Partners STADA Group and Calliditas Therapeutics announce the European Commission full approval for Kinpeygo® for the treatment of adults with primary immunoglobulin A nephropathy (IgAN), making it the first fully approved disease-modifying treatment for IgAN in the EU. This approval results in a broader label for patients with primary IgAN and is based on data from the Phase 3 NeflgArd clinical trial, where Kinpeygo met its eGFR endpoints with high statistical significance. Additionally, the EC confirmed Kinpeygo’s status as a rare disease orphan drug, which subjects it to 10-year market exclusivity until 2032. Read More: https://lnkd.in/e78V5Hhg #Nephrology #IgAN #Kinpeygo #STADA #Calliditas
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Today is #WorldKidneyDay, a day to raise awareness of the importance of our kidneys and to reduce the impact of chronic kidney disease, which affects more than 850 million people worldwide. At Medpace, we understand the urgent need for new therapies that are universally accessible to all patients, and we remain committed to accelerating the safe and effective development of nephrology therapeutics. Learn more about how Medpace supports reducing the impact of kidney disease through #nephrology drug development: https://lnkd.in/eqZPJG5U
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Scientific American recently published a piece highlighting the potential of next-generation psychedelics as medicines, especially non-hallucinogenic compounds like Delix Therapeutics's #neuroplastogens. The article features our CSO Kurt Rasmussen and our CMO Aaron Koenig MD discussing our groundbreaking work with our lead #neuroplastogen, DLX-001, and how Delix is pioneering innovative new treatments for #neuropsychiatric conditions that deliver therapeutic benefits without causing hallucinogenic or cardiotoxic effects. Check out the full article: https://lnkd.in/eaWzGF7h.
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This editorial just out in The Lancet (April 2024 in print): “New 52-week histological data from the latest phase 3 trial in patients with NASH and F1 to F3 fibrosis, MAESTRO-NASH, suggest that the selective thyroid hormone receptor β agonist resmetirom could be on a different path. Both 80 mg once-daily and 100 mg once-daily doses were superior to placebo for the primary endpoints of NASH resolution without fibrosis worsening and fibrosis improvement by at least one stage with no worsening of NASH.” “The 52-week histological data meet requirements for early approval by both the FDA and EMA, on the basis that these surrogate outcomes are reasonably likely to predict clinical benefit. Full approval requires showing efficacy on a composite endpoint of all-cause mortality, liver transplantation (FDA only), hepatic decompensation events, MELD score, or histological diagnosis of cirrhosis.” https://lnkd.in/gifCCpqq
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This week is exciting! Two companies announced positive interim results from their respective clinical trials in two rare kidney diseases that have an exceptionally high unmet need for new treatment options. 📣 Dimerix Limited annouced positive interim results for DMX-200 based on the proteinuria efficacy endpoint in its Phase 3 ACTION3 trial in #FSGS. 📣 Regulus Therapeutics announced positive topline data for RGLS8429 based on imaging-based biomarkers in its Phase 1b MAD trial in autosomal dominant polycystic kidney disease (#ADPKD). Through Spherix's tracking of these markets over the years, it is evident that nephrologists are frustrated by the challenges they face in managing these diseases and welcome new therapies to help fulfill the unmet medical needs of their patients. #marketdynamics #marketresearch #nephrology
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Pan et al. explored the physiological and immune effects of xenotransplants in recipients to address the shortage of donor kidneys for transplant patients, highlighting the potential of cross-species organ transplantation to meet the increasing demand for organs. Read Viewpoint from Guillaume Onyeaghala, Casey Dorr, PhD, MS, Ajay Israni, as well as full research paper in Med by Cell Press. #Xenotransplantation #PigToHuman #KidneyTransplant https://lnkd.in/eSYfkrM7
Opportunities and challenges for immunosuppression in the context of pig-to-human xenotransplantation
cell.com
