- Keros Therapeutics Inc (NASDAQ:KROS) announced preliminary topline results from Part 1 of its Phase 1 trial evaluating single and multiple ascending doses of KER-012 in healthy postmenopausal volunteers.
- KER-012 was generally well tolerated in Part 1 at dose levels up to 5 mg/kg, the highest dose level tested when administered as a single dose.
- While one subject withdrew consent after receiving a single 1.5 mg/kg dose of KER-012 and did not complete the safety follow-up, there were no discontinuations due to treatment-related adverse events in Part 1 of this trial.
- No serious adverse events were reported. Additionally, most of the adverse events observed in Part 1 of this trial were mild in severity.
- Part 2 is ongoing, with dosing for Cohort 3 of Part 2 initiated at 4.5 mg/kg of KER-012. Keros expects to report data from Part 2 in 2H 2022.
- After completing this Phase 1 clinical trial, Keros expects to initiate a Phase 2 clinical trial of KER-012 in patients with PAH and expects to share the trial design for the Phase 2 clinical trial in early 2023.
- Price Action: KROS shares traded 17.50% lower at $38.25 on the last check Wednesday.
