 |
8 Diseases |  |
4 Trials |
|
4 Trials |  |
310 News |  |
| «1234» |
- | seladelpar (MBX-8025) / CymaBay
Journal: Editorial: The evolving paradigms and treatments for primary biliary cholangitis. (Pubmed Central) - Dec 28, 2023
No abstract available
- | seladelpar (MBX-8025) / CymaBay
Journal: Seladelpar treatment reduces interleukin-31 and pruritus in patients with primary biliary cholangitis. (Pubmed Central) - Dec 20, 2023
Seladelpar decreased serum IL-31 and bile acids in PBC patients. The reductions of IL-31 and bile acids correlated closely with each other and pruritus improvement suggesting a mechanism to explain seladelpar's anti-pruritic effects.
- ||| Livdelzi (seladelpar) / Gilead
Trial completion date, Trial primary completion date: AFFIRM: Seladelpar in Subjects With Primary Biliary Cholangitis (PBC) and Compensated Cirrhosis (clinicaltrials.gov) - Dec 10, 2023
P3, N=192, Recruiting, Sponsor: CymaBay Therapeutics, Inc.
- ||| Livdelzi (seladelpar) / Gilead
Trial completion date, Trial primary completion date: IDEAL: Intended to Determine the Effects of Seladelpar on Normalization of Alkaline Phosphatase Levels in Subjects With Primary Biliary Cholangitis (PBC) and an Incomplete Response or Intolerance to Ursodeoxycholic Acid (UDCA) (clinicaltrials.gov) - Dec 7, 2023
P3, N=75, Recruiting, Sponsor: CymaBay Therapeutics, Inc.
- seladelpar (MBX-8025) / CymaBay
EFFICACY AND SAFETY OF SELADELPAR IN PATIENTS WITH PRIMARY BILIARY CHOLANGITIS IN THE RESPONSE TRIAL: A PHASE 3 INTERNATIONAL, RANDOMIZED, PLACEBO-CONTROLLED STUDY () - Nov 11, 2023 - Abstract #AASLD2023AASLD_2812;
P3
In this placebo-controlled pivotal trial of patients with PBC and incomplete response or intolerance to UDCA, seladelpar 10 mg for 12 months resulted in rapid, statistically significant and durable improvements in markers of cholestasis and liver injury, and improved pruritus. Seladelpar appeared overall safe and well tolerated through Month 12.
- | seladelpar (MBX-8025) / CymaBay
Journal: Open-label, clinical trial extension: Two-year safety and efficacy results of seladelpar in patients with primary biliary cholangitis. (Pubmed Central) - Oct 31, 2023
P3
Seladelpar was safe, and markedly improved biochemical markers of cholestasis and liver injury in patients with PBC. These effects were maintained or improved throughout the second year.
- | Ocaliva (obeticholic acid) / Intercept, seladelpar (MBX-8025) / CymaBay
Journal, Biopsy: Liver biopsy for assessment of suspected drug-induced liver injury in metabolic dysfunction-associated steatohepatitis clinical trials: Expert consensus from the Liver Forum. (Pubmed Central) - Oct 25, 2023
These effects were maintained or improved throughout the second year. Although there are no pathognomonic features, histologic evaluation of suspected DILI during MASH clinical trials may alter patient management, define the pattern and severity of injury, detect findings that favour a diagnosis of DILI versus MASH progression, identify prognostic features, characterise the clinicopathological phenotype of DILI, and/or define lesions that influence decisions about trial discontinuation and further development of the drug.
- ||||| Livdelzi (seladelpar) / Gilead
Trial completion: RESPONSE: Response to Seladelpar in Subjects With Primary Biliary Cholangitis (PBC) and an Inadequate Control to or an Intolerance to Ursodeoxycholic Acid (UDCA) (clinicaltrials.gov) - Sep 30, 2023
P3, N=193, Completed, Sponsor: CymaBay Therapeutics, Inc.
