By Chris Wack
Keros Therapeutics Inc. Shares were down 11% to $40.50 after the company reported preliminary topline results from Part 1 of its Phase 1 clinical trial evaluating single and multiple ascending doses of KER-012 in healthy postmenopausal volunteers, showing the treatment was generally well tolerated.
The company said the ongoing trial is designed as a two-part trial to assess the safety, tolerability and pharmacokinetics of KER-012.
In Part 1 of this ongoing trial, 32 subjects received either a single 0.75, 1.5, 3 or 5 mg/kg dose of KER-012 and eight subjects received a single dose of placebo. KER-012 was generally well tolerated in Part 1 of this trial 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 didn’t 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 in Part 1. Additionally, the majority of the adverse events that were observed in Part 1 were mild in severity.
Part 2 of the trial is ongoing, with dosing initiated at 4.5 mg/kg of KER-012, to be administered once every four weeks for three doses. Keros expects to report data from Part 2 of this trial in the second half of 2022.
Following the completion of this Phase 1 clinical trial, Keros expects to start a Phase 2 clinical trial of KER-012 in patients with pulmonary arterial hypertension, and expects to share the trial design for the Phase 2 clinical trial in early 2023.
Write to Chris Wack at [email protected]
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