Keros Therapeutics Announces Update on the Phase 2 TROPOS Trial
Keros Therapeutics (NASDAQ: KROS) has announced the voluntary halt of dosing in the 3.0 mg/kg and 4.5 mg/kg treatment arms of its Phase 2 TROPOS trial, which studies cibotercept (KER-012) for pulmonary arterial hypertension (PAH). This decision follows the unanticipated observation of pericardial effusion adverse events.
The 1.5 mg/kg treatment arm continues following a risk-benefit assessment by the independent Data Monitoring Committee and Keros team. The trial is fully enrolled, and the company maintains its timeline to present topline data from all treatment arms in Q2 2025. The FDA and other regulatory authorities have been notified of these developments.
Keros Therapeutics (NASDAQ: KROS) ha annunciato l'interruzione volontaria della somministrazione nei bracci di trattamento da 3.0 mg/kg e 4.5 mg/kg del suo studio di Fase 2 TROPOS, che studia il cibotercept (KER-012) per l'ipertensione arteriosa polmonare (PAH). Questa decisione segue l'osservazione non prevista di eventi avversi di versamento pericardico.
Il braccio di trattamento da 1.5 mg/kg continua a seguito di una valutazione rischi-benefici effettuata dall'indipendente Data Monitoring Committee e dal team di Keros. Lo studio è completamente arruolato e l'azienda mantiene la sua tempistica per presentare i dati preliminari da tutti i bracci di trattamento nel secondo trimestre del 2025. La FDA e altre autorità regolatorie sono state informate di questi sviluppi.
Keros Therapeutics (NASDAQ: KROS) ha anunciado la interrupción voluntaria de la dosificación en los brazos de tratamiento de 3.0 mg/kg y 4.5 mg/kg de su ensayo de Fase 2 TROPOS, que estudia el ciboterecepto (KER-012) para la hipertensión arterial pulmonar (HAP). Esta decisión sigue a la observación no anticipada de eventos adversos por derrame pericárdico.
El brazo de tratamiento de 1.5 mg/kg continúa tras una evaluación de riesgo-beneficio realizada por el Comité de Monitoreo de Datos independiente y el equipo de Keros. El ensayo está completamente inscrito y la empresa mantiene su cronograma para presentar datos preliminares de todos los brazos de tratamiento en el segundo trimestre de 2025. La FDA y otras autoridades regulatorias han sido notificadas de estos desarrollos.
케로스 치료제 (NASDAQ: KROS)는 폐동맥 고혈압(PAH)을 위한 시보테셉트(KER-012)를 연구하는 2상 TROPOS 시험의 3.0 mg/kg 및 4.5 mg/kg 치료군에서 투약을 자발적으로 중단한다고 발표했습니다. 이 결정은 예상치 못한 심장막 삼출 사건의 관찰에 따른 것입니다.
1.5 mg/kg 치료군은 독립적인 데이터 모니터링 위원회 및 케로스 팀의 위험-편익 평가 후 계속 진행됩니다. 시험은 완전 모집되었으며, 회사는 2025년 2분기 내에 모든 치료군의 주요 데이터를 발표할 계획을 유지하고 있습니다. FDA 및 기타 규제 기관에는 이러한 개발 사항이 통보되었습니다.
Keros Therapeutics (NASDAQ: KROS) a annoncé l'arrêt volontaire de l'administration dans les bras de traitement de 3,0 mg/kg et 4,5 mg/kg de son essai de Phase 2 TROPOS, qui étudie le cibotercept (KER-012) pour l'hypertension artérielle pulmonaire (HAP). Cette décision fait suite à l'observation inattendue d'événements indésirables liés à un épanchement péricardique.
Le bras de traitement de 1,5 mg/kg se poursuit suite à une évaluation des risques et bénéfices réalisée par le Comité de Surveillance des Données indépendant et l'équipe de Keros. L'essai est entièrement inscrit et la société maintient son calendrier pour présenter les données préliminaires de tous les bras de traitement au deuxième trimestre 2025. La FDA et d'autres autorités réglementaires ont été informées de ces développements.
Keros Therapeutics (NASDAQ: KROS) hat die freiwillige Einstellung der Dosierung in den Behandlungsarmen von 3,0 mg/kg und 4,5 mg/kg in seiner Phase-2-Studie TROPOS, die Cibotercept (KER-012) für pulmonale arterielle Hypertonie (PAH) untersucht, bekannt gegeben. Diese Entscheidung folgt der unerwarteten Beobachtung von perikardialen Ergussnebenwirkungen.
Der Behandlungsarm von 1,5 mg/kg wird nach einer Risiko-Nutzen-Bewertung durch das unabhängige Datenüberwachungskomitee und das Keros-Team fortgesetzt. Die Studie ist vollständig rekrutiert, und das Unternehmen hält an seinem Zeitplan fest, die vorläufigen Daten aus allen Behandlungsarmen im zweiten Quartal 2025 zu präsentieren. Die FDA und andere Regulierungsbehörden wurden über diese Entwicklungen informiert.
- Trial continues with 1.5 mg/kg treatment arm after safety review
- Company maintains Q2 2025 timeline for topline data presentation
- Trial is fully enrolled
- Voluntary halt of 3.0 mg/kg and 4.5 mg/kg treatment arms due to safety concerns
- Pericardial effusion adverse events observed in trial participants
- Potential regulatory scrutiny following safety concerns
Insights
Pericardial effusion, the accumulation of fluid around the heart, is a serious safety signal that warrants careful investigation. This could potentially lead to additional safety monitoring requirements or dosing restrictions if the drug advances. The timing impact appears as topline data remains scheduled for Q2 2025, but the safety profile may affect the drug's competitive positioning in the PAH market.
