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- ||||| KD025Â / Kadmon, Romeck Pharma, KD-025 CAR T-cells / KAEDI
Clinical: The selective ROCK2 inhibitor KD025 induced clinical responses in approximately two-thirds of patients with chronic graft-versus-host disease, including complete responses in 3 patients, explains @DrCCutler of @DanaFarber #GVHD https://t.co/GHpfss0QYm (Twitter) - Feb 25, 2020
- ||||| KD025Â / Kadmon, Romeck Pharma, KD-025 CAR T-cells / KAEDI
Clinical, Late-breaking abstract: @DrCCutler is a rockstar on his own and presented the eponymous study in chronic a#GVHD in #LBA at #TCTM20. KD025 is an oral inhibitor of ROCK2. Two thirds of patients achieved a good response including in fibrosis. Early CU (<6 months at this point). (Twitter) - Feb 23, 2020
- ||| KD025Â / Kadmon, Romeck Pharma, KD-025 CAR T-cells / KAEDI
LBA2 #TCTM20 #Cutler KD025 for treatment of chronic GVHD ( #ROCKstar study ) (Twitter) - Feb 23, 2020
- |||| KD025Â / Kadmon, Romeck Pharma, KD-025 CAR T-cells / KAEDI
#TCTM20 @DrCCutler shows interim analysis of Ph2 trial of KD025 for refractory chronic #GVHD; overall response rate of ~65% (Twitter) - Feb 23, 2020
- |||| KD025Â / Kadmon, Romeck Pharma, Jakafi oral (ruxolitinib) / Novartis, Incyte, KD-025 CAR T-cells / KAEDI
Clinical: Strategies for chronic #GVHD management in children, Ruxolitinib and KD025 look promising #TCTM20 (Twitter) - Feb 20, 2020
- belumosudil (KD025Â ) / Kadmon, Romeck Pharma
[VIRTUAL] INTERIM ANALYSIS OF KD025-213: A PHASE 2, RANDOMIZED, MULTICENTER STUDY TO EVALUATE THE EFFICACY AND SAFETY OF KD025 IN SUBJECTS WITH CGVHD (THE ROCKSTAR STUDY) (ePoster Area) - Feb 8, 2020 - Abstract #EBMT2020EBMT_2129;
P2, P2a
ORR was consistent across key subgroups. KD025 has been generally well tolerated.
- belumosudil (KD025Â ) / Kadmon, Romeck Pharma
[VIRTUAL] KD025 FOR PATIENTS WITH CHRONIC GRAFT-VERSUS-HOST DISEASE (CGVHD) - LONG-TERM FOLLOW-UP OF A PHASE 2A STUDY (KD025-208) (ePoster Area) - Feb 8, 2020 - Abstract #EBMT2020EBMT_2123;
P2a
KD025 was well tolerated, allowing pts to remain on treatment and realize benefits of sustained therapy. Clinical Trial Registry: NCT02841995 http://clinicaltrials.gov/ct@/show/NCT02841995
- KD025Â / Kadmon, Romeck Pharma
Interim Analysis of KD025-213: A Phase 2, Randomized, Multicenter Study to Evaluate the Efficacy and Safety of KD025 in Subjects with Chronic Graft Versus Host Disease (cGVHD) after at Least 2 Prior Lines of Systemic Therapy (The ROCKstar Study; NCT03640481) (World Center Marriott - Palms: Royal) - Jan 14, 2020 - Abstract #TCTASTCTCIBMTR2020TCT_1407;
P2, P2a
ORR was consistent across key subgroups. KD025 has been generally well tolerated.
- KD025Â / Kadmon, Romeck Pharma, KD-025 CAR T-cells / KAEDI
KD025 for Patients with Chronic Graft-Versus-Host Disease (cGVHD) – Long-Term Follow-up of a Phase 2a Study (KD025-208) (World Center Marriott - Palms & Cypress Foyers) - Jan 14, 2020 - Abstract #TCTASTCTCIBMTR2020TCT_1061;
Durable and clinically meaningful responses have been seen across all 3 cohorts. KD025 was well tolerated, with sustained responses and encouraging FFS in patients with advanced cGVHD.