Although there are no pathognomonic features, histologic evaluation of suspected DILI during MASH clinical trials may alter patient management, define the pattern and severity of injury, detect findings that favour a diagnosis of DILI versus MASH progression, identify prognostic features, characterise the clinicopathological phenotype of DILI, and/or define lesions that influence decisions about trial discontinuation and further development of the drug. Active, not recruiting --> Completed
- |||||||| Livdelzi (seladelpar) / Gilead
New P3 trial: IDEAL: Intended to Determine the Effects of Seladelpar on Normalization of Alkaline Phosphatase Levels in Subjects With Primary Biliary Cholangitis (PBC) and an Incomplete Response or Intolerance to Ursodeoxycholic Acid (UDCA) (clinicaltrials.gov) - Sep 29, 2023
P3, N=75, Recruiting, Sponsor: CymaBay Therapeutics, Inc.
- |||||||| Livdelzi (seladelpar) / Gilead
New P3 trial: AFFIRM: Seladelpar in Subjects With Primary Biliary Cholangitis (PBC) and Compensated Cirrhosis (clinicaltrials.gov) - Sep 25, 2023
P3, N=192, Recruiting, Sponsor: CymaBay Therapeutics, Inc.
- | elafibranor (GFT505) / Ipsen, seladelpar (MBX-8025) / CymaBay, lanifibranor (IVA337) / Inventiva
Journal: Functional and Structural Insights into the Human PPAR?/?/? Targeting Preferences of Anti-NASH Investigational Drugs, Lanifibranor, Seladelpar, and Elafibranor. (Pubmed Central) - Aug 26, 2023
These results illustrate the highly variable PPAR?/?/? activation profiles and binding modes of these PPAR ligands that define their pharmacological actions.
- seladelpar (MBX-8025) / CymaBay
Baseline Characteristics and Risk Profiles of 1111 Patients with Primary Biliary Cholangitis (PBC) in Need of Second-Line Therapy (Exhibit Hall) - Jul 29, 2023 - Abstract #ACG2023ACG_4261;
activation profiles and binding modes of these PPAR ligands that define their pharmacological actions. In four clinical trials with seladelpar from 2015
- seladelpar (MBX-8025) / CymaBay
Seladelpar Treatment Resulted in Correlated Decreases in Serum IL-31 and Pruritus in Patients with Primary Biliary Cholangitis (PBC): Post-Hoc Results from the Phase 3 Randomized, Placebo-Controlled ENHANCE Study (West Ballroom B) - Jul 29, 2023 - Abstract #ACG2023ACG_228;
P3
4 had significantly higher baseline median [IQR] IL-31 compared to patients with pruritus NRS < 4 (7.6 pg/mL [1.2, 14.5] vs 1.2 pg/mL [0.3, 2.8], p < 0.0001). At baseline, IL-31 was also correlated with serum total bile acids (r = 0.54, p < 0.0001) and ALP (r = 0.44, p < 0.0001).
- seladelpar (MBX-8025) / CymaBay
Baseline characteristics and risk profiles of 1111 patients with primary biliary cholangitis (PBC) in need of second-line therapy (Poster Area) - Apr 12, 2023 - Abstract #EASLILC2023EASL_ILC_581;
At baseline, IL-31 was also correlated with serum total bile acids (r = 0.54, p < 0.0001) and ALP (r = 0.44, p < 0.0001). In four clinical trials with seladelpar from 2015
- seladelpar (MBX-8025) / CymaBay
Seladelpar treatment resulted in correlated decreases in serum IL-31 and pruritus in patients with primary biliary cholangitis (PBC): post-hoc results from the phase 3 randomized, placebo-controlled ENHANCE study (Poster Area) - Apr 12, 2023 - Abstract #EASLILC2023EASL_ILC_565;
P3
Reduction in serum IL-31 correlated with pruritus improvement. These results suggest that IL-31 may have a role in pruritus in patients with PBC.
