Treg cells are a candidate therapy for type-1 diabetes (T1D) that has proven its efficacy in clinical trials, and is safe. That is the gist of a letter PolTREG published in Science Translational Medicine (STM) in May. It was a reaction to an article that described the lack of efficacy in a Phase 2 clinical trial by Caladrius, also in Treg cells in T1D. When diabetes is diagnosed, the body’s immune system has destroyed almost all the cells producing insulin. That means there is simply nothing left for the Treg cells to protect. But when PolTREG allowed earlier-stage patients into the trial, we saw that patients treated with Tregs were able to still secrete insulin 2, 5 and in some cases, up to 8 years later. A second study showed improved insulin secretion in patients treated with both Tregs and Rituximab. In both studies, patients who did not receive Tregs completely lost the ability to secrete insulin. In our letter, we argue that this change in protocol might have fixed the poor efficacy of the Caladrius trial. And that is good news: it means that there is no reason to doubt the potential that Treg cells to become the first therapy to prevent T1D. PolTREG will be formally presenting long-term safety and efficacy data of its drug candidate PTG-007 in early-onset T1D at a conference in Europe in September. The data are a crucial step in bringing PTG-007 to market, and open up the way for a pivotal Phase 2/3 study. Later this year, PolTREG will launch a study in presymptomatic patients, hoping to prevent T1D before it starts showing any symptoms. This would free patients of the burden of having to take frequent insulin shots, and the serious long-term complications of the disease. To read our letter in STM, click here: https://lnkd.in/dw_fqQhR #biotech #biotechnology #celltherapy #cellandgenetherapy #autoimmunedisease #diabetes #type1diabetes
PolTREG S.A.’s Post
More Relevant Posts
-
PolTREG S.A. Treg cells are a candidate therapy for type-1 diabetes (T1D) that has proven its efficacy in clinical trials, and is safe See more below
Treg cells are a candidate therapy for type-1 diabetes (T1D) that has proven its efficacy in clinical trials, and is safe. That is the gist of a letter PolTREG published in Science Translational Medicine (STM) in May. It was a reaction to an article that described the lack of efficacy in a Phase 2 clinical trial by Caladrius, also in Treg cells in T1D. When diabetes is diagnosed, the body’s immune system has destroyed almost all the cells producing insulin. That means there is simply nothing left for the Treg cells to protect. But when PolTREG allowed earlier-stage patients into the trial, we saw that patients treated with Tregs were able to still secrete insulin 2, 5 and in some cases, up to 8 years later. A second study showed improved insulin secretion in patients treated with both Tregs and Rituximab. In both studies, patients who did not receive Tregs completely lost the ability to secrete insulin. In our letter, we argue that this change in protocol might have fixed the poor efficacy of the Caladrius trial. And that is good news: it means that there is no reason to doubt the potential that Treg cells to become the first therapy to prevent T1D. PolTREG will be formally presenting long-term safety and efficacy data of its drug candidate PTG-007 in early-onset T1D at a conference in Europe in September. The data are a crucial step in bringing PTG-007 to market, and open up the way for a pivotal Phase 2/3 study. Later this year, PolTREG will launch a study in presymptomatic patients, hoping to prevent T1D before it starts showing any symptoms. This would free patients of the burden of having to take frequent insulin shots, and the serious long-term complications of the disease. To read our letter in STM, click here: https://lnkd.in/dw_fqQhR #biotech #biotechnology #celltherapy #cellandgenetherapy #autoimmunedisease #diabetes #type1diabetes
-
-
A phase 1, a multicenter, open-label, intrasubject, dose-escalation study set to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and therapeutic potential of BCX10013 in patients with paroxysmal nocturnal hemoglobinuria (PNH) is currently recruiting. The researchers are looking to enroll approximately 15 adult patients with a documented diagnosis of PNH confirmed by flow cytometry. Patients must be naive to complement inhibitor treatment or have not received ravulizumab within 12 months before the screening and not received eculizumab or pegcetacoplan within 6 months before the screening. Read more: https://brnw.ch/21wDZLM #RareDisease #ClinicalTrial
-