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https://lnkd.in/gDAYHEK9 Article title: Influence of Long-Term Use of Proton Pump Inhibitors on Esophageal and Gastrointestinal Precancerous Lesions or Carcinoma Author(s): Baoge QU; Hao QU Journal: Archives of Clinical Gastroenterology Journal ISSN: 2455-2283 Introduction: Previously the substantial data on long-term treatment of humans with proton pump inhibitors (PPI) has not revealed any definite risks [1] and prolonged gastric acid suppression with PPI rarely produced adverse event [2]. Hence, Proton pump inhibitors have an excellent safety profile [3], supporting the short-and long-term safety of PPI [4]. They have been become a commonly prescribed class of drugs worldwide [3,5], long-term use of PPI is becoming more prevalent [6]. However, current evidences have demonstrated that long-term use of PPI might generate certain adverse events [3]. #InflammatoryBowelDisease #FunctionalGIDisorders #GastrointestinalAndLiverDisease #DigestiveOncology #GastrointestinalSurgery #PediatricGastroenterology #ColorectalCancer #PancreaticCancer #HepatocellularCarcinoma #GastrointestinalBleeding #Endoscopy #Peertechz #PeertechzPublications #SurgicalGastroenterology #StomachUlcers #VirtualColonoscopy #GastricUlceration #RouxenYGastricBypass #GastricAcidSecretion #GastricMucosa #GastricUlcerHealing #GastricCardiaCancer #ReproductiveEndocrinology #EndocrineDisorders #Hepatology #AlimentaryCanal #PancreasCancer
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Our Professor Antti Poso was involved in research collaboration which developed a first-in-class small-molecule-based MKK4 inhibitor (HRX215). This inhibitor increased liver regeneration after hepatectomy in murine and porcine models. In addition, the inhibitor(HRX215) was safe, and it had excellent pharmacokinetics in humans in a phase I trials. #Drugdevelopment #liverdisease #kinases https://lnkd.in/dr2VGDd2
First-in-class MKK4 inhibitors enhance liver regeneration and prevent liver failure
cell.com
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Ari Grinspan, MD, discusses his study regarding the use of fecal microbiota transplantation as treatment for patients with inflammatory bowel disease. The future is bright for the use of microbiota therapeutics in patients with IBD." - Dr. Ari Grinspan #IBD #FecalMicrobiotaTransplantation #HealthcareInnovation #MedicalResearch #Gastroenterology #PatientCare #MicrobiotaTherapeutics Mount Sinai Department of Medicine https://lnkd.in/edUwxjrb
Q&A: ‘Future is bright' for use of microbiota therapeutics in patients with IBD
healio.com
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Programmable & Targeted Drug Delivery, iprecio@Primetech.co.jp Worldwide. <Approaches to Achieve Extended PK Profiles in Drug Discovery>
#DrugDelivery #CNS #NoseToBrainDelivery #ProteinTherapeutics This research showcases the pivotal role of olfactory mucosa in nose-to-brain delivery, boasting an efficacy rate of nearly 45% in comparison to intracerebroventricular (ICV) administration. The study suggests the potential of this approach as a less invasive method for treating CNS diseases, offering a safer alternative to conventional clinical routes for CNS drug delivery. Check out the details in the Journal of Controlled Release by Di Francesco, Valentina, and team. Link included in comments. #DrugDelivery #CNS #NoseToBrainDelivery #NeurodegenerativeDiseases #ProteinTherapeutics #MicrofluidicInfusionSystem My original text. Above enhanced by LinkedIn's AI #DrugDelivery #CNS #NoseToBrainDelivery #ProteinTherapeutics "This research highlights the significant role of olfactory mucosa in nose-to-brain delivery, with an efficacy of nearly 45% compared to intracerebroventricular (ICV) administration." "This demonstrates its potential as an alternative procedure for treating CNS diseases, offering a greater safety profile relative to the highly invasive clinical routes traditionally adopted for CNS drug delivery" from Di Francesco, Valentina, et al. "Minimally invasive nasal infusion (MINI) approach for CNS delivery of protein therapeutics: A case study with ovalbumin." Journal of controlled release: official journal of the Controlled Release Society: S0168-3659. [Open Access]
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Oncology patients who suffer from chronic cancer have shown to have oncogenic related anemia. This is generally due to the chronic inflammation that the body is under which impairs oxygen absorption and iron stores. While iron concentration may appear to be in normal range, the TIBC will be decreased with the ferritin levels typically increased. This level of functional anemia has shown prospective clinical indications when it comes it the treatment of these patients. Studies suggest a multimodal approach for this patient population that includes modulators of iron metabolism, nutritional support, and/or anti-inflammatory drugs. ESA has been a very prospective drug that showed a positive hematological response as well as a decrease in blood transfusions. These are several other pharmacological recommendations in this article below. Further research needs to be done regarding drugs that target the Activin II receptor signaling pathway as well as drugs that target the iron metabolism. As always, let me know your thoughts!
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