- || Rezurock (belumosudil) / Romeck Pharma, Sanofi
Enrollment open: KD025 Hepatic Impairment Study With Normal Hepatic Function and Subjects With Varying Degrees of Hepatic Impairment (clinicaltrials.gov) - Jan 8, 2020
P1, N=40, Recruiting, Sponsor: Kadmon Corporation, LLC
KD025 was well tolerated, with sustained responses and encouraging FFS in patients with advanced cGVHD. Not yet recruiting --> Recruiting
- | KD025Â / Kadmon, Romeck Pharma
Kadmon and Meiji Collaborate to Form JV for the Development and Commercialization of KD025 in Japan https://t.co/69ECfGrofi (Twitter) - Dec 27, 2019
- KD025Â / Kadmon, Romeck Pharma, KD-025 CAR T-cells / KAEDI
Neuronal ROCK2 Plays Important Role in Ischemic Stroke: GSK-3beta and Tau Signaling Pathways (Hall H) - Dec 21, 2019 - Abstract #ISC2020ISC_1317;
We investigated the pharmacological effect of selective ROCK2 inhibition by selective ROCK2 inhibitor, KD025 and the genetic effect using neuronal specific ROCK2 knockout (ROCK2Eno2-/-) mice. These findings indicate that neuronal ROCK2 plays important role in ischemic stroke via GSK-3β and Tau signaling pathways and inhibition of neuronal specific ROCK2 may have therapeutic benefits in ischemic stroke.
- | fluoxetine / generics
Journal: Rho-kinase inhibition has antidepressant-like efficacy and expedites dendritic spine pruning in adolescent mice. (Pubmed Central) - Dec 2, 2019
ROCK inhibition had rapid antidepressant-like effects in adolescent mice, and its efficacy was comparable to ketamine and fluoxetine...Further, vmPFC-specific shRNA-mediated reduction of ROCK2, the dominant ROCK isoform in the brain, had antidepressant-like consequences. We cautiously suggest that ROCK inhibitors may have therapeutic potential for adolescent-onset depression.
- || Rezurock (belumosudil) / Romeck Pharma, Sanofi
New P1 trial: KD025 Hepatic Impairment Study With Normal Hepatic Function and Subjects With Varying Degrees of Hepatic Impairment (clinicaltrials.gov) - Nov 17, 2019
P1, N=40, Not yet recruiting, Sponsor: Kadmon Corporation, LLC
- | KD025Â / Kadmon
Do you think KD025 will get approved or not? (Twitter) - Nov 12, 2019
- KD025Â / Kadmon
KD025 for Patients with Chronic Graft-Versus-Host Disease (cGVHD) – Long-Term Follow-up of a Phase 2a Study (KD025-208) (W230, Level 2 (Orange County Convention Center)) - Nov 7, 2019 - Abstract #ASH2019ASH_5184;
Durable and clinically meaningful responses have been observed across all 3 cohorts. KD025 was well tolerated, allowing pts to remain on treatment and realize potential benefits of sustained therapy.
- | Rezurock (belumosudil) / Romeck Pharma, Sanofi
Trial initiation date: KD025 in Subjects With Diffuse Cutaneous Systemic Sclerosis (clinicaltrials.gov) - Sep 18, 2019
P2, N=60, Recruiting, Sponsor: Kadmon Corporation, LLC
KD025 was well tolerated, allowing pts to remain on treatment and realize potential benefits of sustained therapy. Initiation date: Apr 2019 --> Jul 2019
- | Rezurock (belumosudil) / Romeck Pharma, Sanofi
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) - Sep 15, 2019
P2a, N=88, Active, not recruiting, Sponsor: Kadmon Corporation, LLC
Initiation date: Apr 2019 --> Jul 2019 Trial primary completion date: Aug 2019 --> Jan 2020
- | KD025Â / Kadmon
Journal: Role of age, Rho-kinase 2 expression, and G protein-mediated signaling in the myogenic response in mouse small mesenteric arteries. (Pubmed Central) - Sep 12, 2019
MT development in SMAs occurs through a G /PLC/Ca -dependent pathway, and is maintained via ROCK2-mediated Ca sensitization. Increased MT at mature adulthood can be explained by increased ROCK2 expression/activity.
- | Rezurock (belumosudil) / Romeck Pharma, Sanofi
Enrollment closed: ROCKstar: Efficacy and Safety of KD025 in Subjects With cGVHD After At Least 2 Prior Lines of Systemic Therapy (clinicaltrials.gov) - Sep 9, 2019
P2, N=126, Active, not recruiting, Sponsor: Kadmon Corporation, LLC
Increased MT at mature adulthood can be explained by increased ROCK2 expression/activity. Recruiting --> Active, not recruiting
- | fasudil / Generic Mfg., KD025Â / Kadmon
Journal: Spreading depolarizations trigger caveolin-1-dependent endothelial transcytosis. (Pubmed Central) - Aug 23, 2019
Recruiting --> Active, not recruiting Our data elucidate the mechanisms by which CSDs lead to transient BBB disruption, with diagnostic and therapeutic implications for migraine and brain injury.
