Winrevair (sotatercept)

To treat pulmonary arterial hypertension Drug Trials Snapshot

FDA Approval: 3/26/2024

Research Synopsis

  • Winrevair (sotatercept) is a soluble activin receptor type IIA IgG-Fc fusion protein, recently gaining attention for its potential in treating conditions like pulmonary arterial hypertension (PAH) and anemia.
  • Recent studies emphasize its safety profile, with manageable side effects reported in clinical trials.
  • Sotatercept shows promise in improving patients' health and quality of life, particularly for those suffering from PAH and skeletal-related issues in multiple myeloma.
  • Multiple clinical trials indicate that sotatercept enhances erythropoiesis, resulting in increased hemoglobin levels and red blood cell counts, suggesting its potential as a treatment for anemia.
  • The drug has demonstrated a dual effect by improving bone mass and density while also inhibiting bone resorption—key for managing osteolytic lesions in conditions like multiple myeloma.
  • Early-phase trials indicate potential efficacy in reducing bone lesions and tumor activity in multiple myeloma patients.
  • Sotatercept is being investigated for its role in various hematologic disorders, with ongoing research highlighting its potential as a first-in-class therapy targeting activin receptor pathways.
  • Through modulating erythropoiesis and bone metabolism, sotatercept could offer innovative treatment avenues for various malignancies and related bone diseases.
  • Continued research and clinical trials are crucial to fully establish sotatercept's efficacy, safety, and potential side effects in diverse patient populations.
  • Overall, sotatercept is positioned as a promising therapeutic agent with the potential to reshape treatment paradigms for anemia and bone-related complications in cancer patients.

Related articles

Research articles about Winrevair (sotatercept)

Winrevair (sotatercept)

A Belgian consensus on sotatercept for the treatment of pulmonary arterial hypertension.

London, UK

2 hours ago

1 Received

  • Pulmonary arterial hypertension (PAH) is a serious, rare illness that affects blood vessels in the lungs and can lead to heart failure and even death.
  • Current treatments work on three main areas but don't cure the disease, so researchers are looking for new options.
  • Sotatercept is a new medication that helps improve patients' health and quality of life, and it's been shown to be safe, though it can cause some side effects.

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Gateways to clinical trials.

London, UK

2 hours ago

1 Received

  • The text appears to be a comprehensive list of various pharmaceutical compounds and drug names, including both approved medications and experimental treatments.
  • It features a wide range of drug classes such as antivirals, anticancer agents, and others used in treating various medical conditions.
  • These compounds showcase advancements in medical research and therapy options across different therapeutic areas.

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Treatment with a soluble receptor for activin improves bone mass and structure in the axial and appendicular skeleton of female cynomolgus macaques (Macaca fascicularis).

London, UK

2 hours ago

1 Received

  • * In a follow-up study with female cynomolgus monkeys, those treated with ACE-011 showed significant increases in bone mineral density (BMD) and trabecular bone volume compared to the control group.
  • * The results suggest that ACE-011 could be a promising treatment for preventing or treating issues related to skeletal fragility in humans.

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Gateways to clinical trials.

London, UK

2 hours ago

1 Received

  • * Some notable examples include [90Y-DOTA-Tyr3]octreotate for cancer, Abatacept for autoimmune diseases, and Peginterferon alfa-2a for hepatitis.
  • * The list reflects a wide range of therapies, highlighting advancements in medical treatments across different diseases.

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A soluble activin receptor Type IIA fusion protein (ACE-011) increases bone mass via a dual anabolic-antiresorptive effect in Cynomolgus monkeys.

London, UK

2 hours ago

1 Received

  • Activin A is part of the TGF-beta superfamily and influences bone metabolism, with a study showing that a soluble form of the activin receptor type IIA (ActRIIA) fused to IgG can stimulate bone growth in mice.* -
  • In a study involving young female Cynomolgus monkeys, treatment with human ActRIIA-IgG1-Fc (ACE-011) resulted in significant increases in cancellous bone volume and bone formation rates, while decreasing osteoclast activity.* -
  • ACE-011 demonstrated a dual effect by enhancing bone formation and reducing bone resorption, indicating its potential as a therapeutic agent for preventing bone loss.*

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Sotatercept, a soluble activin receptor type 2A IgG-Fc fusion protein for the treatment of anemia and bone loss.

