Latest news with #varoglutamstat


Daily Mail
2 days ago
- Health
- Daily Mail
I was diagnosed with Alzheimer's after ‘overused' medical procedure caused my dementia
Sean Fischer's mother had been getting sicker for decades. She would ask the same question multiple times, be bedbound from migraines and unstable on her feet. The mystery behind her decades-long ailments was seemingly solved when she was diagnosed with Alzheimer's disease in June 2022. Sean said: 'We had spent countless hours fretting over what could be wrong, but not once did I think it could be early-onset Alzheimer's. That diagnosis belongs to other families, I thought. Not ours.' The Fischers met with renowned neurologists and prepared the then-61-year-old to participate in an Alzheimer's clinical trial for the drug varoglutamstat. Then came devastating news that meant Mrs Fischer wouldn't be eligible for the trial - she was suffering from a persistent leak of spinal fluid somewhere in her spinal system, but doctors couldn't pinpoint the source - and couldn't fix it. They believed it was likely a result of epidurals she'd received during childbirth - an injection in the back that numbs a person from their belly button to their thighs. It's a common pain relief option during childbirth and an estimated 61 percent of women who give birth receive an epidural. After suffering for more than a decade, doctors said a new procedure would allos them to inject dye into Mrs Fischer's spinal fluid to search for the leak - a small spot in the middle of her back. A few weeks after they sealed it, all of her symptoms went away and doctors said she didn't actually have Alzheimer's - the tiny spot in her back was actually the source of all her symptoms. Mrs Fischer's health battle began long before her Alzheimer's diagnosis. It started in spring 2001, when Sean said he received a call from his dad: Mom had pulled over on the highway, vomiting from a sudden, crushing headache. Her doctor called it a migraine, but months later she lost hearing in one ear and was diagnosed with Ménière's disease. She adjusted — avoiding movements that triggered vertigo, wearing a hearing aid in her forties, and taking daily meds for the headaches. Even as she quietly suffered, Sean wrote for The Free Press, she stayed steady for him and his brothers, never missing a soccer game, school musical, or packed lunch. In 2010, neurologists at Columbia University diagnosed her with a Chiari malformation, a structural defect where the brain is pushed through the opening at the base of the skull. They suspected the malformation was caused by a cerebrospinal fluid leak, sparked by her three epidurals from the births of each of her sons. Epidurals are extremely safe and are administered by inserting a needle in the space of the lower spine just outside the membrane that surrounds the spinal cord. It delivers anesthetic medication, which numbs the lower half of the body and blocks pain while allowing the patient to stay awake and alert. However, it can occasionally result in a leak if the needle punctures the thin, tough membrane surrounding the spinal cord containing the CSF, called the dura mater. When this happens, some of the fluid that cushions and protects the brain and spinal cord can leak out into surrounding tissues. It can only be patched up surgically. The leak had, over the years, led to a loss in cerebrospinal fluid volume, causing her brain to sink. This can lead to severe headaches, nausea and vomiting, hearing changes, memory problems, and double vision. 'I started high school in 2015, and around that time, I began to notice the quiet dislocation of my mom's mind,' Sean wrote for The Free Press. 'When we cooked dinner together, she would have trouble following recipes. She'd stare at her calendar for long stretches of time; making sense of it seemed to require more effort than usual. She started to repeat herself. 'By the time I left for college in Rhode Island, the phrase 'You already asked me that' had become a common refrain in the house I grew up in, but at first, we blamed her, telling her she needed to pay more attention.' She was seeing doctors for headaches, hearing, and anxiety, none of whom believed there could be a common origin. Her memory problems were worsening as well, which led to Mr and Mrs Fischer to to turn to NYU Langone Health's Center for Cognitive Neurology. 