- | Rezurock (belumosudil) / Romeck Pharma, Sanofi
Trial completion, Trial completion date: KD025-108: Human Absorption, Distribution and Metabolism Study (hAME) [14C]-KD025 (clinicaltrials.gov) - Aug 21, 2019
P1, N=5, Completed, Sponsor: Kadmon Corporation, LLC
Our data elucidate the mechanisms by which CSDs lead to transient BBB disruption, with diagnostic and therapeutic implications for migraine and brain injury. Not yet recruiting --> Completed | Trial completion date: Aug 2019 --> May 2019
- | Rezurock (belumosudil) / Romeck Pharma, Sanofi
Enrollment closed: A 2-Part, Phase 2 Open-label and Crossover Study of Belumosudil for Treatment of Idiopathic Pulmonary Fibrosis (clinicaltrials.gov) - Aug 14, 2019
P2, N=76, Active, not recruiting, Sponsor: Kadmon Corporation, LLC
Not yet recruiting --> Completed | Trial completion date: Aug 2019 --> May 2019 Recruiting --> Active, not recruiting
- | Rezurock (belumosudil) / Romeck Pharma, Sanofi
Trial completion: Drug-drug Interaction Between Belumosudil, Itraconazole, Rifampicin, Rabeprazole, and Omeprazole in Healthy Volunteers (clinicaltrials.gov) - Aug 14, 2019
P1, N=73, Completed, Sponsor: Kadmon Corporation, LLC
Recruiting --> Active, not recruiting Recruiting --> Completed
- ||| Rezurock (belumosudil) / Romeck Pharma, Sanofi
Trial completion, Enrollment change: A Phase 2, Double-blind, Placebo-controlled Study of the Efficacy and Safety of Belumosudil in Subjects With Moderate/Severe Chronic Plaque Psoriasis (clinicaltrials.gov) - Jun 12, 2019
P2, N=110, Completed, Sponsor: Kadmon Corporation, LLC
Recruiting --> Completed Recruiting --> Completed | N=180 --> 110
- |||| Rezurock (belumosudil) / Romeck Pharma, Sanofi
New P2 trial: KD025 in Subjects With Diffuse Cutaneous Systemic Sclerosis (clinicaltrials.gov) - Apr 17, 2019
P2, N=60, Recruiting, Sponsor: Kadmon Corporation, LLC
- || Rezurock (belumosudil) / Romeck Pharma, Sanofi
New P1 trial: KD025-108: Human Absorption, Distribution and Metabolism Study (hAME) [14C]-KD025 (clinicaltrials.gov) - Apr 9, 2019
P1, N=6, Not yet recruiting, Sponsor: Kadmon Corporation, LLC
- | KD025 / Kadmon
Journal: The selective ROCK2 inhibitor KD025 reduces IL-17 secretion in human peripheral blood mononuclear cells independent of IL-1 and IL-6. (Pubmed Central) - Apr 5, 2019
Using anti-CD3/CD28 activation of the TCR, KD025 similarly suppressed IL-17 independent of a reduction in IL-1?. Thus, ROCK2 directly reduces IL-17 secretion independent of endogenous IL-1 and IL-6 and supports selective ROCK2 inhibitors for treatment of IL-17-driven inflammatory diseases.