- seladelpar (MBX-8025) / CymaBay
Novel Pathways implicated in the seladelpar-mediated reductions of established liver fibrosis are identified from RNA-SEQ data using plex search and two independent mouse pharmacology datasets (Poster Area) - Apr 12, 2023 - Abstract #EASLILC2023EASL_ILC_479;
The results identified several pathways to investigate for their role in the reduction of fibrosis by seladelpar observed in mice. Understanding the roles of these pathways will assist in our understanding of the relevance of mechanisms for human disease.
- | Livdelzi (seladelpar) / Gilead
Trial completion date, Trial primary completion date: An Open-Label Study Following Oral Dosing of Seladelpar to Subjects With Primary Biliary Cholangitis (PBC) and Hepatic Impairment (HI) (clinicaltrials.gov) - Mar 28, 2023
P1, N=24, Recruiting, Sponsor: CymaBay Therapeutics, Inc.
Understanding the roles of these pathways will assist in our understanding of the relevance of mechanisms for human disease. Trial completion date: Mar 2023 --> Sep 2023 | Trial primary completion date: Jan 2023 --> Sep 2023
- || Review, Journal: PPAR agonists for the treatment of primary biliary cholangitis: Old and new tales. (Pubmed Central) - Jan 24, 2023
Ursodeoxycholic Acid (UDCA) is the standard of care treatment, Obeticholic Acid (OCA) has been approved as second-line therapy for those non responder or intolerant to UDCA...Bezafibrate, the most evaluated, is currently used in clinical practice in combination with UDCA in referral centers...Testing new therapeutic opportunities in PBC is challenging due to its low prevalence and slow progression. However, new drugs including PPAR agonists, are currently under investigation and should be considered for at-risk PBC patients.
- Update on clinical management of Primary Biliary Cirrhosis (3F Plenary Hall) - Dec 18, 2022 - Abstract #APASL2023APASL_237;
Novel PPAR agonists for PBC including elafibranor (PPAR-ad), saroglitazar (PPARa/g), and seladelpar(PPARd) showed a favorable biochemical response in phase 2 clinical trials. Lastly, RCT of linerixibat (an ileal bile acid transporter inhibitor) in PBC patients showed improvement in pruritus severity.
- || linerixibat (GSK2330672) / GSK, seladelpar (MBX-8025) / CymaBay, aldafermin (NGM282) / NGM Biopharma
Retrospective data, Review: Efficacy and safety of pharmacological interventions for pruritus in primary biliary cholangitis: A systematic review and meta-analysis. (Pubmed Central) - Nov 8, 2022
UDCA, bezafibrate, OCA, rifampicin, NGM282 and others may improve blood γ-glutamyl transpeptidase (γ-GGT) (p < 0.05), but due to the high heterogeneity and the limitation of research samples, a clear conclusion cannot be drawn...Due to the heterogeneity in the published studies, based on the present review, we cannot explicitly recommend any specific drug for the treatment of PBC-related pruritus. Systematic Review Registration: link-https://osf.io/2g8ya, identifier 10.17605/OSF.IO/2G8YA.
- seladelpar (MBX-8025) / CymaBay
COMBINATION TREATMENTS OF AN IBAT INHIBITOR AND VARIOUS PPAR ISOFORM AGONISTS INDUCE DISTINCT CHANGES IN LIVER BIOCHEMISTRIES IN THE MDR2-/- MOUSE MODEL OF SCLEROSING CHOLANGITIS () - Oct 23, 2022 - Abstract #AASLD2022AASLD_2285;
The combination therapy of IBATi and PPARδ agonist shows the most promise as a combination in this mouse model of SC. Further preclinical investigations may help to better understand the mechanisms underlying the synergy and potential adverse effects and to guide use in clinical trials.
- seladelpar (MBX-8025) / CymaBay
SELADELPAR IMPROVED THE LIPID PROFILE OF PATIENTS WITH PRIMARY BILIARY CHOLANGITIS (PBC): RESULTS FROM PHASE 2 AND 3 CLINICAL STUDIES () - Oct 23, 2022 - Abstract #AASLD2022AASLD_2284;
P2, P3
Treatment with seladelpar resulted in significant reductions in TC, LDL-C and TG in PBC patients, without meaningful changes in HDL-C. These results suggest that seladelpar treatment in patients with PBC and dyslipidemia may improve lipid profiles, in addition to markers of cholestasis and pruritus.
