Rezurock (belumosudil) / Romeck Pharma, Sanofi 
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 0 Diseases   12 Trials   12 Trials   593 News 


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  • ||||||||||  FDA event, Review, Journal:  Properties of FDA-approved small molecule protein kinase inhibitors: a 2022 update. (Pubmed Central) -  Apr 8, 2022   
    All of the FDA-approved drugs are orally effective with the exception of netarsudil, temsirolimus, and the newly approved trilaciclib. This review summarizes the physicochemical properties of all 68 FDA-approved small molecule protein kinase inhibitors including lipophilic efficiency and ligand efficiency.
  • ||||||||||  Rezurock (belumosudil) / Kadmon, Romeck Pharma, Jakafi (ruxolitinib) / Novartis, Incyte
    FDA event, Journal:  Three FDA-approved therapies for chronic GVHD. (Pubmed Central) -  Apr 5, 2022   
    After four decades of testing multiple therapeutic approaches, the drugs ibrutinib, belumosudil and ruxolitinib were FDA-approved for cGVHD in the last four years. Here we put a spotlight on their mechanisms of action, the studies that led to approval, and their future role in cGVHD.
  • ||||||||||  Sarclisa (isatuximab-irfc) / Sanofi
    Trial completion date, Trial primary completion date, Combination therapy:  Isatuximab in Combination With Novel Agents in RRMM - Master Protocol (clinicaltrials.gov) -  Mar 23, 2022   
    P1/2,  N=66, Recruiting, 
    Here we put a spotlight on their mechanisms of action, the studies that led to approval, and their future role in cGVHD. Trial completion date: Feb 2026 --> Sep 2026 | Trial primary completion date: Feb 2026 --> Sep 2026
  • ||||||||||  Rezurock (belumosudil) / Romeck Pharma, Sanofi
    Enrollment closed:  KD025 in Subjects With Diffuse Cutaneous Systemic Sclerosis (clinicaltrials.gov) -  Feb 7, 2022   
    P2,  N=60, Active, not recruiting, 
    Trial completion date: Feb 2022 --> Jun 2022 | Trial primary completion date: Jan 2022 --> May 2022 Recruiting --> Active, not recruiting
  • ||||||||||  Rezurock (belumosudil) / Kadmon, Romeck Pharma
    Review, Journal:  Belumosudil: First Approval. (Pubmed Central) -  Jan 27, 2022   
    Clinical development for systemic sclerosis is ongoing in the USA. This article summarizes the milestones in the development of belumosudil leading to this first approval for the treatment of cGVHD.
  • ||||||||||  Rezurock (belumosudil) / Romeck Pharma, Sanofi
    Trial completion date:  KD025 in Subjects With Diffuse Cutaneous Systemic Sclerosis (clinicaltrials.gov) -  Jan 25, 2022   
    P2,  N=60, Recruiting, 
    This article summarizes the milestones in the development of belumosudil leading to this first approval for the treatment of cGVHD. Trial completion date: Jun 2023 --> Feb 2023
  • ||||||||||  Rezurock (belumosudil) / Kadmon, Romeck Pharma
    Correlation of Patient-Reported Outcomes with Clinical Organ Responses: Data from the Belumosudil Chronic Graft-Versus-Host Disease Studies (Salt Palace Convention Center Hall A) -  Jan 9, 2022 - Abstract #TCTASTCTCIBMTR2022TCT_ASTCT_CIBMTR_1148;    
    P2, P2a
    In particular, there is excellent correlation of the skin, mouth, eye, upper GI, lung (clinical but not FEV1%), and overall measures. The poor correlation with joints, esophagus, lower GI and FEV1% suggests that for these response measures, PROs may be measuring different manifestations, or the clinician or PRO measures may be inadequately sensitive to change in cGVHD.
  • ||||||||||  Rezurock (belumosudil) / Romeck Pharma, Sanofi
    Trial completion date, Trial primary completion date:  KD025 in Subjects With Diffuse Cutaneous Systemic Sclerosis (clinicaltrials.gov) -  Jan 5, 2022   
    P2,  N=60, Recruiting, 
    We identified distinct prognostic factors for FFS that can inform risk stratification and prognostication of patients being treated with belumosudil. Trial completion date: May 2022 --> Jun 2023 | Trial primary completion date: Dec 2021 --> Jun 2022
  • ||||||||||  Rezurock (belumosudil) / Kadmon, Romeck Pharma
    Journal:  ROCK2 inhibition attenuates profibrogenic immune cell function to reverse thioacetamide-induced liver fibrosis. (Pubmed Central) -  Dec 20, 2021   
    We show that ROCK2 mediates increased IL-17 production, antibody production, and macrophage dysregulation, which together drive fibrogenesis in a model of chemical-induced liver fibrosis. Therefore, in this study, we not only highlight the therapeutic potential of ROCK2 targeting in chronic liver disease but also provide previously undocumented insights into our understanding of cellular and molecular pathways driving the liver fibrosis pathology.
