7/102 sources · 2 publishersUpdated Oct 8, 18:23 UTC
Edgewise starts Phase 2 trial of EDG-15400 in preserved-ejection-fraction heart failure
Edgewise Therapeutics has treated its first participant in EQUINOX-HFpEF, a Phase 2 study of EDG-15400 for symptomatic heart failure with preserved ejection fraction. The randomized, placebo-controlled study will test safety, tolerability, drug exposure and biological effects. It is planned for about 90 patients, with treatment lasting as long as 12 weeks.
Why it matters
The start of dosing advances Edgewise's EDG-15400 program into mid-stage testing in HFpEF. The company plans to disclose the study design and Phase 1 findings at the HFSA 2026 meeting.
Key facts
- 1Edgewise Therapeutics announced that the first participant has received EDG-15400 in the Phase 2 EQUINOX-HFpEF study. prnewswire.com
- 2The trial is designed to include about 90 HFpEF patients from 30 to 84 years old. prnewswire.com
- 3Study arms use daily oral EDG-15400 at 25 mg or 50 mg, alongside a placebo group, for as long as 12 weeks. prnewswire.com
- 4Eligible patients must have a LVEF of at least 50% and New York Heart Association class II or III symptoms. prnewswire.com
- 5Edgewise has scheduled an EQUINOX-HFpEF trial-design presentation for October 10, 2026 and a Phase 1 presentation for October 12, 2026. prnewswire.com
Open questions
- Material 2's summary says results are expected in 2026, while its body and Material 1 describe planned presentations of trial design and Phase 1 data rather than Phase 2 results.
Summary written by AlphAI from 2 of 2 sources. Not investment advice. Figures are as stated by the linked sources.