Keros Therapeutics Announces Update on Enrollment in the Phase 2 TROPOS Trial
Keros Therapeutics (Nasdaq: KROS) has announced the closure of screening for its TROPOS trial, a Phase 2 clinical study of cibotercept (KER-012) in combination with background therapy for patients with pulmonary arterial hypertension (PAH). The company expects to complete enrollment by the end of September and present topline data in Q2 2025, earlier than initially anticipated due to high demand and rapid enrollment. Keros, focused on developing therapies for disorders linked to dysfunctional TGF-ß family protein signaling, aims to bring a potentially differentiated treatment option to PAH patients. The company's leadership expressed gratitude to the investigators, research staff, and patients involved in this significant clinical research milestone.
Keros Therapeutics (Nasdaq: KROS) ha annunciato la chiusura dello screening per il suo trial TROPOS, uno studio clinico di Fase 2 su cibotercept (KER-012) in combinazione con terapie di supporto per pazienti con ipertensione arteriosa polmonare (PAH). L'azienda prevede di completare l'arruolamento entro la fine di settembre e presentare dati preliminari nel secondo trimestre del 2025, anticipando i tempi rispetto alle previsioni iniziali grazie all'alta domanda e a un arruolamento rapido. Keros, concentrata sullo sviluppo di terapie per disturbi legati a segnali disfunzionali delle proteine della famiglia TGF-ß, mira a fornire un'opzione terapeutica potenzialmente differenziata per i pazienti con PAH. La leadership dell'azienda ha espresso gratitudine agli investigatori, al personale di ricerca e ai pazienti coinvolti in questo importante traguardo della ricerca clinica.
Keros Therapeutics (Nasdaq: KROS) ha anunciado el cierre de la selección para su ensayo TROPOS, un estudio clínico de Fase 2 de cibotercepto (KER-012) en combinación con terapias de soporte para pacientes con hipertensión arterial pulmonar (PAH). La empresa espera completar la inscripción para finales de septiembre y presentar datos preliminares en el segundo trimestre de 2025, anticipándose a lo previsto gracias a la alta demanda y un rápido proceso de inscripción. Keros, enfocada en desarrollar terapias para trastornos relacionados con la señalización disfuncional de proteínas de la familia TGF-ß, busca ofrecer una opción de tratamiento potencialmente diferenciada para los pacientes con PAH. Los líderes de la empresa expresaron su agradecimiento a los investigadores, al personal de investigación y a los pacientes involucrados en este importante hito de la investigación clínica.
Keros Therapeutics (Nasdaq: KROS)는 TROPOS 시험의 스크리닝 종료를 발표했습니다. 이는 폐동맥고혈압(PAH) 환자를 위한 cibotercept (KER-012)와 배경 요법의 조합에 대한 2상 임상 연구입니다. 회사는 9월 말까지 등록을 완료할 것으로 예상하고 있으며, 2025년 2분기에 주요 데이터를 발표할 예정입니다. 이는 높은 수요와 빠른 등록 덕분에 원래 예상보다 앞당겨진 것입니다. Keros는 TGF-ß 가족 단백질 신호 전달과 관련된 장애에 대한 치료법을 개발하는 데 주력하고 있으며, PAH 환자에게 잠재적으로 차별화된 치료 옵션을 제공하고자 합니다. 회사의 리더십은 이 중요한 임상 연구 이정표에 참여한 연구자, 연구 직원 및 환자들에게 감사를 표했습니다.
Keros Therapeutics (Nasdaq: KROS) a annoncé la clôture du dépistage pour son essai TROPOS, une étude clinique de Phase 2 sur cibotercept (KER-012) en combinaison avec des traitements de fond pour les patients atteints de hypertension artérielle pulmonaire (PAH). L'entreprise s'attend à compléter l'inscription d'ici la fin septembre et à présenter des données préliminaires au deuxième trimestre 2025, plus tôt que prévu en raison d'une forte demande et d'un recrutement rapide. Keros, qui se concentre sur le développement de thérapeutiques pour des troubles liés à des signalisations dysfonctionnelles des protéines de la famille TGF-ß, vise à proposer une option de traitement potentiellement différenciée pour les patients atteints de PAH. La direction de l'entreprise a exprimé sa gratitude aux chercheurs, au personnel de recherche et aux patients impliqués dans cette étape importante de la recherche clinique.