  • ||||||||||  Rezurock (belumosudil) / Kadmon, Romeck Pharma
    Journal:  AHFS®first Release™. (Pubmed Central) -  Dec 16, 2021   
    Therefore, in this study, we not only highlight the therapeutic potential of ROCK2 targeting in chronic liver disease but also provide previously undocumented insights into our understanding of cellular and molecular pathways driving the liver fibrosis pathology. No abstract available
  • ||||||||||  Rezurock (belumosudil) / Kadmon, Romeck Pharma
    Journal:  ROCK2 Inhibition With Belumosudil (KD025) for the Treatment of Chronic Graft-Versus-Host Disease. (Pubmed Central) -  Nov 25, 2021   
    Belumosudil treatment resulted in a high ORR and overall survival rate and demonstrated quality-of-life improvements, CS dose reductions, and limited toxicity. Data from the study indicated that belumosudil may prove to be an effective therapy for patients with treatment-refractory cGVHD.
  • ||||||||||  Rezurock (belumosudil) / Kadmon, Romeck Pharma
    Budget Impact Analysis of Belumosudil for Chronic Graft-Versus-Host Disease Treatment in the United States (GWCC - Hall B5, Level 1) -  Nov 5, 2021 - Abstract #ASH2021ASH_3497;    
    In each of the three scenarios examined, focusing on patients receiving existing branded agents in 3L/4L+ cGHVD, belumosudil demonstrated 0.9-1.9% in overall and $0.01 in PMPM savings, likely driven by the favorable safety profile of belumosudil reducing AEs and HCRU. The model indicates that belumosudil may provide an alternative to existing cGVHD treatments while also offering cost savings to a US health plan.
  • ||||||||||  Rezurock (belumosudil) / Romeck Pharma, Sanofi
    Trial completion date, Trial primary completion date:  A Study to Evaluate the Safety, Tolerability, and Activity of KD025 in Subjects With Chronic Graft Versus Host Disease (clinicaltrials.gov) -  Oct 7, 2021   
    P2a,  N=88, Active, not recruiting, 
    A randomized pivotal study (AGAVE-201) has started enrolling a similar pt population, evaluating doses of 1 mg/kg Q2W and 3mg/kg Q4W, along with a lower dose of 0.3mg/kg Q2W. Trial completion date: Sep 2021 --> Feb 2022 | Trial primary completion date: Aug 2021 --> Jan 2022
  • ||||||||||  Rezurock (belumosudil) / Romeck Pharma, Sanofi
    Trial completion, Trial completion date, Trial primary completion date:  A Phase I Study to Evaluate the Taste of Belumosudil Oral Suspensions & Assess Relative Bioavailability (clinicaltrials.gov) -  Sep 16, 2021   
    P1,  N=30, Completed, 
    Trial completion date: Sep 2021 --> Feb 2022 | Trial primary completion date: Aug 2021 --> Jan 2022 Recruiting --> Completed | Trial completion date: Feb 2022 --> Jul 2021 | Trial primary completion date: Dec 2021 --> Jul 2021
  • ||||||||||  Rezurock (belumosudil) / Kadmon, Romeck Pharma
    Review, Journal:  ROCK2, a critical regulator of immune modulation and fibrosis has emerged as a therapeutic target in chronic graft-versus-host disease. (Pubmed Central) -  Sep 15, 2021   
    Consistent with its anti-inflammatory and antifibrotic activities, belumosudil has demonstrated efficacy in clinical studies, resulting in an overall response rate of >70% in patients with cGVHD who failed 2 to 5 prior lines of systemic therapy. In summary, selective ROCK2 inhibition has emerged as a promising novel therapeutic approach for treating cGVHD and other immunologic diseases with unique mechanisms of action, targeting both immune imbalance and detrimental fibrotic responses.
  • ||||||||||  Rezurock (belumosudil) / Kadmon, Romeck Pharma
    Journal:  ROCK2-Specific Inhibitor KD025 Suppresses Adipocyte Differentiation by Inhibiting Casein Kinase 2. (Pubmed Central) -  Sep 8, 2021   
    By contrast, CK2 inhibitor CX-4945 and ROCK inhibitor fasudil did not show such cross-reactivity...Other well-known CK2 inhibitors DMAT and quinalizarin inhibited effectively the differentiation of 3T3-L1 cells. Taken together, the results of this study confirmed that KD025 inhibits ROCK2 and CK2, and that the inhibitory effect on adipocyte differentiation is through the inhibition of CK2.