- |||||||||| Zeposia (ozanimod) / BMS, Mayzent (siponimod) / Novartis
Journal: Computational Analysis of S1PR1 SNPs Reveals Drug Binding Modes Relevant to Multiple Sclerosis Treatment. (Pubmed Central) - Nov 27, 2024 The binding free energies varied from the least favorable -8.2 kcal/mol for the wild type with ozanimod to the most favorable -16.7 kcal/mol for the combination of siponimod with the receptor carrying the F2055.42L mutation. We successfully demonstrated the differences in the binding modes, interactions, and affinities of investigated MS drugs in connection with SNPs in the S1PR1 binding site, resulting in several viable options for personalized therapies depending on the present mutations.
- |||||||||| Zeposia (ozanimod) / BMS
Trial completion, Enrollment change, Trial completion date, Trial primary completion date: A Study to Evaluate the Efficacy, Safety, and Drug Levels of Oral Ozanimod in Pediatric Participants With Moderately to Severely Active Crohn's Disease With an Inadequate Response to Conventional Therapy (clinicaltrials.gov) - Nov 26, 2024 P2/3, N=5, Completed, A prolonged washout should be avoided for lymphocyte recovery. Active, not recruiting --> Completed | N=120 --> 5 | Trial completion date: Mar 2032 --> Sep 2024 | Trial primary completion date: Sep 2026 --> Sep 2024
- |||||||||| fingolimod / Generic mfg.
Preclinical, Journal: Behavioral Analyses in Dark Agouti Rats Following Repeated Systemic Treatment With Fingolimod (FTY720). (Pubmed Central) - Nov 18, 2024 The present findings indicate that treatment with FTY720 did not induce typical anxiety-like behavioral patterns in otherwise healthy rats as seen following treatment with other immunosuppressive drugs. Nevertheless, it remains of great importance to evaluate behavioral effects in clinical practice to shed more light onto possible detrimental side effects emerging during treatment with small-molecule immunosuppressive drugs.
- |||||||||| fingolimod / Generic mfg.
Trial completion date, Trial primary completion date: Phase 2 Study of Fingolimod in Lung Cancers (clinicaltrials.gov) - Nov 18, 2024 P2, N=38, Not yet recruiting, Nevertheless, it remains of great importance to evaluate behavioral effects in clinical practice to shed more light onto possible detrimental side effects emerging during treatment with small-molecule immunosuppressive drugs. Trial completion date: May 2027 --> Nov 2027 | Trial primary completion date: May 2026 --> Nov 2026
- |||||||||| Lemtrada (alemtuzumab) / Sanofi
Retrospective data, Journal: Infection Risk Associated with High-Efficacy Disease-Modifying Agents in Multiple Sclerosis: A Retrospective Cohort Study. (Pubmed Central) - Nov 17, 2024 Patients initiating heDMAs (natalizumab, alemtuzumab, and ocrelizumab) or meDMAs (interferon beta-1a, interferon beta-1b, fingolimod, teriflunomide, dimethyl fumarate, and glatiramer acetate) were included...In MS, heDMAs were associated with a greater risk of serious infection and UTI compared with meDMAs. These findings suggest the need to carefully monitor and manage the infection risk to optimize the use of heDMAs in MS.
- |||||||||| Zeposia (ozanimod) / BMS
Review, Journal: The discovery and development of the sphingosine 1-phosphate receptor modulator ozanimod in ulcerative colitis. (Pubmed Central) - Nov 16, 2024 In this review, the discovery and development of the first approved S1P modulator, ozanimod, is described in detail: from design of initial screens to discover unique binding agents, to extensive chemical modifications to improve pharmacokinetic and safety profiles, and through preclinical and clinical studies validating mechanism and establishing safety and efficacy. Ultimately, this review will not only inform the reader of the unique path to development of a clinical S1P modulator for UC, but will also highlight advances made and gaps remaining to individualize therapeutic approaches for inflammatory bowel disease.
- |||||||||| fingolimod / Generic mfg.
Review, Journal: Sphingosine-1-phosphate signalling in the heart: exploring emerging perspectives in cardiopathology. (Pubmed Central) - Nov 13, 2024 The intricate interplays involving S1P and its receptors are analysed concerning different cardiac cell types, shedding light on their respective roles in different heart diseases. We also review the therapeutic applications of targeting S1P/S1PRs in cardiac diseases, considering existing drugs like Fingolimod, as well as the prospects and challenges in developing novel therapies that selectively modulate S1PRs.
- |||||||||| Zeposia (ozanimod) / BMS
Enrollment open, Phase classification, Enrollment change: Prospective Evaluation of Sequencing From antiCD-20 Therapies to Ozanimod (clinicaltrials.gov) - Nov 8, 2024 P4, N=24, Recruiting, We also review the therapeutic applications of targeting S1P/S1PRs in cardiac diseases, considering existing drugs like Fingolimod, as well as the prospects and challenges in developing novel therapies that selectively modulate S1PRs. Not yet recruiting --> Recruiting | Phase classification: P1/2 --> P4 | N=48 --> 24
- |||||||||| fingolimod / Generic mfg.