- seladelpar (MBX-8025) / CymaBay
SELADELPAR, A PPAR-DELTA AGONIST, IMPROVES INFLAMMATORY LIPID MEDIATORS IN THE SERUM METABOLOME IN PATIENTS WITH PRIMARY BILIARY CHOLANGITIS (PBC) () - Oct 23, 2022 - Abstract #AASLD2022AASLD_2256;
P3
Seladelpar treatment in patients with PBC resulted in broad changes in serum metabolites, many of which are downstream of known effects of PPARδ activation. This new detailed map of metabolomic changes sheds light on the effects of PPARδ activation and suggests potential mechanisms for investigation by which seladelpar improves measures of cholestasis and liver function in patients with PBC.
- seladelpar (MBX-8025) / CymaBay
EFFECTS OF SINGLE AND MULTIPLE DOSES IN MICE OF THE SELECTIVE PPARDELTA AGONIST SELADELPAR ON DIURNAL MARKERS OF BILE ACID SYNTHESIS. () - Oct 23, 2022 - Abstract #AASLD2022AASLD_1653;
The effects of seladelpar treatment on Cyp7a1 and C4, but not on FGF21, demonstrated a diurnal pattern consistent with feeding. These results suggest that the effectiveness of pharmacological inhibition of bile acid synthesis in cholestatic disease and its relation to food intake to may warrant further investigation.
- | seladelpar (MBX-8025) / CymaBay
Journal: Seladelpar in patients with primary biliary cholangitis: Need a closer look! (Pubmed Central) - Oct 20, 2022
These results suggest that the effectiveness of pharmacological inhibition of bile acid synthesis in cholestatic disease and its relation to food intake to may warrant further investigation. No abstract available
- | seladelpar (MBX-8025) / CymaBay
Journal: Response to letter from Mishra and Singh. (Pubmed Central) - Oct 20, 2022
No abstract available No abstract available
- | seladelpar (MBX-8025) / CymaBay
Journal: Seladelpar: an investigational drug for the treatment of early stage primary biliary cholangitis (PBC). (Pubmed Central) - Oct 19, 2022
Safety concerns around liver toxicity appear to have been addressed. With likely increasing evidence compared to existing off-label fibrates, seladelpar has potential as an attractive future second-line agent in PBC.
- | seladelpar (MBX-8025) / CymaBay
Journal: Prevalence and clinical significance of portal inflammation, portal plasma cells, interface hepatitis and biliary injury in liver biopsies from patients with non-alcoholic steatohepatitis. (Pubmed Central) - Sep 24, 2022
In 2019, CymaBay Therapeutics halted clinical trials of seladelpar (a PPARδ agonist) because initial end-of-treatment liver biopsies of patients with non-alcoholic steatohepatitis (NASH) showed concerning features of portal inflammation with plasma cells, interface hepatitis and focal bile duct abnormalities...NASH patients with advanced fibrosis had frequent and diffuse cholangiocyte changes, along with focal lymphocytic cholangitis and moderate to marked ductular reaction (score 3-4). Histopathological features of advanced NASH frequently include increased portal inflammation with plasma cells, interface hepatitis, cholangiocyte injury and prominent ductular reaction.
- |||| seladelpar (MBX-8025) / CymaBay
Clinical: Today is $CBAY's virtual analyst day! We’re looking forward to: • @KowdleyMd's presentation on the current treatment landscape & future goals for treating patients with #PBC • An update on our lead investigational drug, seladelpar • Live Q&A Learn more: https://t.co/MUma11vYn1 (Twitter) - Sep 22, 2022
- |||| Livdelzi (seladelpar) / Gilead
Enrollment closed, Trial completion date, Trial primary completion date: RESPONSE: Response to Seladelpar in Subjects With Primary Biliary Cholangitis (PBC) and an Inadequate Control to or an Intolerance to Ursodeoxycholic Acid (UDCA) (clinicaltrials.gov) - Sep 6, 2022
P3, N=193, Active, not recruiting, Sponsor: CymaBay Therapeutics, Inc.