'My mom was tested extensively — and two months later came the diagnosis, with the finality of a punctuation mark. Alzheimer's. When it hit her that there was no cure, my mom was bedridden for three days,' Sean said. Hope came with the study. But then doctors called the Fischers and informed them that the CSF leak would not allow her to participate. Despair took over. But a few weeks later, Mrs Fischer's doctor called to tell them about recent medical innovations that would allow surgeons to find and fix the leak, allowing her to participate in the drug trial. Six months later, doctors inserted a probe through the femoral artery in Mrs Fischer's leg, fed it upward toward her spinal system, and sealed the leak. Sean said: 'Two weeks later, I visited home, and found Mom more alert than she had been in years. There was no absent look in her eyes. As the day went on, I waited for her to start fading—but she was still wide awake at 10 p.m. 'After three weeks, her vertigo was gone, and her physical therapist told her she didn't need treatment anymore, because she no longer had any balance problems. After four weeks, she told us she felt 20 years younger.' After six weeks, her problems with memory were gone entirely. 'And eventually, Mom's neurologist confirmed: She did not have Alzheimer's. The surgeons who fixed the leak were shocked. They had never seen a recovery like it,' Sean said. The family later learned that, a year before the procedure, Cedars-Sinai Medical Center had published a newsletter with the subtitle: 'Physicians Treating Dementia Should Look for Cerebrospinal Fluid Leak—A Treatable Cause of an Otherwise Incurable Condition.' The study followed 21 patients with headaches, severe fatigue, and diagnoses of Chiari malformation and dementia; nine were found to have a cerebrospinal fluid leak, and repairing it completely resolved their symptoms. In Sean's mother's case, countless specialists across multiple hospitals treated her symptoms in isolation, overlooking the root cause. But they chose not to place blame on any doctor or institution. It was the system that misdiagnosed her, and ultimately, the system that saved her. 'More than anything, we feel grateful that a scientific breakthrough came at just the right time; that the real cause of her suffering was found,' he said.
Yahoo
06-06-2025
- Health
- Yahoo
Vivoryon Therapeutics N.V. Presents Meta-analysis Data of VIVIAD and VIVA-MIND studies at ERA 2025
Vivoryon Therapeutics N.V. Presents Meta-analysis Data of VIVIAD and VIVA-MIND studies at ERA 2025 Halle (Saale) / Munich, Germany, June 6, 2025 – Vivoryon Therapeutics N.V. (Euronext Amsterdam: VVY; NL00150002Q7) (Vivoryon), a clinical stage company developing small molecule medicines for inflammatory and fibrotic disorders, with a primary focus on kidney diseases, today announced that meta-analysis data for its lead drug in development, varoglutamstat, was presented at the 62nd ERA Congress of the European Renal Association in Vienna, Austria, today, June 6, 2025. 'We are delighted that the results of the Phase 2 program were accepted for presentation at the ERA 2025 congress. This allowed Vivoryon to share the outstanding improvements of varoglutamstat on kidney function (eGFR) with the scientific and medical expert community in the kidney space,' said Frank Weber, MD, CEO of Vivoryon. Presentation HighlightsVaroglutamstat is a first-in-class glutaminyl cyclase (QPCT/L) inhibitor with potent anti-inflammatory and anti-fibrotic effects. VIVIAD and VIVA-MIND, two independent Phase 2 studies in the EU and U.S. showed a statistically significant and clinically meaningful improvement in a prospectively defined kidney function parameter, eGFR, in an elderly patient population. This improvement was consistent in both trials independently, replicated in the meta-analysis and pooled analysis, and provides converging evidence for this finding. Statistically significant differences between varoglutamstat and placebo were first observed at week 24 and were sustained until week 96. The meta-analysis also confirmed a substantially larger effect size in study participants with diabetes compared to those without diabetes. The next step is planned to be a dedicated Phase 2b trial in patients with diabetic kidney disease (patients with diabetes and chronic kidney disease stage 3b/4). The main goal will be to investigate the efficacy on eGFR in this patient population and to obtain additional information on a potential effect on proteinuria and other kidney specific markers. Presentation Details Date: June 6, 2025Presentation time: 8:15 am CEST as part of the focused oral sessionTitle: Varoglutamstat improves eGFR and offers a new approach to treat diabetic kidney disease (DKD): meta-analysis from two independent Phase 2 studiesVenue: Vienna, Austria Presenter: Frank Weber, MD, CEO of Vivoryon Therapeutics ### About Vivoryon Therapeutics is a clinical stage biotechnology company focused on developing innovative small molecule-based medicines for the treatment of inflammatory and fibrotic disorders of the kidney. Driven by its passion for ground-breaking science and innovation, the Company strives to improve patient outcomes by changing the course of severe diseases through modulating the activity and stability of pathologically