- |||||||||| BXQ-350 / Bexion
Phase classification, Combination therapy, Metastases: ASIST: BXQ-350 in Newly Diagnosed Metastatic Colorectal Carcinoma (clinicaltrials.gov) - Aug 28, 2024 P1/2, N=195, Recruiting, Recruiting --> Active, not recruiting | N=22 --> 10 | Trial completion date: Dec 2024 --> Dec 2025 | Trial primary completion date: Dec 2023 --> Dec 2024 Phase classification: P1b/2 --> P1/2
- |||||||||| 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.
- |||||||||| Tysabri (natalizumab) / Biogen, Royalty
Journal: Experience in the management of pregnant patients with highly active multiple sclerosis in the Moscow region (Pubmed Central) - Aug 23, 2024 Prolongation of infusions to 30-34 weeks of pregnancy contributed to stabilization of the condition throughout the perinatal period. Discontinuation of FGL therapy at the onset of pregnancy increased the risk of repeated relapses of the disease, up to the development of inflammatory immune restoration syndrome during pregnancy and contributed to the increase in disability in the postpartum period.
- |||||||||| fingolimod / Generic mfg.
Trial completion, Trial completion date: Safety and Effectiveness of Generic Fingolimod (Sphingomod (clinicaltrials.gov) - Aug 23, 2024 P=N/A, N=30, Completed, Discontinuation of FGL therapy at the onset of pregnancy increased the risk of repeated relapses of the disease, up to the development of inflammatory immune restoration syndrome during pregnancy and contributed to the increase in disability in the postpartum period. Active, not recruiting --> Completed | Trial completion date: May 2024 --> Nov 2023
- |||||||||| Ponvory (ponesimod) / Juvise Pharma, Vanda
Targeting the pathogenic synergy of ceramide and S1P in Alzheimer (MCP Room N427) - Aug 22, 2024 - Abstract #Neuroscience2024Neuroscience_2579; These interventions significantly improved AD pathology and memory function in 5XFAD mice. Currently, we are testing additional drugs to target the synergy of ceramide and S1P, aiming to develop new approaches for AD therapy.
- |||||||||| fingolimod / Generic mfg.
Novel Therapeutic Approach for Comorbid Psychosis in Alzheimer (MCP Hall A) - Aug 22, 2024 - Abstract #Neuroscience2024Neuroscience_1358; Fingolimod is an FDA approved non-specific agonist of S1P receptors...Furthermore, chronic systemic administration was also able to reverse aberrant dopamine system function in the TgWKY-AD model. Taken together, targeting S1P receptors may be a promising novel target for the treatment of comorbid psychosis in Alzheimer
- |||||||||| fingolimod / Generic mfg.
EAE model of multiple sclerosis: prophylactic versus treatment fingolimod (MCP Hall A) - Aug 22, 2024 - Abstract #Neuroscience2024Neuroscience_368; This study reports that the EAE mouse model can effectively mimic MS symptoms and the temporally-dependent start of a daily dose of Fin can prevent disease onset, development of axonal damage, neuroinflammation and inflammatory cell infiltration in the spinal cord. Therefore, it could be a useful approach to studying treatments that may modify these processes and compare their efficacy with Fin
- |||||||||| Zeposia (ozanimod) / BMS
Cytomegalovirus Isolated to a Colon Polyp in a Patient With Ulcerative Colitis on Ozanimod (Exhibit Hall E) - Aug 20, 2024 - Abstract #ACG2024ACG_4916; The natural history and optimal management of isolated CMV remains unclear. Figure: Figure 1A: Sigmoid colon inflammatory polyp 1B: Sigmoid colon polyp pathology revealing CMV inclusion bodies using immunohistochemical staining (original magnification x400) 1C: Sigmoid colon polyp with no evidence of CMV after valganciclovir treatment (original magnification x400)
- |||||||||| Velsipity (etrasimod) / Pfizer
Pregnancy Outcomes in the Etrasimod Clinical Program (Exhibit Hall E) - Aug 20, 2024 - Abstract #ACG2024ACG_4841; Pt characteristics were generally similar between groups, but more pts with SEV vs MOD endoscopic activity had prior immunomodulator (52.8% vs 34.3%), anti 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).
- |||||||||| Zeposia (ozanimod) / BMS, Emgality (galcanezumab-gnlm) / Eli Lilly, Daiichi Sankyo, Organon
Venturing Into the Varied Realm of Varioliform Gastritis: Unveiling an Unconventional Culprit Behind Rare Gastric Lesions (Exhibit Hall E) - Aug 20, 2024 - Abstract #ACG2024ACG_3914; Figure: Figure: A) Esophagogastroduodenoscopy demonstrating numerous subcentimeter annular mucosal lesions with raised edges and central depressions without exudate or significant bleeding in the distal gastric body consistent with varioliform gastritis. B) Repeat esophagogastroduodenoscopy after 6 months of NSAID cessation showing complete resolution of previous annular lesions with normal appearing gastric mucosa in the distal gastric body.
- |||||||||| Zeposia (ozanimod) / BMS
Impact of Baseline Disease Duration on Ozanimod Efficacy in Patients With Moderately to Severely Active Ulcerative Colitis: A Post Hoc Analysis of the Phase 3 True North Study (Exhibit Hall E) - Aug 20, 2024 - Abstract #ACG2024ACG_3182; At TN BL, 158 pts had a disease duration of < 2 y (PBO, n=55; OZA, n=103), 178 had 2 to < 5 y (PBO, n=64; OZA, n=114), 163 had 5 to < 10 y (PBO, n=52; OZA, n=111), and 146 had ?10 y (PBO, n=45; OZA, n=101). BL pt characteristics were generally similar in all subgroups of the OZA and PBO treatment arms.
- |||||||||| Remicade (infliximab) / J&J, Zeposia (ozanimod) / BMS, Rinvoq (upadacitinib) / AbbVie
Evaluating the Time Needed to Access Advanced Therapies for Crohn's Disease and Ulcerative Colitis (Exhibit Hall E) - Aug 20, 2024 - Abstract #ACG2024ACG_3124; The average time to access self-administered therapies ranged from 27.3d to 34.9d, with upadacitinib (UPA) having significantly shorter times relative to other therapies. Subgroup analyses by prior use of advanced therapy revealed a similar pattern with the base case.
- |||||||||| Efficacy of Dual Targeted Therapy for Inflammatory Bowel Disease (Exhibit Hall E) - Aug 20, 2024 - Abstract #ACG2024ACG_3057;
The median disease duration was 8.3 years and median combination therapy duration of 7.2 months. Among 19 UC patients, 17 had extensive colitis while the other 2 had left sided colitis.
- |||||||||| Zeposia (ozanimod) / BMS
Impact of Baseline Albumin Levels on Ozanimod Efficacy: A Post Hoc Analysis of the Phase 3 True North Study (Exhibit Hall E) - Aug 20, 2024 - Abstract #ACG2024ACG_1470; P3 Mean baseline albumin levels were similar in W10 clinical responders vs nonresponders (4.21 vs 4.17 g/dL in OZA Cohort 1; 4.33 vs 4.23 g/dL in OZA Cohort 2). In a quartile analysis of baseline albumin levels, the percentages of W10 clinical responders among OZA-treated pts (Cohorts 1 and 2 combined) slightly increased from 42.2% in Quartile 1 (1.7
- |||||||||| 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.
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