Histopathological features of advanced NASH frequently include increased portal inflammation with plasma cells, interface hepatitis, cholangiocyte injury and prominent ductular reaction. Recruiting --> Active, not recruiting | Trial completion date: Mar 2023 --> Aug 2023 | Trial primary completion date: Nov 2022 --> Aug 2023
- | Preclinical, Journal: Combinations of an acetyl CoA carboxylase inhibitor with hepatic lipid modulating agents do not augment antifibrotic efficacy in preclinical models of NASH and fibrosis. (Pubmed Central) - Sep 3, 2022
In the choline-deficient high-fat diet rat model of advanced liver fibrosis, neither PPARα (Feno) nor THRβ (Res) agonism augmented the antifibrotic efficacy of ACCi. These data suggest that combination therapies targeting hepatocyte lipid metabolism may have beneficial effects on liver TG reduction; however, they may not be sufficient to drive fibrosis regression.
- | seladelpar (MBX-8025) / CymaBay
Journal: Selective PPARδ agonist seladelpar suppresses bile acid synthesis by reducing hepatocyte CYP7A1 via the fibroblast growth factor 21 signaling pathway. (Pubmed Central) - Jul 28, 2022
Finally, reduction of CYP7A1 expression by seladelpar was confirmed in primary human hepatocytes. In conclusion, we show that seladelpar reduces bile acid synthesis via an FGF21-dependent mechanism that signals at least partially through JNK to repress CYP7A1.
- || seladelpar (MBX-8025) / CymaBay
P2 data, Journal: A phase II, randomized, open-label, 52-week study of seladelpar in patients with primary biliary cholangitis. (Pubmed Central) - Jul 23, 2022
P2
Seladelpar demonstrated robust, dose-dependent, clinically significant, and durable improvements in biochemical markers of cholestasis and inflammation in patients with PBC at risk of disease progression. Seladelpar appeared safe and well tolerated and was not associated with any increase in pruritus.
- |||| seladelpar (MBX-8025) / CymaBay
From Dr. Schnabl at UCSD: 👉🏻PPARd agonist (seladelpar) ⬇️ Cyp7a1/BA synthesis via ⬆️ Fgf21 👉🏻Fgf21 signals through JNK to ⬇️ Cyp7a1 👉🏻Conserved mechanism for PPARd agonists 🌟mechanistic basis for seladelpar tx in PBC and NASH #ILC2022 (Twitter) - Jun 25, 2022
- seladelpar (MBX-8025) / CymaBay
The selective PPAR-delta agonist seladelpar suppresses bile acid synthesis by reducing hepatocyte CYP7A1 through the FGF21 pathway (Capital Suite 17) - May 12, 2022 - Abstract #EASLILC2022EASL_ILC_2327;
Seladelpar reduces bile acid synthesis via an FGF21- dependent mechanism that signals, at least partially through JNK, to repress Cyp7a1. NAFLD Therapy
- seladelpar (MBX-8025) / CymaBay
SELADELPAR TREATMENT OF PATIENTS WITH PRIMARY BILIARY CHOLANGITIS (PBC) FOR 2 YEARS IMPROVES THE GLOBE PBC SCORE AND PREDICTS IMPROVED TRANSPLANT-FREE SURVIVAL (32 - San Diego Convention Center) - May 7, 2022 - Abstract #DDW2022DDW_6818;
P2, P3
1D). Conclusion : Seladelpar treatment over 2 years resulted in a sustained decrease in GLOBE score for patients with PBC that is associated with a predicted improvement in transplant-free survival.