relevant proteins. Vivoryon's most advanced program, varoglutamstat, a proprietary, first-in-class orally available QPCT/L inhibitor, is being evaluated to treat diabetic kidney disease. press release includes forward-looking statements, including, without limitation, those regarding the business strategy, management plans and objectives for future operations of Vivoryon Therapeutics N.V. (the 'Company'), estimates and projections with respect to the market for the Company's products and forecasts and statements as to when the Company's products may be available. Words such as 'anticipate,' 'believe,' 'estimate,' 'expect,' 'forecast,' 'intend,' 'may,' 'plan,' 'project,' 'predict,' 'should' and 'will' and similar expressions as they relate to the Company are intended to identify such forward-looking statements. These forward-looking statements are not guarantees of future performance; rather they are based on the Management's current expectations and assumptions about future events and trends, the economy and other future conditions. The forward-looking statements involve a number of known and unknown risks and uncertainties. These risks and uncertainties and other factors could materially adversely affect the outcome and financial effects of the plans and events described herein. The Company's results of operations, cash needs, financial condition, liquidity, prospects, future transactions, strategies or events may differ materially from those expressed or implied in such forward-looking statements and from expectations. As a result, no undue reliance should be placed on such forward-looking statements. This press release does not contain risk factors. Certain risk factors that may affect the Company's future financial results are discussed in the published annual financial statements of the Company. This press release, including any forward-looking statements, speaks only as of the date of this press release. The Company does not assume any obligation to update any information or forward-looking statements contained herein, save for any information required to be disclosed by law. For more information, please contact: Investor ContactsVivoryon Therapeutics Manuela Bader, Director IR & CommunicationEmail: IR@ LifeSci AdvisorsSandya von der Weid Tel: +41 78 680 05 38Email: svonderweid@ Media ContactTrophic CommunicationsValeria Fisher or Verena SchossmannTel: +49 175 8041816 / +49 151 219 412 77Email: vivoryon@ Attachment 20250606_ERA_VVYSign in to access your portfolio
Yahoo
27-05-2025
- Business
- Yahoo
Vivoryon Therapeutics N.V. Expands Intellectual Property Portfolio with New U.S. Composition of Matter Patent Granted for Varoglutamstat
Vivoryon Therapeutics N.V. Expands Intellectual Property Portfolio with New U.S. Composition of Matter Patent Granted for Varoglutamstat Newly granted U.S. patent expected to provide exclusivity through 2044 with subsequent opportunity for patent term extension New U.S. patent granted after accelerated examination process covers the active polymorph of varoglutamstat, Vivoryon's lead drug in development Additional patents for medical use and dosing regimens under examination for varoglutamstat and related structures in kidney disease as monotherapy and in combination with SGLT-2 inhibitors Halle (Saale) / Munich, Germany, May 27, 2025 – Vivoryon Therapeutics N.V. (Euronext Amsterdam: VVY; NL00150002Q7) (Vivoryon), a clinical stage company focused on the discovery and development of small molecule medicines to modulate the activity and stability of pathologically altered proteins, today announced that the United States Patent and Trademark Office (USPTO) has granted an additional patent covering the Company's lead drug in development, varoglutamstat. The new patent was granted after an accelerated examination process. 'Vivoryon pursues a diligent and comprehensive strategy to continuously strengthen the intellectual property protecting our key assets on multiple levels. This successful patent application demonstrates our strong commitment to protecting the innovation of our lead asset varoglutamstat and is an important milestone for Vivoryon. The fact that it has been granted several months ahead of the anticipated timing is a testament to the outstanding work of our team,' said Frank Weber, MD, CEO of Vivoryon. 