Keros Therapeutics, Inc. operates as a clinical stage biopharmaceutical company. It focuses on the discovery, development and commercialization of novel treatments for patients suffering from hematological and musculoskeletal disorders with unmet medical need. The company was founded in 2015 and is headquartered in Lexington, MA.
相关临床试验
12
6 进行中
药物批准
0
批准总数
监管机构
0
监管机构数
成立时间
2015
进行中（未招募）
5
41.7%
已完成
1
8.3%
尚未招募
1
8.3%
招募中
2
16.7%
终止
1
8.3%
撤回
2
16.7%
暂无批准数据
- The global pulmonary arterial hypertension pipeline comprises over 55 companies developing 55+ therapeutic candidates across all clinical phases, representing significant industry investment in this rare disease. - Merck's WINREVAIR (sotatercept-csrk) demonstrated a 76% reduction in relative risk of major morbidity and mortality events in high-risk PAH patients during Phase 3 ZENITH trial results. - Recent regulatory milestones include FDA Fast Track designation for Cereno Scientific's CS1 and IND clearance for VASTHERA's VTB-10, highlighting accelerated development pathways for novel PAH therapies. - AllRock Bio secured $50 million in Series A funding to advance ROC-101, a first-in-class pan-ROCK inhibitor, into Phase 2 trials for PAH and pulmonary hypertension associated with interstitial lung disease.
- Keros Therapeutics received FDA orphan drug designation for KER-065 in August 2025, targeting Duchenne muscular dystrophy through selective inhibition of TGF-β ligands including myostatin and activin A. - The company reported initial top-line results from a phase I study in healthy volunteers in March 2025 and plans to initiate a phase II trial in DMD patients in Q1 2026. - KER-065 aims to address limitations of current glucocorticoid therapy by promoting muscle regeneration and strength while reducing side effects like muscle catabolism and bone loss. - The competitive DMD landscape includes established players like Sarepta Therapeutics with gene therapy Elevidys and PTC Therapeutics with corticosteroid treatments.
- Over 25 pharmaceutical companies are actively developing 30+ TGF-β inhibitors to address significant unmet needs in oncology and fibrosis where existing therapies show limited effectiveness. - Key pipeline advances include Keros Therapeutics initiating Phase III trials for elritercept in myelodysplastic syndromes and EpicentRx receiving FDA Fast Track designation for AdAPT-001 in soft tissue sarcoma. - Recent clinical milestones demonstrate promising efficacy across multiple indications, with companies like Isarna Therapeutics reporting positive Phase II results for retinal fibrosis treatment ISTH0036.
- AllRock Bio raised $50 million in Series A funding co-led by Versant Ventures and Westlake BioPartners to advance ROC-101, a first-in-class oral pan-ROCK inhibitor exclusively licensed from Sanofi. - ROC-101 targets pulmonary arterial hypertension and pulmonary hypertension with interstitial lung disease, conditions with five-year survival rates of 57% and 38% respectively. - Phase 1 data demonstrated favorable safety and tolerability with no associated hypotension, validating the pan-ROCK inhibition approach for addressing fundamental disease drivers. - The Phase 2a ROCSTAR clinical trial will evaluate ROC-101 in combination with standard of care and is expected to begin in late 2025.
- Keros Therapeutics announced that the U.S. FDA granted Orphan Drug designation to KER-065 for the treatment of Duchenne muscular dystrophy on August 20, 2025. - The designation provides potential benefits including tax credits for clinical testing, waiver of FDA application fees, and seven years of market exclusivity if approved. - KER-065 is a novel ligand trap designed to inhibit myostatin and activin A to increase muscle regeneration and strength in patients with neuromuscular diseases. - The company plans to advance KER-065 into a Phase 2 clinical trial for DMD patients, addressing a significant unmet medical need in this rare disease population.
- Keros Therapeutics has dosed the first patient in the Phase 3 RENEW clinical trial evaluating elritercept for transfusion-dependent anemia in myelodysplastic syndromes. - The milestone triggers a $10 million payment from Takeda under their global licensing agreement, which includes potential payments exceeding $1.1 billion. - The randomized, double-blind, placebo-controlled trial aims to evaluate elritercept's efficacy in reducing red blood cell transfusions in MDS patients. - Elritercept is an engineered ligand trap targeting TGF-β signaling pathways to treat cytopenias including anemia and thrombocytopenia.
- Elevation Oncology has agreed to be acquired by Concentra Biosciences, controlled by hedge fund Tang Capital Partners, for $0.36 per share in cash with additional contingent value rights. - The acquisition represents the latest example of investment firms targeting struggling biotech "zombies" worth less than their cash reserves for liquidation rather than strategic repositioning. - Elevation's lead cancer drug disappointed in clinical testing, forcing the company to shelve its program, lay off most staff, and trade below $1 per share for nearly a year. - The deal follows Tang Capital's previous acquisitions of struggling biotechs including Allakos, Jounce Therapeutics, and Kronos Bio through its liquidation-focused investment strategy.
- Keros Therapeutics has discontinued development of cibotercept (KER-012) for pulmonary arterial hypertension after observing dose-dependent pericardial effusions in the TROPOS Phase 2 trial. - The company halted all dosing in the trial following safety reviews that revealed higher incidence rates of pericardial effusions compared to placebo and existing PAH treatments. - No clinically meaningful improvements in pulmonary vascular resistance or 6-minute walk distance were observed, leading to complete program termination. - The company is reducing its workforce by 45% to 85 employees, expecting $17 million in annual cost savings while exploring alternative development strategies.
• KER-065 demonstrated favorable safety profile with no serious adverse events in Phase 1 trial, showing evidence of activin inhibition across multiple tissues of interest. • The novel ligand trap therapy showed promising biomarker changes including increased bone formation, fat mobilization, bone mineral density, and muscle mass, supporting its potential in treating DMD. • Keros plans to engage with regulatory authorities in Q3 2025 and aims to advance KER-065 into Phase 2 clinical trials for Duchenne muscular dystrophy by Q1 2026.
• Keros Therapeutics halted its Phase 2 TROPOS trial of cibotercept (KER-012) for pulmonary arterial hypertension (PAH) due to pericardial effusion adverse events. • The decision follows a previous halt of higher dose arms and now includes the 1.5 mg/kg and placebo arms, leading to early termination of the trial. • Topline data from all treatment arms will still be presented in Q2 2025, with patients monitored through end-of-trial visits. • Cibotercept, a TGF-β ligand inhibitor, aimed to improve pulmonary hemodynamics and exercise capacity in PAH patients but showed unexpected safety issues.