- Ocaliva (obeticholic acid) / Intercept, seladelpar (MBX-8025) / CymaBay
TREATMENT WITH SELADELPAR IN PATIENTS WITH PRIMARY BILIARY CHOLANGITIS (PBC) AND PRIOR EXPERIENCE WITH OBETICHOLIC ACID OR FIBRATES (Poster Hall - San Diego Convention Center) - Apr 25, 2022 - Abstract #DDW2022DDW_2862;
P2, P3
AE of pruritus was noted in 7%, 15%, and 18% in the 10 mg, 5 mg, and Pbo groups, respectively. Conclusion : In PBC pts with prior treatment with OCA or fibrates and ALP ≥ 1.67xULN, seladelpar appeared to be safe, well tolerated and showed meaningful and dose dependant improvement in biochemical markers of cholestasis.
- seladelpar (MBX-8025) / CymaBay
EFFICACY, SAFETY, AND TOLERABILITY OF SELADELPAR IN PATIENTS WITH COMPENSATED LIVER CIRRHOSIS DUE TO PRIMARY BILIARY CHOLANGITIS (PBC); A POOLED ANALYSIS OF PHASE 2 AND PHASE 3 STUDIES (Poster Hall - San Diego Convention Center) - Apr 25, 2022 - Abstract #DDW2022DDW_2859;
P2, P3
Efficacy, tolerability, and safety in patients with compensated cirrhosis were comparable to that of non-cirrhotic patients. Conclusion : Seladelpar appeared safe and was well tolerated and may provide an effective treatment option for patients with compensated liver cirrhosis due to PBC.
- Ocaliva (obeticholic acid) / Intercept, resmetirom (MGL-3196) / Madrigal Pharma, seladelpar (MBX-8025) / CymaBay
Comparative fibrosis-reducing activities of farnesoid X receptor (FXR), peroxisome-proliferator activated receptor delta (PPAR) and thyroid hormone receptor (THR) agonists in the carbon tetrachloride mouse model (Poster Area) - Mar 16, 2022 - Abstract #EASLILC2022EASL_ILC_1131;
The combination of total biochemical and histologic measurements are important to assess the topographic changes. Reduction of the PSR positive fibrotic cords between the veins is generally considered beneficial and readily observable in this model.
- seladelpar (MBX-8025) / CymaBay
Seladelpar treatment of patients with primary biliary cholangitis (PBC) for 2 years improves the GLOBE PBC score and predicts improved transplant-free survival (Meeting Point 3) - Mar 16, 2022 - Abstract #EASLILC2022EASL_ILC_780;
P3
Reduction of the PSR positive fibrotic cords between the veins is generally considered beneficial and readily observable in this model. Seladelpar treatment over 2 years resulted in a sustained decrease in GLOBE score for patients with PBC that is associated with a predicted improvement in transplant-free survival.
- || seladelpar (MBX-8025) / CymaBay
Clinical, Journal: Seladelpar Improved Measures of Pruritus, Sleep, and Fatigue and Decreased Serum Bile Acids in Patients with Primary Biliary Cholangitis. (Pubmed Central) - Mar 3, 2022
Seladelpar treatment over 2 years resulted in a sustained decrease in GLOBE score for patients with PBC that is associated with a predicted improvement in transplant-free survival. Seladelpar treatment for 1 year led to consistent improvement in both symptom burden and biochemical response suggesting its potential as a single agent to address two key unmet needs in PBC patients.
- ||||| seladelpar (MBX-8025) / CymaBay
Trial termination: A Study to Evaluate Seladelpar in Subjects With Nonalcoholic Steatohepatitis (NASH) (clinicaltrials.gov) - Jan 11, 2022
P2, N=181, Terminated, Sponsor: CymaBay Therapeutics, Inc.