aTyr Pharma, working to develop a new class of drugs based on the extracellular biology of tRNA synthetase, Efzofitimod, presented a post-hoc analysis of the Phase Ib/IIa study in Pulmonary Sarcoidosis at the European Respiratory Society (ERS) at International conference in Milan, Italy. Efzofitimod is being tested in clinical settings to treat interstitial lung disease (ILD). It is a tRNA synthetase-derived treatment that targets inflammation without immunosuppression and selectively regulates activated myeloid cells through Neuropilin-2 to stop fibrosis progression. In September 2021, aTyr Pharma announced positive results from a Phase Ib/IIa clinical trial of ATYR1923 in patients with pulmonary sarcoidosis. Explore More: https://lnkd.in/diGcAW5k #conference #healthcare #biotechnology #lifesciences #consulting #marketresearch #marketforecast #marketanalysis #ers2023 #ERSCongress #conference #healthcareevents
ERS 2023 Updates | aTyr Presented a post-hoc Analysis of its Biologic Immunomodulator, Efzofitimod
delveinsight.com
-
Ahead of print Lecanemab (Leqembi) is not the right drug for patients with Alzheimer’s disease On July 6, 2023, the U.S. Food and Drug Administration (FDA) approved lecanemab (Leqembi) for the treatment of Alzheimer’s dementia (AD) patients. In 2 clinical trials, lecanemab reduced amyloid in the brain and slowed cognitive decline. Here, I review in detail the clinical trial by van Dyck et al. (2023) entitled “Lecanemab in early Alzheimer’s disease”, published in The New England Journal of Medicine on January 5, 2023. In this 18-month trial, lecanemab did not slow cognitive decline in women. This is especially significant because women have a twofold increased risk of AD compared to men, that is, there are 2 times more women than men living with AD. Lecanemab did not slow cognitive decline in APOE4 carriers; rather, it enhanced the decline in study participants with 2 APOE4 genes. This is bad news for AD patients, 60–75% of whom carry at least 1 APOE4 gene. These negative results regarding lecanemab’s therapeutic value make me wonder if the approval of lecanemab was the worst decision of the FDA up till now, after the approval of aducanumab on June 7, 2021. https://lnkd.in/dK6d-SHk
-
-
At the European Respiratory Society (ERS) International Congress 2023, Arrowhead Pharmaceuticals presented crucial findings from their Phase I/II ARORAGE-1001 study, which focuses on addressing inflammatory lung diseases like asthma. This was presented under a Late Breaking Abstract – “A first-in-human study of ARO-RAGE, an RNAi therapy designed to silence pulmonary RAGE expression." The clinical study is a Phase I/IIa, randomized, double-blinded, placebo-controlled trial and consists of two parts: Part 1 focuses on normal healthy volunteers (NHV), and Part 2 shifts the spotlight to patients with inflammatory lung disease. Get a more detailed analysis, at: https://lnkd.in/eRBH8Jiw #conference #healthcare #biotechnology #lifesciences #consulting #marketresearch #marketforecast #marketanalysis #ers2023 #ERSCongress #conference #healthcareevents
ERS 2023 Updates | Arrowhead's RNAi Therapy Prospects for Asthma Treatment
delveinsight.com
-
BioCity Biopharma's SC0062 has achieved a significant milestone by successfully meeting the primary endpoint of proteinuria reduction in the 2-SUCCEED trial. This randomized, double-blind, placebo-controlled, phase 2 clinical trial underscores the efficacy and safety of SC0062 in chronic kidney disease (CKD) patients, particularly those with IgA nephropathy. By selectively targeting the endothelin receptor type A, SC0062 demonstrates promise in mitigating proteinuria, a critical marker of kidney damage and CKD progression. BioCity Biopharma is steadfast in advancing SC0062 development and aims to present detailed findings at upcoming medical conferences and publish the results in a peer-reviewed journal. Read the full article at https://lnkd.in/eu46yETR
BioCity's SC0062 Meets Primary Endpoint in Phase 2 IgA Nephropathy Trial
medicinetomarket.com
-
Another major milestone for #BioAegis in bringing plasma gelsolin therapy to Acute Respiratory Distress Syndrome (#ARDS) patients. Our second partnership with Biomedical Advanced Research and Development Authority (BARDA) Division of Research, Innovation, and Ventures (DRIVe) supports the execution of a large phase 2b global study of recombinant human plasma gelsolin (rhu-pGSN) for moderate-to-severe ARDS. ARDS affects over 700,000 patients in the US per year or roughly 10% of all ICU admissions. The mortality rate for ARDS is approximately 40%. The lack of effective therapies to treat ARDS and its associated high mortality driven by excess #inflammation underscores the urgent need for an innovative therapy in this field. #Gelsolin, a naturally occurring #immunesystem protein, is a master regulator inflammation. It is depleted by counteracting the inflammatory process. Supplementation with the recombinant gelsolin protein (rhu-pGSN) holds promise to address the inflammatory response associated with ARDS. #clinicaltrials #savinglives #pneumonia #sepsis #solvingsepsis #immunotherapy #biotechinvesting #NLR3Pinflammasome #lungdamage