'We expect that this long patent runway will support our efforts to maximize the full therapeutic potential of varoglutamstat, which we plan to develop in kidney disease.' The newly granted composition of matter US patent (US 12,312,335) covers the only polymorph of the salt form used in the drug product of Vivoryon's unique QPCT/L inhibitor varoglutamstat. The patent has a scheduled runtime through 2044, with the subsequent opportunity for a patent term extension of up to five years to 2049 under the Hatch-Waxman Act. In addition, the Company has filed a number of different patents in its focus area of kidney disease over the past months. These relate to varoglutamstat and related structures, covering medical use, and dosing regimens, both as monotherapy and in combination with standard of care, namely SGLT-2 inhibitors. Adding an additional layer of protection, the patent applications cover the free base and all salt forms of varoglutamstat and are currently under examination. Vivoryon has a strong patent portfolio for QPTC/L inhibition and continues to evolve its IP strategy based on scientific evidence, striving to bolster its IP portfolio on multiple levels. Patent applications and granted patents span composition of matter, medical use as well as indications and dosing regimens. Recent additions to the portfolio relate to the Company's primary field of focus, diseases of the kidney and include patents for the combination of QPCT/L inhibitors with standard of care, SGLT-2 inhibitors. These patents were filed based on the outstanding effect observed in preclinical research, where data revealed synergistic effect of the combination treatment with varoglutamstat and an SGLT-2 inhibitor with both once and twice daily treatment. The Company has a strong patent portfolio relating to QPCT/L inhibitors in a broad range of diseases with high medical need, including kidney diseases, inflammatory diseases, oncology, genetic and fibrotic diseases. The portfolio is comprised of over 20 patent families and over 400 patent applications and issued patents covering all major markets, with composition of matter patents on QPCT/L inhibitors representing the clear majority and with recent patent applications reflecting Vivoryon's focus on kidney diseases. ### About Vivoryon Therapeutics is a clinical stage biotechnology company focused on developing innovative small molecule-based medicines. Driven by its passion for ground-breaking science and innovation, the Company strives to change the lives of patients in need suffering from severe diseases. The Company leverages its in-depth expertise in understanding post-translational modifications to develop medicines that modulate the activity and stability of proteins which are altered in disease settings. The Company has established a pipeline of orally available small molecule inhibitors for various indications including Alzheimer's disease, inflammatory and fibrotic disorders, including of the kidney, and cancer. press release includes forward-looking statements, including, without limitation, those regarding the business strategy, management plans and objectives for future operations of Vivoryon Therapeutics N.V. (the 'Company'), estimates and projections with respect to the market for the Company's products and forecasts and statements as to when the Company's products may be available. Words such as 'anticipate,' 'believe,' 'estimate,' 'expect,' 'forecast,' 'intend,' 'may,' 'plan,' 'project,' 'predict,' 'should' and 'will' and similar expressions as they relate to the Company are intended to identify such forward-looking statements. These forward-looking statements are not guarantees of future performance; rather they are based on the Management's current expectations and assumptions about future events and trends, the economy and other future conditions. The forward-looking statements involve a number of known and unknown risks and uncertainties. These risks and uncertainties and other factors could materially adversely affect the outcome and financial effects of the plans and events described herein. The Company's results of operations, cash needs, financial condition, liquidity, prospects, future transactions, strategies or events may differ materially from those expressed or implied in such forward-looking statements and from expectations. As a result, no undue reliance should be placed on such forward-looking statements. This press release does not contain risk factors. Certain risk factors that may affect the Company's future financial results are discussed in the published annual financial statements of the Company. This press release, including any forward-looking statements, speaks only as of the date of this press release. The Company does not assume any obligation to update any information or forward-looking statements contained herein, save for any information required to be disclosed by law. For more information, please contact: Investor ContactsVivoryon Therapeutics Manuela Bader, Director IR & CommunicationEmail: IR@ LifeSci AdvisorsSandya von der Weid Tel: +41 78 680 05 38Email: svonderweid@ Media ContactTrophic CommunicationsValeria Fisher or Verena SchossmannTel: +49 175 8041816 / +49 151 219 412 77Email: vivoryon@ Attachment 250527_VVY US Patent Press Release_FINError in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data