Press release
Keros Therapeutics Announces Preliminary Topline Results from its Ongoing Phase 1 Clinical Trial Evaluating KER-012 in Healthy Volunteers
LEXINGTON, Mass., May 18, 2022 (GLOBE NEWSWIRE) -- Keros Therapeutics, Inc. (“Keros”) (Nasdaq: KROS), a clinical-stage biopharmaceutical company focused on
About this update from Keros Therapeutics, Inc.
[{"type":"text","content":"LEXINGTON, Mass., May 18, 2022 (GLOBE NEWSWIRE) -- Keros Therapeutics, Inc. (“Keros”) (Nasdaq: KROS), a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of novel treatments for patients suffering from hematological and musculoskeletal disorders with high unmet medical need, today announced 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. The ongoing trial is designed as a randomized, double-blind, placebo-controlled, 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, each administered subcutaneously with an eight-week safety follow-up. The subjects were enrolled in sequential single-ascending dose escalation cohorts of ten subjects each. 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 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 in Part 1 of this trial. Additionally, the majority of the adverse events that were observed in Part 1 of this trial were mild in severity. Preliminary topline results from Part 1 of this trial include the following: Pharmacokinetic parameters were observed to be generally dose proportional with increasing doses.Maximal target engagement was observed following a single 5 mg/kg dose of KER-012, with a mean (standard deviation, “SD”) 39.6 (12.7)% reduction in follicle-stimulating hormone levels observed on Day 22.Robust increases in markers of bone formation were observed: Bone specific alkaline phosphatase increased, starting at the lowest dose of 0.75 mg/kg, with mean (SD) maximum increases from baseline of 36.4 (4.0)% at the highest dose of 5 mg/kg. No clinically meaningful changes in red blood cells or hemoglobin were observed in Part 1 of this trial. “We are pleased to report the preliminary topline findings from Part 1...