Keros Therapeutics presents preclinical data from its KER-012 program at the American Heart Association 2022 Scientific Sessions

Keros Therapeutics presents preclinical data from its KER-012 program at the American Heart Association 2022 Scientific Sessions
Keros Therapeutics, Inc.

Keros Therapeutics, Inc.

LEXINGTON, Mass., Nov. 7, 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 hematologic, pulmonary, and cardiovascular disorders with high unmet medical need, today announced the results of a preclinical study of an investigational form of KER-012 (“RKER-012”) in cardiac and pulmonary pathology in a model of rat established pulmonary artery hypertension (“PAH”), which were presented at the American Heart Association Scientific Sessions 2022 on Monday, November 7, 2022.

“We are pleased to have reported encouraging preclinical data from our KER-012 program showing that RKER-012 treatment led to improved heart and lung function in a rat model of PAH. This cardiopulmonary improvement was associated with reductions in inflammatory and fibrotic markers, including TGFβ-1, which is the most potent driver of fibrosis in the transforming growth factor beta (“TGF-β”) family of ligands,” he said. Jasbir S. Seehra. , Ph.D., Chairman and CEO of Keros. “We believe these data further validate that KER-012 has the potential to treat not only PAH but also other inflammatory and fibrotic diseases of the heart and lung.”

RKER-012 improved cardiopulmonary function in a rat model of PAH.

  • Improvement in cardiopulmonary function in a rat model of pulmonary arterial hypertension observed with RKER-012, a novel type II activin receptor ligand trap, was associated with reduced markers of inflammation and fibrosis in the right ventricle.

Keros combined administration of SUGEN5416, a vascular endothelial growth factor 1/2 receptor tyrosine kinase inhibitor, with exposure to chronic hypoxia to induce PAH in adult rats. RKER-012 was tested in this SUGEN/hypoxia (“SH”) rat model of PAH. SH-treated adult rats received vehicle or 10 mg/kg RKER-012 twice weekly for three weeks. Rats maintained under normal oxygen conditions (“normoxic controls”) received vehicle alone.

  • Consistent with the development of heart and lung failure, vehicle-treated SH rats exhibited increases in Fulton’s index (p≤0.0001), which measures right ventricular (“RV”) enlargement and systolic pulmonary arterial pressure (” sPAP”) (p ≤0.0001) relative to normoxic controls. In SH rats, RKER-012 treatment significantly attenuated the increase in Fulton index (p≤0.001) and prevented an increase in sPAP (p≤0.0001) compared to vehicle treatment.

  • RV from vehicle-treated SH rats exhibited significant increases in gene expression of several known drivers of inflammation compared to normoxic controls. Treatment with RKER-012 prevented the increase of these markers in the RV of SH rats.

  • Fibrosis biomarker expression was elevated in the RV of vehicle-treated SH rats compared to normoxic controls. Relative to vehicle-treated SH rats, RKER-012-treated SH rats had significantly reduced expression of most of these fibrosis biomarkers.

About KER-012
KER-012 is designed to bind to and inhibit the signaling of TGF-β ligands that promote smooth muscle hypertrophy and fibrosis, including activin A, activin B, and myostatin (GDF8). Keros believes that KER-012 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. KER-012 is being developed for the treatment of PAH and for the treatment of cardiovascular disorders associated with cardiac hypertrophy.

About Keros Therapeutics, Inc.
Keros is a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of novel therapies for patients suffering from hematologic, pulmonary and cardiovascular disorders with high unmet medical need. Keros is a leader in understanding the role of the TGF-β family of proteins, which are master regulators of red blood cell and platelet production, as well as the growth, repair, and maintenance of a number of tissues, including blood vessels and the heart tissue. . Keros’ lead protein therapeutic candidate, KER-050, is being developed for the treatment of low blood counts or cytopenias, including anemia and thrombocytopenia, in patients with myelodysplastic syndrome and in patients with myelofibrosis. Keros’ lead small molecule product candidate, KER-047, is being developed for the treatment of functional iron deficiency. Keros’ third product candidate, KER-012, is being developed for the treatment of pulmonary arterial hypertension and for the treatment of cardiovascular disorders associated with cardiac hypertrophy.

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 “believes”, “more” and “potential”, or similar expressions, are intended to identify forward-looking statements. Examples of these forward-looking statements include statements about: Keros’ expectations regarding its growth, strategy, progress, and the design, goals, and timing of its clinical trials for KER-012; and the potential of KER-012 to treat PAH and other inflammatory and fibrotic diseases of the heart and lungs. 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’s ability to raise additional funds to complete the development and any commercialization of its product candidates; Keros’ dependence on the success of its main product candidates, KER-050 and KER-047; that Keros may delay in starting, enrolling or completing any clinical trial; competition from third parties that are developing products for similar uses; Keros’s ability to obtain, maintain and protect its intellectual property; Keros’ reliance on third parties in connection with manufacturing, clinical trials, and preclinical studies; and risks related to the impact on Keros’ business of the COVID-19 pandemic or similar public health crisis.

These and other risks are described in more detail 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 with the SEC on November 3, 2022, and its other documents subsequently filed or provided to the SEC. All forward-looking statements contained in this press release speak only as of the date they are 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 they are made.

Investor contact:
deepankar roy
droy@kerostx.com
213-268-1878

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