bioSeedin’s Post

The FDA has granted Boehringer Ingelheim Breakthrough Therapy designation to #survodutide for non-cirrhotic metabolic dysfunction-associated steatohepatitis (MASH) with fibrosis, and the company has launched two Phase 3 trials (LIVERAGE & LIVERAGE-Cirrhosis) to evaluate this promising therapy. The Breakthrough Therapy designation expedites the development and review of medicines for serious or life-threatening diseases that have shown preliminary clinical evidence indicating substantial improvement over available treatments. In March, the FDA approved the first-ever MASH therapy, Madrigal Pharmaceuticals’ #Rezdiffra (resmetirom). https://lnkd.in/gNAxr94k With increased focus on MASH therapies, this could be a game-changer in liver disease treatment. Read more here: https://lnkd.in/g3rXJUvQ #MASH #LiverHealth #LiverDisease #Cirrhosis #BreakthroughTherapy

PolTREG will get access to new groups of type-1 diabetes patients with its Treg cellular therapies after signing a cooperation deal with the University Clinical Center (Uniwersyteckie Centrum Kliniczne w Gdansku), in Gdansk, Poland. PolTREG will produce its PTG-007 therapy with blood received from patients selected by the UCC, and deliver the finished product to UCC for a payment. Patients will then be injected with the preparation - derived from their own blood – at UCC. While PTG-007 is not yet on the market, it is available in Poland under a hospital exemption. It has shown a strong safety and efficacy profile in an earlier Phase 1/2 clinical study. PolTREG has the most advanced pipeline of Treg candidate therapies, which it produces in its own state-of-the-art manufacturing facility. It is the only company developing all available modalities of Treg therapies for a wide range of auto-immune diseases, including naturally occurring polyclonal T-cells and several types of next-generation engineered T-cells. PolTREG has 17 years of experience in treating patients with type-1 diabetes as well as multiple sclerosis, a period in which it has treated 100 patients. #biotech #biotechnology #celltherapy #cellandgenetherapy #autoimmunedisease #diabetes #type1diabetes

Join this webinar to hear more around the development of GLP-1s and other incretin based therapies!

We are pleased to announce that we have activated clinical sites and are initiating enrollment for the Phase 1 trial of ADI-001 in autoimmune diseases!   This follows the U.S. Food and Drug Administration’s (FDA) decision to grant Fast Track Designation to ADI-001 for the treatment of relapsed/refractory class III or class IV #lupus nephritis (LN) and clearance from FDA to develop ADI-001 in four #autoimmune indications including LN, systemic lupus erythematosus (#SLE), systemic #sclerosis (SSc) and anti-neutrophil cytoplasmic autoantibody (ANCA)-associated #vasculitis (AAV).   With its safety profile, robust tissue trafficking and complete B cell depletion in peripheral blood and secondary lymphoid tissue (characteristics important in autoimmune treatment), ADI-001 is uniquely differentiated with the goal to bring durable remissions and provide an immune reset for various autoimmune conditions. We are inspired by the idea of bringing to #patients a potential paradigm shift in the treatment of autoimmune diseases. To learn more about participating in this #clinicaltrial, visit https://lnkd.in/esC4winc or email clinicaltrials@adicetbio.com. #CART #celltherapy #gammadelta #clinicaltrials #autoimmune #autoimmuneclinicaltrials #biotech #biotechinvesting #biotechresearch #allogeneic #offtheshelf

https://lnkd.in/gdzB39HE There is a remarkably high level of activity in liver disease diagnostics and drug development. Great insights shared by Tim Jobson in this article about the growing challenge of conducting clinical trials in metabolic associated steatohepatitis (#MASH). “Currently, there are 417 MASH-related clinical trials that are either active or in the recruitment stage”. At Livivos, Inc, we emphasize the urgent need for accurate non-invasive testing (#NIT) in point-of-care settings to support liver disease clinical trials and treatment monitoring. To address this need, we have developed the #LiverScope, which aims to deliver MRI-level accuracy in point-of-care environments. www.livivos.com #clinicaltrials #liverdisease #NASH #PDFF #pointofcare #medicaldevice #steatosis #fattyliver

