NET CONNECT’s Post

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

"STOP-MSU Trial: Tranexamic Acid Ineffective for Intracerebral Haemorrhage" #EliteLegalExperts Dougall McCorry "STOP-MSU Trial" Background: This study evaluated whether intravenous tranexamic acid could reduce haematoma growth in intracerebral haemorrhage patients if administered within 2 hours of symptom onset. Methods: The double-blind, randomized, phase 2 trial included 201 participants from multiple countries, who received either tranexamic acid or a placebo. The primary outcome measured was haematoma growth on CT scans. Findings: There was no significant difference in haematoma growth between the tranexamic acid group and the placebo group. Mortality and safety outcomes were also similar. Interpretation: Tranexamic acid did not show a benefit in reducing haematoma growth and should not be routinely used for primary intracerebral haemorrhage. Further phase 3 trials are ongoing. Read Entire article: https://lnkd.in/d2Kh-AFD

In the BE HEARD I and II phase 3 randomized controlled trials, #bimekizumab yielded quick and sustained clinically meaningful response in patients with moderate to severe #hidradenitissuppurativa. ➡️ https://brnw.ch/21wLce0

BPM's DNlite-IVD103 Receives EU IVDR Certification! On September 30th, 2024 -- BPM announced that its main product, DNlite-IVD103, has received EU IVDR certification. This marks the first EU-IVDR certification issued by BSI in Taiwan. DNlite-IVD103 is also the first innovative diagnostic product globally to receive IVDR certification in the precision management of kidney health. The indication of DNlite-IVD103 has been expanded from type 2 diabetes (DKD) patients to include kidney transplant patients for kidney function prognosis. DNlite-IVD103 is an innovative kidney disease biomarker IVD product for prognosis of kidney function in DKD and kidney transplant patients. In both indications, DNlite-IVD103 can effectively enhance the precision management of kidney health. For more information, please see: https://lnkd.in/eRbBX5a7 #CE #IVDR #DNlite_IVD103 #DKD #KidneyTransplant

https://lnkd.in/gRvgShRS Genentech presents the optimization of TRPA1 antagonists with robust in vivo engagement, offering the potential for neuropathic pain and respiratory disease treatment. Initial lead molecules displayed coagulation parameter prolongation, attributed to an AO-generated metabolite akin to known anticoagulants. Further compound refinement mitigated coagulation effects, leading to clinical candidate GDC-6599, currently in Phase II trials for respiratory indications.

VISION Trial Tepotinib was previously granted accelerated approval for this indication on February 3, 2021, based on initial overall response rate and duration of response in the VISION trial (ClinicalTrials.gov identifier NCT02864992), a multicenter, open-label, multicohort study. The conversion to traditional approval was based on an additional 161 patients and an added 28 months of follow-up time to assess duration of response. Efficacy was demonstrated in a total of 313 patients with metastatic NSCLC harboring MET exon skipping alterations. Patients received tepotinib at 450 mg once daily until disease progression or unacceptable toxicity. Approved this month #Metmutation #fdaapproval #visiontrial #clinicaltrials

How can patients with rare disorders access cutting edge therapeutic discovery programs? Unravel Biosciences is using nasal swab kits to pioneer drug development for rare #CNS diseases. This innovative approach not only simplifies the sample collection process but also ensures a hassle-free, minimally invasive, and physically accessible experience for all #patients. By utilizing swab kits, patients around the world can access BioNAV™, our powerful drug discovery platform to facilitate rapid drug prototyping and accelerate the pace of urgent rare disease treatments. This means we’re bringing #personalized therapies more effectively to patients globally than ever before! #drugdiscovery #rarediseases #rarediseaseday2024

Ophthopedia Update:Glycemic Trends in Thyroid Eye Disease (TED) Patients Treated with Teprotumumab in 3 Clinical Trials: Assess incidence, severity, and outcomes of serum glucose excursions in patients with thyroid eye disease who received the insulin-like growth factor-1 receptor inhibitor, teprotumumab, during pivotal clinical trials. #Ophthalmology #ophthotwitter #eyecare

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

❗A 2023 paper by Y. S. Song et al. investigated the significance of thyroid dysfunction after treatment with atezolizumab and bevacizumab (Ate/Bev) for unresectable HCC. ✅ The study found that under 20% of patients experienced either hypothyroidism and thyrotoxicosis. ✅ These patients demonstrated significantly better progression-free survival, overall survival and objective response rate than those without thyroid adverse effects. Access the complete paper👇 https://ow.ly/NoFW50QBFhm #MedEd #HCC #LiverTwitter