Keros Therapeutics Provides Update on Phase 2 TROPOS Trial Progress
Keros Therapeutics, Inc. (“Keros” or the “Company”) (Nasdaq: KROS), a clinical-stage biopharmaceutical innovator, has announced some important changes in its ongoing clinical study known as the TROPOS trial. This Phase 2 clinical trial investigates the effects of cibotercept (KER-012) combined with standard therapy for patients suffering from pulmonary arterial hypertension (PAH). Recently, Keros made the decision to voluntarily halt all patient dosing in the trial due to emerging safety concerns, specifically new reports of pericardial effusion adverse events.
The Company had previously paused higher dosage levels of treatment on December 12, 2024, after discovering pericardial effusions at those levels. The latest pause affects all treatment groups, including both the 1.5 mg/kg and placebo groups, as a precautionary measure while the safety review is conducted.
Commitment to Patient Safety
During this challenging moment, Keros maintains that patient safety remains its highest priority. Dr. Jasbir S. Seehra, the Chair and CEO of Keros, expressed disappointment but emphasized the importance of ensuring patient safety above all else. The Company is actively collaborating with clinical investigators and regulatory bodies, including the U.S. Food and Drug Administration (FDA), to ensure that all necessary measures are taken and that patient wellbeing is prioritized. Keros is committed to sharing topline results from the TROPOS trial at the appropriate time, aiming for a presentation in the second quarter of 2025.
TROPOS Trial Overview
Study Structure and Objectives
The TROPOS trial, registered under NCT05975905, is a global, randomized, double-blind, placebo-controlled study. Aimed at evaluating the efficacy of cibotercept when combined with existing PAH therapies, its primary objective is to assess its impact on pulmonary hemodynamics compared to placebo in patients already receiving background treatment for PAH.
Key Goals of the TROPOS Trial
Additionally, the secondary objective focuses on understanding how cibotercept affects the exercise capacity of participants compared to those receiving placebo while on standard therapy. Keros hopes to gain invaluable insights through this study, despite the recent setbacks.
Cibotercept and Its Potential
Cibotercept is a novel therapeutic designed to target and inhibit the signaling pathways of TGF-? ligands that contribute to smooth muscle hypertrophy and fibrosis. By blocking these pathways, Keros aims to enhance the signaling of bone morphogenic proteins (BMPs), which could lead to promising treatment options for diseases like PAH that are associated with diminished BMP signaling caused by mutations in BMP receptors.
Looking Ahead
Despite the current pause in the TROPOS trial, Keros remains optimistic about the potential of cibotercept in treating PAH and other related cardiovascular disorders. The insights from this trial could pave the way for groundbreaking developments in therapeutic options for patients struggling with these challenging conditions.
Frequently Asked Questions
What is the TROPOS trial about?
The TROPOS trial is a Phase 2 study investigating the effects of cibotercept in patients with pulmonary arterial hypertension (PAH) when combined with standard therapies.
Why was the TROPOS trial halted?
The trial was paused to address safety concerns following reports of adverse events related to pericardial effusion.
What are the primary objectives of the TROPOS trial?
The main goal is to evaluate the impact of cibotercept on pulmonary hemodynamics compared to a placebo.
What is cibotercept?
Cibotercept is a therapeutic agent designed to inhibit TGF-? signaling pathways potentially involved in PAH.
When can we expect the topline data from the TROPOS trial?
Keros aims to present topline data from the trial in the second quarter of 2025.
Investor Contact:
Justin Frantz
jfrantz@kerostx.com
617-221-6042
