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  • ||||||||||  Review, Journal:  Small Molecule Therapy for Inflammatory Bowel Disease: JAK Inhibitors and S1PR Modulators (Pubmed Central) -  Aug 23, 2024   
    Ozanimod and etrasimod are S1PRMs approved for the treatment of UC, but they can cause side effects such as bradycardia, conduction disorder, and macular edema. Overall, JAK inhibitors and S1PRMs offer significant benefits in managing IBD, although their potential side effects require careful monitoring.
  • ||||||||||  Velsipity (etrasimod) / Pfizer
    Efficacy and Safety Profile of Etrasimod Was Not Impacted by Baseline Disease Activity: A Post Hoc Analysis of the ELEVATE UC Program (Exhibit Hall E) -  Aug 20, 2024 - Abstract #ACG2024ACG_4855;    
    P3
    However, following the maintenance period, for both clinical response and remission among induction phase responders, a significantly greater proportion of ETR pts achieved clinical response and remission compared to OZN (relative risk 1.19 (95% CI, 1.06-1.31), p< 0.05 and 1.34 (95% CI, 1.11-1.55), p< 0.05 respectively) at 52 weeks. Of the 743 pts in this analysis, 525 (70.7%) and 218 (29.3%) had a BL MMS of 5
  • ||||||||||  Velsipity (etrasimod) / Pfizer
    Pregnancy Outcomes in the Etrasimod Clinical Program (Exhibit Hall E) -  Aug 20, 2024 - Abstract #ACG2024ACG_4841;    
    Of the 743 pts in this analysis, 525 (70.7%) and 218 (29.3%) had a BL MMS of 5 In total, 2,091 unique patients were exposed to etrasimod in clinical trials; 593 (28.4%) were females of childbearing age (aged 16
  • ||||||||||  Velsipity (etrasimod) / Pfizer
    Efficacy of Etrasimod in Patients With Ulcerative Colitis: A Post Hoc Analysis Based on Baseline Endoscopic Subscore (Exhibit Hall E) -  Aug 20, 2024 - Abstract #ACG2024ACG_4834;    
    P3
    At Wk 12, significantly greater proportions of patients receiving etrasimod vs placebo achieved clinical remission and secondary endpoints in the ES of 2 subgroup ( p < 0.001), and all endpoints ( p < 0.001) except endoscopic normalization ( p = 0.083) in the ES of 3 subgroup (Figure; Table). At Wk 52, clinical remission ( p < 0.001) and secondary endpoints ( p < 0.05), except symptomatic remission ( p = 0.058) and clinical response ( p = 0.057), were achieved in the ES of 2 subgroup, and all endpoints in the ES of 3 subgroup ( p < 0.001; Figure; Table).
  • ||||||||||  Velsipity (etrasimod) / Pfizer
    The Impact of Etrasimod on the Transcriptome in Colon Biopsies Using RNA-Seq: Data from ELEVATE UC 52 and ELEVATE UC 12 Phase 3 Clinical Trials (Exhibit Hall E) -  Aug 20, 2024 - Abstract #ACG2024ACG_1406;    
    P3
    There were significant reductions in T cell subsets (CD4+, CD8+, helper [Th]1 and Th17), plasma/mature B cell subsets, and innate immune cell subsets (monocytes, macrophages, dendritic cells, and natural killer cells) in the colon of pts receiving etrasimod (false discovery rate [FDR] < 0.05]); significant changes were not seen among pts receiving PBO. There were also reductions in inflammatory fibroblasts and increases in epithelial cells in the colon of pts receiving etrasimod but not PBO.
  • ||||||||||  Velsipity (etrasimod) / Pfizer
    Low Incidence of Macular Edema in Patients in the Etrasimod Clinical Program (Exhibit Hall E) -  Aug 20, 2024 - Abstract #ACG2024ACG_1353;    
    In the Placebo-controlled UC cohort, Macular edema was reported in two patients (0.3%; IR 0.70) receiving etrasimod 2 mg QD (one patient with long-term corticosteroid use in ELEVATE UC 52 and one patient with prior uveitis in ELEVATE UC 12, which was not considered clinically significant by the investigator) and one patient (0.3%; IR 0.84) receiving placebo (ELEVATE UC 12). In the All UC cohort, one patient (0.1%; IR 0.13) receiving etrasimod 2 mg QD during the ELEVATE UC OLE reported two events of Cystoid macular edema (Table).