- ||| Rezurock (belumosudil) / Romeck Pharma, Sanofi
Enrollment change, Trial initiation date, Trial primary completion date: A 2-Part, Phase 2 Open-label and Crossover Study of Belumosudil for Treatment of Idiopathic Pulmonary Fibrosis (clinicaltrials.gov) - Feb 18, 2019
P2, N=81, Recruiting, Sponsor: Kadmon Corporation, LLC
Thus, ROCK2 directly reduces IL-17 secretion independent of endogenous IL-1 and IL-6 and supports selective ROCK2 inhibitors for treatment of IL-17-driven inflammatory diseases. N=36 --> 81 | Initiation date: Mar 2016 --> Jun 2016 | Trial primary completion date: Mar 2017 --> Jul 2020
- || Rezurock (belumosudil) / Romeck Pharma, Sanofi
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) - Feb 8, 2019
P2a, N=88, Active, not recruiting, Sponsor: Kadmon Corporation, LLC
N=36 --> 81 | Initiation date: Mar 2016 --> Jun 2016 | Trial primary completion date: Mar 2017 --> Jul 2020 Trial primary completion date: Dec 2018 --> Aug 2019
- ||| Rezurock (belumosudil) / Romeck Pharma, Sanofi
Enrollment open: ROCKstar: Efficacy and Safety of KD025 in Subjects With cGVHD After At Least 2 Prior Lines of Systemic Therapy (clinicaltrials.gov) - Dec 13, 2018
P2, N=126, Recruiting, Sponsor: Kadmon Corporation, LLC
Trial primary completion date: Dec 2018 --> Aug 2019 Not yet recruiting --> Recruiting
- | Rezurock (belumosudil) / Romeck Pharma, Sanofi
Enrollment change, Trial completion date, Trial primary completion date: Drug-drug Interaction Between Belumosudil, Itraconazole, Rifampicin, Rabeprazole, and Omeprazole in Healthy Volunteers (clinicaltrials.gov) - Oct 15, 2018
P1, N=78, Recruiting, Sponsor: Kadmon Corporation, LLC
Not yet recruiting --> Recruiting N=40 --> 78 | Trial completion date: Jul 2018 --> Jun 2019 | Trial primary completion date: Jul 2018 --> Mar 2019
- | Rezurock (belumosudil) / Romeck Pharma, Sanofi
Enrollment closed, Enrollment change, 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 9, 2018
P2a, N=88, Active, not recruiting, Sponsor: Kadmon Corporation, LLC
N=40 --> 78 | Trial completion date: Jul 2018 --> Jun 2019 | Trial primary completion date: Jul 2018 --> Mar 2019 Recruiting --> Active, not recruiting | N=48 --> 88 | Trial primary completion date: Aug 2018 --> Dec 2018
- | Rezurock (belumosudil) / Romeck Pharma, Sanofi
New P2 trial: ROCKstar: Efficacy and Safety of KD025 in Subjects With cGVHD After At Least 2 Prior Lines of Systemic Therapy (clinicaltrials.gov) - Aug 20, 2018
P2, N=126, Not yet recruiting, Sponsor: Kadmon Corporation, LLC
- || Rezurock (belumosudil) / Romeck Pharma, Sanofi
New P1 trial: Drug-drug Interaction Between Belumosudil, Itraconazole, Rifampicin, Rabeprazole, and Omeprazole in Healthy Volunteers (clinicaltrials.gov) - May 21, 2018
P1, N=40, Recruiting, Sponsor: Kadmon Corporation, LLC
- | belumosudil (KD025) / Kadmon, Romeck Pharma
Journal: Cutting Edge: Selective Oral ROCK2 Inhibitor Reduces Clinical Scores in Patients with Psoriasis Vulgaris and Normalizes Skin Pathology via Concurrent Regulation of IL-17 and IL-10. (Pubmed Central) - Sep 21, 2017
We observed significant reductions of IL-17 and IL-23, but not IL-6 and TNF-α, whereas IL-10 levels were increased in peripheral blood of clinical responders after 12 wk of treatment with KD025. Collectively, these data demonstrate that an orally available selective ROCK2 inhibitor downregulates the Th17-driven autoimmune response and improved clinical symptoms in psoriatic patients via a defined molecular mechanism that involves concurrent modulation of cytokines without deleterious impact on the rest of the immune system.
- | belumosudil (KD025) / Kadmon, Romeck Pharma
Journal: Targeted Rho-associated kinase 2 (ROCK2) inhibition decreases clinical and immune pathology of murine and human chronic GVHD through Stat3-dependent mechanism. (Pubmed Central) - Jul 15, 2017
The therapeutic potential of targeted ROCK2 inhibition in the clinic was solidified further by human data demonstrating the KD025 inhibits the secretion of IL-21, IL-17, and IFNγ along with decreasing phosphorylated STAT3 and reduced protein expression of IRF4 and BCL6 in human peripheral blood mononuclear cells purified from active cGVHD patients. Together these data highlight the potential of targeted ROCK2 inhibition for clinical cGVHD therapy.
