clinical study.
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Enliven Therapeutics, Inc. is conducting a Phase 1 clinical study titled ‘A Phase 1 Study of ELVN-001 for the Treatment of Chronic Myeloid Leukemia With and Without T315I Mutation in Japanese Participants.’ The study aims to assess the safety and tolerability of ELVN-001, a novel drug, in Japanese patients with chronic phase chronic myeloid leukemia (CML) who have not responded to or cannot tolerate at least two prior tyrosine kinase inhibitors (TKIs).
The intervention being tested is ELVN-001, an experimental drug administered orally once or twice daily. It is designed to target chronic myeloid leukemia, particularly in patients with and without the T315I mutation.
The study follows a non-randomized, sequential intervention model and is unmasked, meaning all participants and researchers know the treatment being administered. The primary purpose is treatment-focused, with the study divided into two parts: dose escalation and dose exploration.
The study began on December 16, 2024, with a recent update on June 27, 2025. These dates are crucial as they mark the progress and ongoing nature of the study, indicating it is still in the recruiting phase.
This clinical update may influence Enliven Therapeutics’ stock performance positively, as successful results could enhance investor confidence and market position. The study’s focus on a drug-resistant form of CML could differentiate ELVN-001 from competitors, potentially offering a unique market advantage.
The study is ongoing, and further details can be accessed on the ClinicalTrials portal.