  • ||||||||||  Velsipity (etrasimod) / Pfizer
    Etrasimod for Moderately to Severely Active Crohn's Disease: Results From the Extension Period of a Phase 2 Study (Exhibit Hall E) -  Aug 20, 2024 - Abstract #ACG2024ACG_1352;    
    P3
    For the TT analysis, 14.3% and 19.5% of patients receiving 2 mg or 3 mg etrasimod, respectively, achieved endoscopic response, 28.6% and 34.1% achieved CDAI remission, and 19.0% and 36.6% achieved PRO2 remission at W52 (Table). Among W14 responders (RO), 23.1% and 33.3% of patients receiving 2 mg or 3 mg etrasimod, respectively, achieved endoscopic response, 46.2% and 54.2% achieved CDAI remission, and 30.8% and 58.3% achieved PRO2 remission at W52 (Table).
  • ||||||||||  tetracycline / Generic mfg.
    Journal, Adverse events:  Safety profiles of Tetracycline-class drugs: a pharmacovigilance analysis of the FAERS database. (Pubmed Central) -  Aug 19, 2024   
    Three new antibiotics, tigecycline, omadacycline, and eravacycline, approved within the past 18?years, and represent a new era in the use of tetracyclines...Patients aged 12-18 and treatment with minocycline are risk factors for thyroid adverse events(12-18: OR?=?10.727 [7.113-16.177], p?<?0.0001; minocycline: OR?=?17.025 [10.475-27.678], p?<?0.0001).Second-generation tetracycline and third-generation tetracycline ADR patterns differed...This study investigated adverse events highly associated with tetracyclines treatment, which provided basic evidence for further research on tetracyclines-related adverse events for children. However, the safety of third-generation tetracycline in children requires additional validation through a large-scale prospective study.
  • ||||||||||  zetomipzomib (KZR-616) / Kezar
    Enrollment closed:  A Study of Zetomipzomib (KZR-616) in Patients With Autoimmune Hepatitis (PORTOLA) (clinicaltrials.gov) -  Aug 19, 2024   
    P2,  N=24, Active, not recruiting, 
    This retrospective, real-world analysis suggests potential clinical utility in UGT1A1 testing for patients receiving sacituzumab, but future trials are needed to confirm the association between genotypes and treatment outcomes. Recruiting --> Active, not recruiting
  • ||||||||||  Trodelvy (sacituzumab govitecan-hziy) / Gilead, Enhertu (fam-trastuzumab deruxtecan-nxki) / Daiichi Sankyo, AstraZeneca, Padcev (enfortumab vedotin-ejfv) / Astellas, Pfizer
    Biomarker, Trial completion date, Trial initiation date, Trial primary completion date, Metastases:  Personalized Antibody-Drug Conjugate Therapy Based on RNA and Protein Testing for the Treatment of Advanced or Metastatic Solid Tumors (The ADC MATCH Screening and Treatment Trial) (clinicaltrials.gov) -  Aug 16, 2024   
    P2,  N=500, Not yet recruiting, 
    Subsequent removal of the oxo group facilitated the synthesis of cyclopenta[b]indol-3-ylacetic acid through a series of reactions, including methanolysis, indoline oxidation, and hydrolysis. Trial completion date: Oct 2024 --> Oct 2027 | Initiation date: Jun 2024 --> Dec 2024 | Trial primary completion date: Oct 2024 --> Oct 2027
  • ||||||||||  Cosela (trilaciclib) / G1 Therap
    Trial completion, Metastases:  Trilaciclib in Patients Receiving Sacituzumab Govitecan-hziy for Triple Negative Breast Cancer (clinicaltrials.gov) -  Aug 12, 2024   
    P2,  N=30, Completed, 
    Doxycycline was associated with psychiatric side effects; minocycline presented in thyroid and skin tissue-associated tumors; abnormal signals were detected with eravacycline in the blood system. Active, not recruiting --> Completed
  • ||||||||||  tetracycline / Generic mfg.
    Journal:  Enhancing outer membrane permeability of tetracycline antibiotics in P. aeruginosa using TOB-CIP conjugates. (Pubmed Central) -  Aug 12, 2024   
    The structure-activity relationship investigation indicates that the flexible hydrophobic C12 carbon-chain linker in TOB-CIP conjugate 1a is an optimal potentiator of tetracyclines against tetracycline-resistant and -susceptible strains of P. aeruginosa. Furthermore, conjugate 1a consistently synergized with the 3rd generation tetracycline, eravacycline, in P. aeruginosa PAO1 in the presence of up to 25% fetal bovine serum (FBS).