Seladelpar treatment for 1 year led to consistent improvement in both symptom burden and biochemical response suggesting its potential as a single agent to address two key unmet needs in PBC patients. Completed --> Terminated; unexpected histological findings
- ||||| seladelpar (MBX-8025) / CymaBay
Clinical: We're excited to share the data from @DrCynthiaLevy’s presentation from this year’s #TLMdX mtg with @AASLDtweets. The presentation highlighted the effects of 3 months of seladelpar treatment in patients with cirrhosis and portal hypertension due to #PBC. https://t.co/8NkS33yqJB (Twitter) - Nov 18, 2021
- || Livdelzi (seladelpar) / Gilead
Enrollment open: An Open-Label Study Following Oral Dosing of Seladelpar to Subjects With Primary Biliary Cholangitis (PBC) and Hepatic Impairment (HI) (clinicaltrials.gov) - Oct 27, 2021
P1, N=24, Recruiting, Sponsor: CymaBay Therapeutics, Inc.
Completed --> Terminated; unexpected histological findings Not yet recruiting --> Recruiting
- seladelpar (MBX-8025) / CymaBay
[VIRTUAL] SELADELPAR REDUCES ESTABLISHED LIVER AND RENAL FIBROSIS IN THE NON-OBESE DIABETIC INFLAMMATION AND FIBROSIS (NIF) MOUSE MODEL () - Oct 21, 2021 - Abstract #AASLD2021AASLD_1561;
Reduction of fibrosis was apparent in specific anatomical locations within each organ with reductions in bridging fibrous septa in the liver and in noth the glomerular corpuscle and medulla in the kidney. Architecture specific analysis of fibrosis is more informative than overall measures, such as PSR area or hydroxyproline content .
- seladelpar (MBX-8025) / CymaBay
[VIRTUAL] EFFICACY AND SAFETY OF SELADELPAR IN PATIENTS WITH COMPENSATED CIRRHOSIS AND EVIDENCE OF PORTAL HYPERTENSION DUE TO PRIMARY BILIARY CHOLANGITIS (PBC) () - Oct 21, 2021 - Abstract #AASLD2021AASLD_1496;
P2, P3
Seladelpar treatment in PBC patients with CC and evidence of PHT resulted in meaningful improvements in biomarkers of cholestasis and hepatocellular injury . Seladelpar appeared safe and well tolerated, and warrants further evaluation .
- seladelpar (MBX-8025) / CymaBay
[VIRTUAL] LONG-TERM SAFETY AND EFFICACY OF SELADELPAR IN PATIENTS WITH PRIMARY BILIARY CHOLANGITIS (PBC): 2-YEAR RESULTS FROM A LONG-TERM STUDY () - Oct 7, 2021 - Abstract #AASLD2021AASLD_255;
P2, P3
Seladelpar appeared safe and well tolerated, and warrants further evaluation . Long- term treatment with seladelpar for 2 years appeared safe, was well tolerated, and resulted in reductions in biomarkers of cholestasis and hepatocellular injury with continued improvement observed between years 1 and 2 .
- ||| seladelpar (MBX-8025) / CymaBay
Seladelpar effective, safe in PBC with cirrhosis https://t.co/PYqCRn9GZ7 (Twitter) - Jul 13, 2021
- || Livdelzi (seladelpar) / Gilead
New P1 trial: An Open-Label Study Following Oral Dosing of Seladelpar to Subjects With Primary Biliary Cholangitis (PBC) and Hepatic Impairment (HI) (clinicaltrials.gov) - Jul 5, 2021
P1, N=24, Not yet recruiting, Sponsor: CymaBay Therapeutics, Inc.
- seladelpar (MBX-8025) / CymaBay
[VIRTUAL] Efficacy, safety, and tolerability of seladelpar in patients with compensated liver cirrhosis due to primary biliary cholangitis (PBC): a pooled analysis of phase 2 and phase 3 studies () - Jun 27, 2021 - Abstract #EASLILC2021EASL_ILC_1753;
P2, P3
Long- term treatment with seladelpar for 2 years appeared safe, was well tolerated, and resulted in reductions in biomarkers of cholestasis and hepatocellular injury with continued improvement observed between years 1 and 2 . Seladelpar appeared safe and was well tolerated and may provide an effective treatment option for patients with compensated liver cirrhosis due to PBC.