Sanofi’s Post

It’s great to see these results for the benefit of IBD patients 🙌🏻. This clinical trial demonstrates that treatment with Duvakitug for ulcerative colitis results in clinical remission and endoscopic response in Crohn's disease. Also, this anti-TL1A therapy shows a remarkable efficacy, tolerability and safety profile.

The #Phase2b results demonstrate that #Duvakitug has shown #best-in-class potential #efficacy in achieving #clinicalremission and #endoscopicresponse in #IBDpatients. Duvakitug was generally #welltolerated in both #UC and #CD with no safety signal identified. This development underscores Sanofi commitment to the #Gastroenterology patients and #providers. This #progress is a testament to the importance of continued #research and #collaboration (Sanofi and Teva Pharmaceuticals) in the #pharmaceuticalindustry to address #unmetmedicalneeds. #RELIEVEUCCD

As we build #SanofiImmunology Franchise to be a leader in Immunology, we are thrilled with today's announcement of the Ph 2 data with #Duvakitug, our partnered #TL1A asset with #TEVA. Duvakitug demonstrated Best-in-Class results in both UC and CD; and is the first TL1A to announce placebo controlled data in CD. We are excited to take this asset into Ph 3 after regulatory consultations. #SanofiImmunology #TL1A #duvakitug #TEVA #IBD #UC #CD #miraclesofscience

Promising results in Inflammatory Bowel Diseases (IBD) Treatment with Duvakitug : Targeting TL1A (Tumor Necrosis Factor like Ligand 1A) Cytokines. Research has shown that TL1A cytokines play a crucial role in exacerbating inflammation, fibrosis, and disease severity in Ulcerative Colitis (UC) and Crohn's Disease (CD). Blocking TL1A cytokines with Duvakitug, a novel IgG monoclonal antibody, has shown promising results in improving IBD outcomes. The Phase 2 RELIEVE UCCD trial results are a significant step forward. Read more about this groundbreaking development and its potential to transform IBD treatment.

Calliditas Therapeutics AB’s partner, Viatris Pharmaceutical Japan G.K., has initiated a phase III clinical trial with Nefecon (VR-205) in Japanese patients with IgA nephropathy. This randomized, double-blind, placebo-controlled study will evaluate the efficacy and safety of Nefecon, a potential novel treatment for this autoimmune kidney disease. IgA nephropathy is a leading cause of chronic kidney disease and end-stage renal disease worldwide, with limited available treatments. This trial marks a significant milestone towards potentially commercializing Nefecon in Japan, offering new hope to patients. Read the full article at https://lnkd.in/eNfBdSHk

Explore this interactive pharmaceutical resource to learn about pivotal studies of an investigational drug that targets transient receptor potential melastatin 8 (TRPM8) receptors for the treatment of signs and symptoms of dry eye disease: http://spr.ly/6048qz97A #Alcon #Ophthalmology #DryEye

ORIC-533: A Bioavailable Monophosphonic Acid Inhibitor of CD73 for the Treatment of Multiple Myeloma | https://lnkd.in/gbrkBv8h ORIC Pharmaceuticals Inc.'s recent disclosure of their CD73 inhibitor, ORIC-533, at the ACS Spring 2024 First Time Disclosures session in New Orleans, revealed a potentially best-in-class AMP mimic and the only bioavailable CD73 inhibitor in the clinic. Currently, in a Ph. Ib trial for relapsed/refractory multiple myeloma, ORIC-533’s discovery story illustrates how judicious use of structural information can lead to exquisitely potent compounds and overcome scaffold-based exposure limitations. To read more about this exciting next-generation immunotherapy, check out the story on Drug Hunter | https://lnkd.in/gbrkBv8h

Alport Syndrome Pipeline and Clinical Trials Assessment 2024: FDA Approvals, Therapies and Key Companies involved by DelveInsight | Enyo Pharma, Calliditas Therapeutics, Travere Therapeutics, Inc.: (Las Vegas, Nevada, United States) As per DelveInsight’s assessment, globally, Alport Syndrome pipeline constitutes 8+ key companies continuously working towards developing 10+ Alport Syndrome treatment therapies, analysis of Clinical Trials, Therapies, Mechanism of Action, Route of Administration, and Developments analyzes … Continue reading → #Business #HealthMedicine #MarketingSales #PharmaceuticalsBiotech

📣 NEW! Amylyx Pharmaceuticals announces acquisition of hyperinsulinemic hypoglycemia drug Avexitide with FDA Breakthrough Therapy Designation. Avexitide, a phase-3 ready GLP-1 receptor antagonist, was initially developed by Eiger BioPharmaceuticals. While the drug is currently moving forward for post-bariatric hypoglycemia (PBH), it has also completed Phase 2 studies for congenital hyperinsulinism (HI). 📣 Amylyx reports that they are “actively engaging in discussions with the broader congenital HI community, including experts in the field, to develop a path forward based on promising Phase 2 study results conducted at Children's Hospital of Philadelphia” - you can find more information about this development in Amylyx Pharmaceutical’s recent press release here: https://lnkd.in/eNE9D-Uh 🔗 #hyperinsulinism #raredisease #congenitalhyperinsulinism #hypoglycemia | Hyperinsulinism | Congenital | HI | Hypoglycemia | Rare Disease

Nonclinical Safety Assessment of Oligonucleotide-Based Therapeutics FDA issued draft guidance for comments Not for implementation. Contains non-binding recommendations. This guidance is being distributed for comment purposes only. Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the FDA considers your comment on a draft guidance before it begins work on the final version of the guidance, submit either online or written comments on the draft guidance before the close date. #fda #draft #guidance #comments #oligonucleotides #therapeutics https://lnkd.in/gQSBFfqy