  • ||||||||||  Trodelvy (sacituzumab govitecan-hziy) / Gilead
    Journal:  Sacituzumab govitecan in heavily pretreated, platinum-resistant high grade serous ovarian cancer. (Pubmed Central) -  Aug 7, 2024   
    P2
    Sacituzumab govitecan may represent a treatment option for platinum-resistant/recurrent HGSOC that have previously failed prior lines of chemotherapy. Clinical trials with sacituzumab govitecan in platinum-resistant ovarian cancer patients are currently ongoing (https://classic.clinicaltrials.gov/ct2/show/NCT06028932).
  • ||||||||||  Velsipity (etrasimod) / Pfizer
    Trial completion date, Real-world evidence, Real-world effectiveness, Real-world:  ENDEAVOUR-UC: An Observational Study of Etrasimod in Adult Patients With Moderate to Severe Ulcerative Colitis (clinicaltrials.gov) -  Aug 5, 2024   
    P=N/A,  N=300, Not yet recruiting, 
    Clinical trials with sacituzumab govitecan in platinum-resistant ovarian cancer patients are currently ongoing (https://classic.clinicaltrials.gov/ct2/show/NCT06028932). Trial completion date: Feb 2028 --> Aug 2027
  • ||||||||||  Tarpeyo (budesonide) / Calliditas, Stada
    Review, Journal, Immunomodulating:  Insights on Nefecon (Pubmed Central) -  Aug 5, 2024   
    These studies demonstrated that Nefecon has a distinct pharmacokinetic profile from other budesonide products, allowing for targeted, localized action in the distal ileum. When considered alongside existing clinical trial data showing the effect of Nefecon on gut-associated biomarkers, available evidence indicates that Nefecon has a selective immunomodulatory mechanism of action and a direct disease-modifying effect in patients with IgAN, while having low systemic exposure and adverse effects.
  • ||||||||||  Trodelvy (sacituzumab govitecan-hziy) / Gilead
    Trial completion date, Trial primary completion date:  Testing Sacituzumab Govitecan Therapy in Patients With HER2-Negative Breast Cancer and Brain Metastases (clinicaltrials.gov) -  Aug 1, 2024   
    P2,  N=44, Recruiting, 
    The results indicate that SG demonstrates efficacy in mUC across Trop-2 expression levels. Trial completion date: Dec 2026 --> Dec 2028 | Trial primary completion date: Feb 2025 --> Dec 2027
  • ||||||||||  Invanz (ertapenem) / Merck (MSD), Xerava (eravacycline) / SOM Biotech, Ewha Womans University, PAION, Innoviva
    A RARE CASE OF LEUCONOSTOC GROWTH IN PLEURAL FLUID AND LACTOBACILLUS FROM A MEDIASTINAL ABSCESS (Convention Center Exhibit Hall: Poster Area 2) -  Jul 31, 2024 - Abstract #CHEST2024CHEST_5328;    
    This is the first case report to our knowledge to document Leuconostoc species growth from pleural fluid culture. Although these bacterial species are unfamiliar infections of pleural fluid and abscess, it is crucial to know how to navigate treatment, especially at hospitals in which susceptibility testing is not routinely performed.
  • ||||||||||  tetracycline / Generic mfg.
    Review, Journal:  Third-Generation Tetracyclines: Current Knowledge and Therapeutic Potential. (Pubmed Central) -  Jul 31, 2024   
    Additionally, we will explore their therapeutic potential, analyzing their primary indications of prescription, potential future uses, and non-antibiotic features. This review aims to provide valuable insights into the clinical applications of third-generation tetracyclines, thereby enhancing understanding and guiding optimal clinical use.
  • ||||||||||  Review, Journal, PD(L)-1 Biomarker, IO biomarker:  Antibody-Drug Conjugates to Promote Immune Surveillance: Lessons Learned from Breast Cancer. (Pubmed Central) -  Jul 27, 2024   
    Immune-checkpoint inhibitors (ICIs) also showed activity in selected BC subtypes, and two agents, pembrolizumab and atezolizumab, are currently approved for the treatment of triple-negative BC patients...Given this background, several clinical trials evaluated ADC-ICI combinations in BC patients, demonstrating promising outcomes with an overall manageable toxicity profile, and many studies are currently ongoing to confirm the efficacy and feasibility of this therapeutic approach. In the present review, we summarized the available evidence about the integration of ADCs and immunotherapy for the management of BC, emphasizing the need for further translational and clinical investigations to optimize this treatment strategy and elucidate predictive biomarkers, eventually improving patient outcomes.