For a clinical-stage biotech company with
- Keros will host an update call and webcast today, December 12, 2024, at 8:00 a.m. ET
LEXINGTON, Mass., Dec. 12, 2024 (GLOBE NEWSWIRE) -- Keros Therapeutics, Inc. (“Keros” or the “Company”) (Nasdaq: KROS), a clinical-stage biopharmaceutical company focused on developing and commercializing novel therapeutics to treat a wide range of patients with disorders that are linked to dysfunctional signaling of the transforming growth factor-beta (“TGF-ß”) family of proteins, today announced that it has voluntarily halted dosing in the 3.0 mg/kg and 4.5 mg/kg treatment arms in the ongoing TROPOS trial, a Phase 2 clinical trial of cibotercept (KER-012) in combination with background therapy in patients with pulmonary arterial hypertension (“PAH”), based on a safety review due to the unanticipated observation of pericardial effusion adverse events in the trial.
“We are working diligently to gain a better understanding of these unanticipated findings,” said Jasbir S. Seehra, Ph.D., Chair and CEO. “Above all, patient safety is our top priority when conducting any clinical trial. We will work with the investigators, the U.S. Food and Drug Administration (“FDA”) and other relevant regulatory authorities to address this as quickly as possible.”
The TROPOS trial is fully enrolled, and dosing in the 1.5 mg/kg treatment arm remains ongoing following completion of a risk and benefit assessment of the data from the ongoing trial that was conducted by the independent Data Monitoring Committee (“DMC”) followed by a select group of unblinded individuals at Keros. The decision to halt the dosing in 3.0 mg/kg and 4.5 mg/kg treatment arms and continue dosing in the 1.5 mg/kg treatment arm was made in consultation with the independent DMC for the trial. The Company intends to continue ongoing safety and efficacy data collection for all treatment arms in the trial. The Company has notified investigators and certain regulatory authorities, including the FDA, about this decision, and is in the process of notifying other relevant regulatory authorities. The Company continues to expect to present topline data from all treatment arms in this trial in the second quarter of 2025. The Company is working diligently to investigate and address this matter and expects to provide additional information when there is a material update.
Conference Call and Webcast Information
Keros will host a conference call and webcast today, December 12, 2024, at 8:00 a.m. Eastern time. The conference call will be webcast live at: https://event.choruscall.com/mediaframe/webcast.html?webcastid=6k3fkWkW. The live teleconference may be accessed by dialing (877) 407-0309 (domestic) or (201) 389-0853 (international). An archived version of the call will be available in the investors section of the Keros website at http://ir.kerostx.com/ for 90 days following the conclusion of the call.
About TROPOS (NCT05975905)
TROPOS is a randomized, double-blind, placebo-controlled, global Phase 2 clinical trial to evaluate cibotercept in combination with background therapy in patients with PAH. The primary objective of this trial is to evaluate the effect of cibotercept on pulmonary hemodynamics compared to placebo in participants on background PAH therapy. The key secondary objective of this trial is to evaluate the effect of cibotercept on exercise capacity compared to placebo on participants on background PAH therapy.
About Cibotercept
Cibotercept is designed to bind to and inhibit the signaling of TGF-β ligands that stimulate smooth muscle hypertrophy and fibrosis, including activin A, activin B and myostatin. Keros believes that cibotercept has the potential to increase the signaling of bone morphogenic protein (“BMP”) pathways through this inhibition of activin A and activin B signaling, and consequently treat diseases such as PAH that are associated with reduced BMP signaling due to inactivating mutations in the BMP receptors. Cibotercept is being developed for the treatment of PAH and for the treatment of cardiovascular disorders.
Cautionary Note Regarding Forward-Looking Statements
Statements contained in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. Words such as “expect” and “will” or similar expressions are intended to identify forward-looking statements. Examples of these forward-looking statements include statements concerning: Keros’ expectations regarding its progress and the design, objectives and timing of its clinical trial for cibotercept, including expected timing for data readout for the TROPOS trial; the response of FDA or any regulatory authorities to our voluntary actions with respect to the TROPOS trial; and the potential of cibotercept to increase the signaling of BMP pathways to treat diseases such as PAH. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. These risks and uncertainties include, among others: Keros’ limited operating history and historical losses; Keros’ ability to raise additional funding to complete the development and any commercialization of its product candidates; Keros’ dependence on the success of its product candidates, cibotercept, elritercept and KER-065; that Keros may be delayed in initiating, enrolling or completing any clinical trials; the risk that initial or interim results from a clinical trial may not be predictive of the final results of the trial or the results of future trials; competition from third parties that are developing products for similar uses; Keros’ ability to obtain, maintain and protect its intellectual property; and Keros’ dependence on third parties in connection with manufacturing, clinical trials and preclinical studies.
These and other risks are described more fully in Keros’ filings with the Securities and Exchange Commission (“SEC”), including the “Risk Factors” section of the Company’s Quarterly Report on Form 10-Q, filed with the SEC on November 6, 2024, and its other documents subsequently filed with or furnished to the SEC. All forward-looking statements contained in this press release speak only as of the date on which they were made. Except to the extent required by law, Keros undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.
Investor Contact:
Justin Frantz
jfrantz@kerostx.com
617-221-6042
FAQ
Why did Keros Therapeutics (KROS) halt parts of the TROPOS Phase 2 trial?
Which treatment arm of KROS TROPOS trial is still continuing?
When will Keros (KROS) release topline data for the TROPOS trial?
What is the current enrollment status of KROS TROPOS Phase 2 trial?
What regulatory actions has Keros (KROS) taken regarding the TROPOS trial safety concerns?