London, UK

2 hours ago

1 Received

  • - Sotatercept (ACE-011), developed by Acceleron Pharma with Celgene Corp, is a protein designed to block activin, potentially impacting conditions like cancer and osteoporosis-related bone loss.
  • - Preclinical studies on its mouse version, RAP-011, show promise, especially regarding cancer and bone health, leading to further investigations in humans.
  • - Phase I trials indicated higher hematocrit in postmenopausal women, while Phase II trials in multiple myeloma patients showed early signs of reduced bone lesions and potential tumor activity; ongoing trials are assessing its effects on anemia and possible side effects.

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Advances in imaging and the management of myeloma bone disease.

London, UK

2 hours ago

1 Received

  • Osteolytic disease is a significant issue in multiple myeloma, potentially leading to severe skeletal-related events (SREs), with conventional radiography being the primary method for evaluating bone disease.
  • Whole-body MRI is recommended for patients with normal radiography and is essential for staging specific conditions like solitary plasmacytoma; it is also preferred for assessing possible cord compression.
  • Bisphosphonates, particularly pamidronate and zoledronic acid, are crucial in managing myeloma-related bone disease, offering survival benefits but necessitating caution due to potential side effects, with newer agents like denosumab and combination therapies being investigated for future treatment advancements.*

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[Current approaches in multiple myeloma and other cancer-related bone diseases].

London, UK

2 hours ago

1 Received

  • Multiple myeloma (MM) is a common blood cancer in older adults, often leading to bone damage or loss, which is typically diagnosed using standard radiography, while CT and MRI are utilized for more sensitive detection.
  • Bisphosphonates like zoledronate and pamidronate are key treatments for the bone-related issues linked with MM, often used alongside potent anti-myeloma drugs such as bortezomib and lenalidomide.
  • Ongoing research is exploring new bone-targeting agents, like denosumab and anti-sclerostin antibodies, to further improve management of bone disease in myeloma, with findings potentially applicable to other cancers that cause similar bone complications.

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Circulating activin-A is elevated in patients with advanced multiple myeloma and correlates with extensive bone involvement and inferior survival; no alterations post-lenalidomide and dexamethasone therapy.

London, UK

2 hours ago

1 Received

  • Activin-A is a protein linked to osteolytic disease in multiple myeloma, showing increased levels in both newly diagnosed and relapsed patients compared to healthy controls.
  • Patients with higher activin-A levels faced more advanced myeloma stages and had worse survival outcomes, indicating its potential as a prognostic marker.
  • The treatment combination of lenalidomide and dexamethasone did not significantly lower activin-A levels, suggesting that using activin-A antagonists like sotatercept could be beneficial in myeloma therapies.

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Activin receptor antagonists for cancer-related anemia and bone disease.

London, UK

2 hours ago

1 Received

  • Antagonists of activin receptor signaling show promise for treating cancer-related conditions like anemia and bone diseases associated with cancers such as multiple myeloma and solid tumors.
  • The review discusses how dysregulation in activin receptor pathways is linked to anemia, osteolysis, and metastatic bone disease, and highlights the development of activin receptor antagonists in a clinical setting.
  • Sotatercept, a novel receptor fusion protein, has demonstrated positive effects in increasing red blood cells and inhibiting tumor growth in both preclinical and early clinical studies, indicating its potential as a first-in-class therapy for cancer-related anemia and bone diseases.

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Stromal cell-mediated inhibition of erythropoiesis can be attenuated by Sotatercept (ACE-011), an activin receptor type II ligand trap.

London, UK

2 hours ago

1 Received

  • * ACE-011 does not impact the direct differentiation of human CD34(+) cells but can influence bone marrow stromal cells, revealing a complex interaction affecting erythropoiesis.
  • * The study found that conditioned media from ACE-011-treated stromal cells enhanced the production of red blood cells, suggesting that modifying the bone marrow microenvironment could help treat anemia in clinical settings.

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Signal transduction inhibitors in treatment of myelodysplastic syndromes.

London, UK

2 hours ago

1 Received

  • - Myelodysplastic syndromes (MDS) are blood disorders leading to low blood counts and can evolve into leukemia; however, the primary issues for patients usually stem from chronic low counts rather than the transformation.
  • - Traditional treatments for MDS have mixed results and significant side effects, particularly for older patients, which creates a need for targeted therapies that can improve blood counts and address bone marrow failure.
  • - Various targeted strategies are being researched, including inhibitors for specific signaling pathways (like p38 MAPK and TGF-β), which have shown promising results in clinical trials, highlighting the potential for more effective treatments for MDS.