Inotrem successfully reaches agreement with the #FDA for a Phase 3 registration trial for Nangibotide in septic shock. - Novel biomarker-guided Phase 3 registration trial in septic shock with an enrichment strategy-based patient selection. - Historic paradigm shift in Primary endpoint: from all causes of mortality at Day 29 to proportion of patients alive and free of organ support at Day 29. https://lnkd.in/ep_5NYqM

🔍 Exciting New Research in Diabetes Management! 🔬🩺 I'm thrilled to share insights from a recent article in Diabetes & Metabolic Syndrome: Clinical Research & Reviews (Volume 18, Issue 1, January 2024, DOI: 10.1016/j.dsx.2023.102935). 👩⚕️ Authors: Konstantinos Arvanitakis, Theocharis Koufakis MD, PhD, Georgios Kalopitas, Stavros Papadakos, Kalliopi Kotsa, GEORGIOS GERMANIDIS. Title: Management of type 2 diabetes in patients with compensated liver cirrhosis: Short of evidence, plenty of potential. The interplay between liver diseases and glucose metabolism is crucial, with liver cirrhosis being a significant health burden. T2D and cirrhosis, both associated with high mortality, necessitate a comprehensive therapeutic strategy. The article explores the intricate relationship, shedding light on the increased risk of complications, hepatocellular carcinoma, and all-cause mortality. 🔄 Call to Action: As we delve into the challenges of managing T2D in compensated cirrhosis, the article underlines the importance of ongoing research and future trials. Newer drugs like tirzepatide, SGLT2 inhibitors, and GLP-1 receptor agonists open avenues for further investigation, paving the way for an optimal therapeutic regimen.

Best wishes to all my connections and followers for a happy and healthy #newyear2024! 2024 will be an exciting year for global #pharma and #healthcare. In this first of my Nine for 2024 articles, below, I explore how healthcare systems are moving from fragility to resilience even as serious systemic challenges remain. Watch out for the next article in #PharmaPhorum where I will discuss the implications of one of the biggest changes in the pharmaceutical market for decades- the resurgence of innovation in the mass, chronic diseases of aging, in CV-Met, CNS and beyond. https://lnkd.in/eR386N3G.

ALS, or Lou Gehrig’s Disease, is a disease that causes progressive degeneration of nerve cells in the spinal cord and brain. It affects 30,000 people in the US every year and treatment for it focuses primarily on reducing discomfort and slowing disease progression. US-based company Spinogenix, Inc. is developing a novel drug therapy for ALS that focuses on restoring synapses for patients affected with this disease. The treatment developed is a once-a-day pill that targets synapse loss, which is central to ALS. The company has just received FDA clearance for Investigational New Drug Application for its clinical trials in Australia. Studies so far in healthy volunteers have shown excellent tolerability and plasma levels aligned with efficacy in animal models. Read more about this drug here: https://lnkd.in/g3XiHc6d . . . #research #SimplerScience #als #healthcare #treatment #futureofhealthcare

Published in The New England Journal of Medicine, this study highlights the effectiveness of targeting TL1A, a key protein involved in Inflammatory Bowel Disease (IBD). As a precision medicine approach, this treatment has the potential to revolutionize disease management by balancing pro-inflammatory and anti-inflammatory responses. Our teams at Cedars-Sinai led by Dr. Stephan Targan and Dr. Dermot McGovern, among others, have truly pushed the boundaries of IBD treatment. As this drug progresses, I remain optimistic about the future of precision medicine in helping more people achieve clinical remission and lead healthier lives. #UlcerativeColitis #IBD #PrecisionMedicine #Research #MonoclonalAntibodies #CedarsSinai #PhaseII #ClinicalResearch