Keros Therapeutics (Nasdaq: KROS) hat den Abschluss des Screenings für seine TROPOS-Studie bekanntgegeben, einer klinischen Phase-2-Studie zu cibotercept (KER-012) in Kombination mit Hintergrundertherapien für Patienten mit pulmonaler arterieller Hypertonie (PAH). Das Unternehmen erwartet, dass es die Einschreibung bis Ende September abschließen wird und im 2. Quartal 2025 erste Ergebnisse präsentieren kann, was aufgrund der hohen Nachfrage und des schnellen Rekrutierungsprozesses früher als ursprünglich prognostiziert geschieht. Keros, das sich auf die Entwicklung von Therapien für Erkrankungen konzentriert, die mit einer dysfunktionalen TGF-ß-Proteinfamilien-Signalisierung verbunden sind, zielt darauf ab, eine potenziell differenzierte Behandlungsoption für PAH-Patienten anzubieten. Die Unternehmensführung drückte ihren Dank an die Forscher, das Forschungsteam und die Patienten aus, die an diesem bedeutenden Meilenstein der klinischen Forschung beteiligt waren.
- Closed screening for TROPOS Phase 2 trial ahead of schedule
- Expects to complete enrollment by end of September 2024
- Anticipates presenting topline data earlier than expected, in Q2 2025
- High demand and rapid enrollment observed in the trial
- None.
Insights
The closing of screening for the TROPOS trial marks a significant milestone in Keros Therapeutics' clinical development program. This Phase 2 trial of cibotercept (KER-012) in combination with background therapy for pulmonary arterial hypertension (PAH) has demonstrated rapid enrollment, reflecting strong interest from both patients and clinicians.
The accelerated timeline, with enrollment expected to complete by September's end and topline data anticipated in Q2 2025, is noteworthy. This efficiency could potentially expedite the drug development process, bringing a new treatment option to PAH patients sooner if results are positive. However, it's important to note that faster enrollment doesn't guarantee positive outcomes and investors should await the topline data before drawing conclusions about the drug's efficacy.
The high demand for trial participation suggests an unmet need in PAH treatment, which could indicate a substantial market opportunity for Keros if cibotercept proves successful. This enthusiasm also bodes well for potential future trials or commercialization efforts.
Keros Therapeutics' announcement reflects positively on their operational efficiency and the potential market interest in cibotercept. The faster-than-expected enrollment could translate to reduced R&D costs and a potentially earlier market entry if the drug proves successful, which is important in the competitive biotech landscape.
Investors should note that Keros is targeting the TGF-ß family of proteins, an area of growing interest in treating various disorders. Success in PAH could potentially open doors for applications in other indications, expanding Keros' pipeline value. However, it's important to remember that Phase 2 results, while important, are not definitive and the path to commercialization remains long and uncertain.
The company's focus on a potentially differentiated treatment in PAH, a market with high unmet needs, could position Keros favorably if cibotercept demonstrates efficacy and safety. Investors should monitor the upcoming topline data closely, as it will be a critical inflection point for the company's valuation and future prospects.
LEXINGTON, Mass., Sept. 03, 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 the Company has closed screening for the TROPOS trial, a Phase 2 clinical trial of cibotercept (KER-012) in combination with background therapy in patients with pulmonary arterial hypertension (“PAH”). As a result, Keros expects to complete enrollment by the end of September and present topline data in the second quarter of 2025.
“We are very pleased to announce the closing of screening in the TROPOS trial,” said Jasbir S. Seehra, Ph.D., Chair and Chief Executive Officer. “The tremendous demand and speed we have observed in enrolling this trial will enable us to present topline data earlier than anticipated, now expected in the second quarter of 2025.”
“We want to thank the TROPOS investigators, research staff and their patients for their participation in this important clinical research,” said Chris Rovaldi, President and Chief Operating Officer. “This milestone, which could not have been achieved without their commitment, brings us one step closer to bringing a potentially differentiated treatment option to patients living with PAH.”
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.
About Keros Therapeutics, Inc.
Keros is 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 TGF-ß family of proteins. The Company is a leader in understanding the role of the TGF-ß family of proteins, which are master regulators of the growth, repair and maintenance of a number of tissues, including blood, bone, skeletal muscle, adipose and heart tissue. By leveraging this understanding, Keros has discovered and is developing protein therapeutics that have the potential to provide meaningful and potentially disease-modifying benefit to patients. Keros’ lead product candidate, elritercept (KER-050), is being developed for the treatment of low blood cell counts, or cytopenias, including anemia and thrombocytopenia, in patients with myelodysplastic syndromes and in patients with myelofibrosis. Keros’ second product candidate, cibotercept, is being developed for the treatment of PAH and for the treatment of cardiovascular disorders. Keros’ third product candidate, KER-065, is being developed for the treatment of obesity and for the treatment of neuromuscular diseases.
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 “expects,” “enable,” “potential,” “will” or similar expressions are intended to identify forward-looking statements. Examples of these forward-looking statements include statements concerning: Keros’ expectations regarding its growth, strategy, progress and the design, objectives and timing of its clinical trials for cibotercept (including expected timing for enrollment completion and data readout for the TROPOS trial). 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, elritercept, cibotercept and KER-065; that Keros may be delayed in initiating, enrolling or completing any clinical 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 August 7, 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
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