BioAegis Therapeutics Awarded $20 Million BARDA DRIVe Contract to Advance Gelsolin, an Immune Regulator, as a Treatment for Patients with Acute Respiratory Distress Syndrome (ARDS)
globenewswire.com
-
Announcing site recruitment for our global Phase 2 study of #gelsolin for the treatment of #ARDS. Approximately 80 sites in the US, Canada, UK and the EU, including Belgium, France, Italy, Germany, Netherlands, Spain and others will conduct the study. Enrollment is targeted for 600 subjects. This is study is being conducted undercontract with Biomedical Advanced Research and Development Authority (BARDA)’s Division of Research, Innovation, and Ventures (DRIVe), part of the Administration for Strategic Preparedness and Response within the U.S. Department of Health and Human Services. #Gelsolin, a naturally occurring #immunesystem protein, is a master regulator #inflammation. It is depleted by counteracting the inflammatory process. Supplementation with the recombinant gelsolin protein (rhu-pGSN) holds promise to address the overzealous inflammatory response associated with ARDS. "ARDS is significant source of mortality as well as a drain on healthcare resources across the globe. We are committed to reaching our goal of saving lives by addressing the challenges of this complex disease," stated Susan Levinson, Ph.D., Chief Executive Officer of BioAegis. #clinicaltrials #savinglives #pneumonia #sepsis #solvingsepsis #immunotherapy #biotechinvesting #NLR3Pinflammasome #lungdamage
BioAegis Therapeutics Unveils Upcoming Clinical Study of Gelsolin, an Immune Regulator, as a Treatment for Patients with Acute Respiratory Distress Syndrome (ARDS)
globenewswire.com
-
We just published the article titled "Combination Therapy of RAS Inhibition and SGLT2 Inhibitors Decreases Levels of Endotrophin in Persons with Type 2 Diabetes" in the MDPI Special Issue Molecular Mechanisms and Novel Therapies for Chronic Kidney Disease: Focus on Diabetic Kidney Disease: https://lnkd.in/eN37EF-U. Circulating #endotrophin (ETP), a pro-fibrotic signaling fragment generated during #collagen type VI formation, was measured using the PRO-C6 ELISA, developed by Nordic Bioscience, in plasma of individuals from the DC-ren project: https://dc-ren.eu/. Participants were selected from the Prospective Cohort Study in Patients with Type 2 Diabetes Mellitus for Validation of Biomarkers (PROVALID). 💬 Among the investigated circulating markers, ETP was the most significant #predictor of future eGFR. 💬 Combination therapy of #RASi and #SGLT2is led to a reduction in ETP levels compared to RASi monotherapy. 💬 Higher levels of baseline ETP were associated with an increased risk of kidney disease #progression. 💡 Circulating ETP identified individuals at higher #risk of kidney disease progression. The observed decreased levels of ETP with combination therapy may reflect a reduced risk of kidney disease progression following treatment with SGLT2is. ❔ Further research is needed to elucidate the mechanisms of action of current glucose-lowering therapies in reducing kidney #fibrosis. Thanks to the authors: Stefanie Thöni, Felix Keller, Samir Sharifli, Daniel G. K. Rasmussen, PhD, Federica Genovese, Morten Asser Karsdal, Gert Mayer
Combination Therapy of RAS Inhibition and SGLT2 Inhibitors Decreases Levels of Endotrophin in Persons with Type 2 Diabetes
mdpi.com
-
Science and Medical Content Writer | Communications Specialist | Bridging Science and Society
The experimental drug muvalaplin, developed by Eli Lilly and Company, showed promising results in its first human trial by significantly reducing sticky cholesterol-carrying molecules known as lipoprotein(a) or Lp(a), which can clog blood vessels and contribute to cardiovascular disease. The study involved 114 participants and found that muvalaplin effectively lowered Lp(a) levels by up to 65% within 24 hours of the first dose, and the reduction lasted up to 50 days after the treatment. The drug was well-tolerated with no serious adverse effects reported. Phase two clinical trials are now underway to further assess its effectiveness and long-term risks. #CardiovascularHealth #CholesterolReduction #ClinicalTrials
Muvalaplin as an Inhibitor of Lipoprotein(a) Formation
jamanetwork.com