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Multiple-dose, safety, pharmacokinetic, and pharmacodynamic study of sotatercept (ActRIIA-IgG1), a novel erythropoietic agent, in healthy postmenopausal women.

London, UK

2 hours ago

1 Received

  • Sotatercept is a new protein treatment designed to trap activin receptor type IIA (ActRIIA) ligands, originally created to help with bone health but found to enhance red blood cell production (erythropoiesis).
  • In a study involving 31 healthy postmenopausal women, sotatercept was administered in various doses every 28 days and was found to be generally safe, causing significant increases in hemoglobin and red blood cell counts for up to 4 months.
  • The results indicated a dose-dependent effect, with potential uses being explored for treating anemia and enhancing bone mineral density in other clinical settings.

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Management of bone disease in multiple myeloma.

London, UK

2 hours ago

1 Received

  • - Osteolytic bone disease is a major complication of multiple myeloma, leading to serious health issues, and bisphosphonates (especially zoledronic acid) are the primary treatment option to manage this problem.
  • - Patients with ongoing myeloma should continue receiving bisphosphonates for effective management, and other treatments like radiotherapy and surgery may be used for specific severe cases.
  • - Recent research into the mechanisms of myeloma bone disease has led to promising new treatments like denosumab, sotatercept, and romosozumab, which are currently being tested in clinical trials.

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An activin receptor IIA ligand trap corrects ineffective erythropoiesis in β-thalassemia.

London, UK

2 hours ago

1 Received

  • The study investigates the mechanisms underlying ineffective erythropoiesis in β-thalassemia and finds that RAP-011, a specific ligand trap, can improve anemia and limit iron overload in affected mice.
  • Increased levels of growth differentiation factor 11 (GDF11) in thalassemic subjects contribute to oxidative stress and hinder proper red blood cell maturation, suggesting its involvement in the disease.
  • Targeting GDF11 could enhance the differentiation of red blood cells by inducing the death of immature erythroblasts, indicating that ActRIIA ligand traps might offer a new therapeutic approach for managing β-thalassemia.

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Targeting a new regulator of erythropoiesis to alleviate anemia.

London, UK

2 hours ago

1 Received

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Modulators of erythropoiesis: emerging therapies for hemoglobinopathies and disorders of red cell production.

London, UK

2 hours ago

1 Received

  • - New compounds like JAK2 inhibitors and transforming growth factor β-like molecules could significantly change how β-thalassemia and similar disorders are treated.
  • - While these treatments show promise, there’s a need for careful optimization to avoid potential risks, particularly off-target immune suppression associated with JAK2 inhibitors.
  • - Additionally, the use of soluble ligand traps that target activin receptor IIA and B lacks clear understanding of their mechanisms, highlighting the need for more research.

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Sotatercept in patients with osteolytic lesions of multiple myeloma.

London, UK

2 hours ago

1 Received

  • This phase IIa study assessed the safety and tolerability of sotatercept in patients with newly diagnosed and relapsed multiple myeloma, comparing it to a placebo.
  • Patients were given either sotatercept or placebo alongside a standard treatment called MPT for a total of four cycles.
  • The results indicated that while sotatercept was generally well-tolerated, 58% of those treated experienced severe adverse events, but it also showed promising effects on bone metabolism and increased hemoglobin levels.

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An activin receptor IIA ligand trap promotes erythropoiesis resulting in a rapid induction of red blood cells and haemoglobin.

London, UK

2 hours ago

1 Received

  • Sotatercept (ACE-011) is a recombinant protein that inhibits activin and TGF-β superfamily members, showing promise in increasing red blood cell (RBC) count and hemoglobin in clinical trials.
  • In animal studies, RAP-011 (the mouse version of ACE-011) leads to rapid increases in hematocrit and RBC production, linked to stimulation of bone marrow precursors and increased erythropoietin levels.
  • Research indicates that RAP-011 may counteract the inhibitory effects of certain TGF-β ligands on late-stage red blood cell development, providing insights for developing sotatercept as a treatment for anemia.

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