Kyverna Therapeutics’ Post

The exciting news about Kyverna Therapeutics and its treatment for Stiff Person Syndrome continues. The FDA giving KYV-101 RMAT designation, which is a major step forward. Check out this latest article by Melissa Rudy on Fox News Media

The first patient with #type2diabetes and diabetes-related complications has been enrolled in a #Phase2 randomized #clinicaltrial of approximately 300 patients with elevated blood glucose, #systemicinflammation and at risk for complications of #diabetes, called DAPAN-DIA, with Olatec’s #NLRP3inhibitor, #dapansutrile. DAPAN-DIA represents the first T2D clinical trial of any selective NLRP3 inhibitor in the emerging class that will also assess cardiometabolic and other risk factors beyond anti-hyperglycemic effects including weight lowering efficacy in combination with GLP-1 therapy The study is being conducted as an investigator-sponsored study under Principal Investigator @Marc Donath MD at the University Hospital of Basel in Switzerland, a long-time Olatec collaborator and advisor as well as a leading researcher-clinician in immuno-metabolism. https://lnkd.in/eZ-RuyNr

Tofacitinib or ustekinumab in patients with ulcerative colitis failing two therapeutic lines? Here are the interesting results from a multicentre international case-control real-world study. Thanks to all friends and colleague who joined this project. https://lnkd.in/dudXaRvs

Data on LEVEL UP, a Phase 3b/4 head-to-head study comparing upadacitinib to dupilumab for the treatment of adult and adolescent patients with moderate-to-severe atopic dermatitis, has just been released. Very happy that our clinical trial center CAC - Centro Hospitalar Universitário de Santo António / ICBAS- Instituto de Ciências Biomédicas Abel Salazar contributed to this trial. Upadacitinib demonstrated superiority versus dupilumab in primary endpoint of simultaneous achievement of near complete skin clearance (EASI 90) and no to little itch (WP-NRS 0/1) at Week 16 [(19.9% vs 8.9% for upadacitinib and dupilumab respectively, p<0.0001)], with a safety profile consistent with the profile in previous atopic dermatitis studies with no new safety signals identified. All information: https://lnkd.in/dQ_apGqB #atopicdermatitis #LEVELUP #upadacitinib #clinicaltrials

Acute pancreatitis is a leading cause of emergency department visits and gastrointestinal admissions in the United States. For patients suffering from this condition, it commonly results in hospitalizations, long term complications, and lost time with family and at work. Lamassu’s lead candidate is a novel small molecule therapy for acute pancreatitis. Developed at the Mayo Clinic by leading scientists, Lamassu’s small molecule therapy approach has profound preclinical efficacy to completely mitigate mortality and morbidity associated with severe acute pancreatitis. Learn more at LamassuBioTech.com.

Lowering the production of apoC-III has been found to decrease fasting triglyceride levels in individuals who lack lipoprotein lipase activity. Read the Viewpoint, published in Med by Cell Press, on the recent phase 3 BALANCE clinical trial examining the impact of olezarsen, a novel antisense oligonucleotide that hinders the expression of apoC-III mRNA, on triglyceride levels and the risk of acute pancreatitis. https://lnkd.in/eyCqA9XF #lipidresearch #triglycerides #pancreatitisprevention #clinicaltrial #BALANCE

The Muscular Dystrophy Association (MDA) has played a crucial role in funding foundational research that has led to the approval of a new drug called Duvyzat (givinostat) by the US Food and Drug Administration (FDA) for the treatment of Duchenne muscular dystrophy (DMD). Duvyzat, a histone deacetylase (HDAC) inhibitor, has shown promising results in slowing the progression of DMD. The approval of Duvyzat provides an additional treatment option for children and adolescents living with DMD. The MDA's funding has supported the development of new treatments like Duvyzat and has expanded the options available for patients with DMD. The approval of Duvyzat is significant as it works differently from other treatments, opening up the possibility of combining it with other therapies to further improve the lives of patients. The MDA's commitment to empowering people with neuromuscular diseases, including muscular dystrophy, has positively impacted patients and their families through resources and advocacy efforts. Overall, the MDA's support and funding have made a significant impact in the field of muscular dystrophy. #MDA #DMD #MuscularDystrophy #Duvyzat #Givinostat #NewTreatment #ResearchFunding #HopeForPatients #EmpoweringPatients #MDAimpact #MuscularDystrophyAwareness

A new #bloodtest for the early detection of #AlzheimersDisease — potentially even before symptoms are present — show that the #diagnostic exhibited high performance metrics, with sensitivity ranging from 99 to 100% and specificity from 95 to 100% across 265 samples. The test from AltPep is called the Soluble Oligomer Binding Assay (SOBA‑AD) and builds on earlier successful results with the assay when it was granted FDA breakthrough device designation two years ago. #AltPep is aiming to test more samples, particularly those with greater racial and ethnic #diversity in the patients. In addition, AltPep is developing a treatment for #Alzheimers and #parkinsonsdisease. #biomarker

ALS patients faced a major setback this quarter... Relyvrio, which had a major impact on the market in 2022, did not meet statistical significance within its pivotal phase 3 trail, PHOENIX. The primary endpoint, change from baseline in the Revised Amyotrophic Lateral Sclerosis Functional Rating Scale (ALSFRS-R) total score, resulted in a p-value of 0.667. Relyvrio is a fixed-dose combination of sodium phenylbutyrate and taurursodiol. PB works to upregulate heat shock proteins and reduce toxicity from endoplasmic reticulum stress. Taurursodiol preserves mitochondria, partially through reducing the permeability of their organelle membranes and preventing apoptosis. ALS differs from MS in that MS is a disease concerning the myelin sheaths of motor neurons, whereas ALS concerns the neurons themselves; however, both conditions result in gradual paralysis and are fatal. Relyvrio was approved based on a single phase 2 trail of 137 patients. https://lnkd.in/gUSUrX3z

🎉 Exciting News in Psoriasis Treatment! 🎉 Boehringer Ingelheim's SPEVIGO injection has received FDA approval for the treatment of generalised pustular psoriasis (GPP), offering new hope for patients battling this challenging condition. The FDA's decision, based on the positive outcomes of the EFFISAYIL 2 clinical trial, marks a significant milestone in psoriasis management. SPEVIGO, a humanised selective IgG1 antibody, targets the interleukin-36 receptor, a key player in the immune system's signalling pathway implicated in the pathogenesis of GPP. Notably, the 48-week EFFISAYIL 2 study demonstrated SPEVIGO's efficacy, with a remarkable 84% reduction in GPP flare risk compared to placebo. Moreover, the high-dose SPEVIGO group showed no flares after week four, highlighting the treatment's potential to provide long-term relief. While SPEVIGO offers promising benefits, it's essential to note the reported adverse events associated with treatment, including reactions at the injection site, urinary tract infections, arthralgia, and pruritus. #PsoriasisTreatment #FDAApproval #HealthcareInnovation #MedicalAdvancements #BoehringerIngelheim #SPEVIGO #GPP #PsoriasisAwareness #PatientCare #psoriasis https://lnkd.in/dMDQ5j9B