- ||| Rezurock (belumosudil) / Romeck Pharma, Sanofi
Enrollment change: A Phase 2, Double-blind, Placebo-controlled Study of the Efficacy and Safety of Belumosudil in Subjects With Moderate/Severe Chronic Plaque Psoriasis (clinicaltrials.gov) - Jun 26, 2017
P2, N=180, Recruiting, Sponsor: Kadmon Corporation, LLC
Together these data highlight the potential of targeted ROCK2 inhibition for clinical cGVHD therapy. N=150 --> 180
- | Rezurock (belumosudil) / Romeck Pharma, Sanofi
Enrollment open: A Study to Evaluate the Safety, Tolerability, and Activity of KD025 in Subjects With Chronic Graft Versus Host Disease (clinicaltrials.gov) - Sep 19, 2016
P2a, N=48, Recruiting, Sponsor: Kadmon Corporation, LLC
N=150 --> 180 Not yet recruiting --> Recruiting
- |||| Rezurock (belumosudil) / Romeck Pharma, Sanofi
Enrollment open: A Phase 2, Double-blind, Placebo-controlled Study of the Efficacy and Safety of Belumosudil in Subjects With Moderate/Severe Chronic Plaque Psoriasis (clinicaltrials.gov) - Sep 6, 2016
P2, N=150, Recruiting, Sponsor: Kadmon Corporation, LLC
Not yet recruiting --> Recruiting Not yet recruiting --> Recruiting
- ||||| Rezurock (belumosudil) / Romeck Pharma, Sanofi
New P2 trial: A Phase 2, Double-blind, Placebo-controlled Study of the Efficacy and Safety of Belumosudil in Subjects With Moderate/Severe Chronic Plaque Psoriasis (clinicaltrials.gov) - Aug 2, 2016
P2, N=150, Not yet recruiting, Sponsor: Kadmon Corporation, LLC
- | Rezurock (belumosudil) / Romeck Pharma, Sanofi
New P2a trial: A Study to Evaluate the Safety, Tolerability, and Activity of KD025 in Subjects With Chronic Graft Versus Host Disease (clinicaltrials.gov) - Jul 23, 2016
P2a, N=48, Not yet recruiting, Sponsor: Kadmon Corporation, LLC
- | Rezurock (belumosudil) / Romeck Pharma, Sanofi
Trial completion: Phase 2, Open-label, Study of KD025 in Subjects With Psoriasis Vulgaris Who Failed First-line Therapy (clinicaltrials.gov) - May 4, 2016
P2, N=38, Completed, Sponsor: Kadmon Corporation, LLC
Not yet recruiting --> Recruiting Active, not recruiting --> Completed
- | Rezurock (belumosudil) / Romeck Pharma, Sanofi
Enrollment open: A 2-Part, Phase 2 Open-label and Crossover Study of Belumosudil for Treatment of Idiopathic Pulmonary Fibrosis (clinicaltrials.gov) - Mar 31, 2016
P2, N=36, Recruiting, Sponsor: Kadmon Corporation, LLC
Active, not recruiting --> Completed Not yet recruiting --> Recruiting
- | Rezurock (belumosudil) / Romeck Pharma, Sanofi
Enrollment closed: Phase 2, Open-label, Study of KD025 in Subjects With Psoriasis Vulgaris Who Failed First-line Therapy (clinicaltrials.gov) - Mar 15, 2016
P2, N=38, Active, not recruiting, Sponsor: Kadmon Corporation, LLC
Not yet recruiting --> Recruiting Recruiting --> Active, not recruiting
- | Rezurock (belumosudil) / Romeck Pharma, Sanofi
New P2 trial: A 2-Part, Phase 2 Open-label and Crossover Study of Belumosudil for Treatment of Idiopathic Pulmonary Fibrosis (clinicaltrials.gov) - Feb 23, 2016
P2, N=36, Not yet recruiting, Sponsor: Kadmon Corporation, LLC
- Rezurock (belumosudil) / Romeck Pharma, Sanofi
Trial primary completion date: Phase 2, Open-label, Study of KD025 in Subjects With Psoriasis Vulgaris Who Failed First-line Therapy (clinicaltrials.gov) - Jan 17, 2016
P2, N=36, Recruiting, Sponsor: Kadmon Corporation, LLC
Recruiting --> Active, not recruiting Trial primary completion date: Dec 2015 --> Mar 2016
- | Rezurock (belumosudil) / Romeck Pharma, Sanofi
Trial completion: Bioavailability of Belumosudil (KD025) in Healthy Male Subjects (clinicaltrials.gov) - Jan 15, 2016
P1, N=24, Completed, Sponsor: Kadmon Corporation, LLC
Trial primary completion date: Dec 2015 --> Mar 2016 Active, not recruiting --> Completed
- Rezurock (belumosudil) / Romeck Pharma, Sanofi
Enrollment closed: Bioavailability of Belumosudil (KD025) in Healthy Male Subjects (clinicaltrials.gov) - Nov 21, 2015
P1, N=24, Active, not recruiting, Sponsor: Kadmon Corporation, LLC
Active, not recruiting --> Completed Recruiting --> Active, not recruiting
- | Rezurock (belumosudil) / Romeck Pharma, Sanofi
New P1 trial: Bioavailability of Belumosudil (KD025) in Healthy Male Subjects (clinicaltrials.gov) - Sep 23, 2015
P1, N=24, Recruiting, Sponsor: Kadmon Corporation, LLC