Journal: Effect of Fingolimod on Lymphocyte Subsets in Patients With Relapsing Multiple Sclerosis. (Pubmed Central) - Nov 4, 2024 Discussion Our findings support that the fingolimod treatment has significant effects on both lymphocyte counts and lymphocyte subgroup ratios. The results show the mechanism of action of fingolimod is unaccountable only through T lymphocytes, and it is effective in both B lymphocyte subgroups and T lymphocytes.
- |||||||||| Zeposia (ozanimod) / BMS
Trial completion date, Trial termination, Trial primary completion date: A Placebo-Controlled Study of Oral Ozanimod as Maintenance Therapy for Moderately to Severely Active Crohn's Disease (clinicaltrials.gov) - Nov 4, 2024 P3, N=551, Terminated, The results show the mechanism of action of fingolimod is unaccountable only through T lymphocytes, and it is effective in both B lymphocyte subgroups and T lymphocytes. Trial completion date: Mar 2026 --> Oct 2024 | Active, not recruiting --> Terminated | Trial primary completion date: Dec 2025 --> Oct 2024; The study has terminated due to non-safety reasons; Business Objectives have changed.
- |||||||||| Mavenclad (cladribine) / EMD Serono, Lemtrada (alemtuzumab) / Sanofi
Clinical, Review, Journal, HEOR, Cost-effectiveness, Cost effectiveness: Cost-effectiveness of oral versus injectable disease modifying therapies in relapsing multiple sclerosis: a systematic review analysis. (Pubmed Central) - Oct 29, 2024 However, despite the difference in the results, Cladribine tablets were cost-effective in all studies compared with injectable drugs. In addition, the present study could be of great importance for policymakers and other beneficiaries regarding the cost-effectiveness of the aforementioned drugs.
- |||||||||| Mavenclad (cladribine) / EMD Serono
Journal: Harmonized Data Quality Indicators Maintain Data Quality in Long-Term Safety Studies Using Multiple Sclerosis Registries/Data Sources: Experience from the CLARION Study. (Pubmed Central) - Oct 22, 2024 CLARION, a non-interventional cohort safety study of cladribine tablets, combines aggregated data from MS registries/data sources, except in Germany (which utilizes primary data collection)...Regarding Completeness DQIs, 191/5069 (3.8%) patients were lost to follow-up. The application of 28 DQIs within the CLARION study has helped with understanding, not only intrinsic and question-specific determinants of data quality, but also tracking the quality of post-authorization safety data obtained from MS registries/data sources, thereby providing a foundation for the regulatory decision-making process.
- |||||||||| fingolimod / Generic mfg.
Preclinical, Journal: The Effect of FTY720 on Sphingolipid Imbalance and Cognitive Decline in Aged EFAD Mice. (Pubmed Central) - Oct 22, 2024 FTY720 did not reverse memory deficits in E4FAD and APOE4 mice but reduced specific ceramide species. This study provides insights into the association between sphingolipids and APOE4 in advanced AD stages, exploring potential therapeutic targeting of sphingolipid metabolism.
- |||||||||| vibozilimod (SCD-044) / Sun Pharma
Enrollment closed, Trial completion date, Trial primary completion date: SOLARES-PsO-1: To Assess the Effect of SCD-044 Treatment on Moderate to Severe Plaque Psoriasis (clinicaltrials.gov) - Oct 21, 2024 P2, N=263, Active, not recruiting, This study provides insights into the association between sphingolipids and APOE4 in advanced AD stages, exploring potential therapeutic targeting of sphingolipid metabolism. Recruiting --> Active, not recruiting | Trial completion date: Nov 2024 --> Apr 2025 | Trial primary completion date: Aug 2024 --> Nov 2024
- |||||||||| Zeposia (ozanimod) / BMS
Review, Journal: Ozanimod: A Review in Relapsing Forms of Multiple Sclerosis. (Pubmed Central) - Oct 17, 2024 Notably, ozanimod does not require first-dose cardiac monitoring in the USA. In conclusion, ozanimod is a valuable once-daily oral disease-modifying therapy that extends the available treatment options for patients with RMS.
- |||||||||| fingolimod / Generic mfg.
Journal: Ophthalmic Nanoemulsion Fingolimod Formulation for Topical Application. (Pubmed Central) - Oct 17, 2024 In vivo studies revealed that effective concentrations of FT were achieved in the vitreous humor and retina following topical application of FT-NE. The results from these studies demonstrate that the FT-NE formulation can serve as a viable platform for the ocular delivery of FT through the topical route.
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