Latest news with #TXNIP
Yahoo
29-05-2025
- Business
- Yahoo
TIXiMED Announces Successful Completion of a Phase 1 Study of its Novel Oral Disease-Modifying Type 1 Diabetes Therapy
TIX100 Demonstrates Safety and Tolerability in Human Subjects, Marking a Key Drug Development Milestone Post-Hoc Analysis Reveals Promising First Biological TIX100 Signal in Humans TIXiMED to Advance TIX100 to Multiple Ascending Dose Studies BIRMINGHAM, Ala., May 29, 2025--(BUSINESS WIRE)--TIXiMED, Inc. ( a clinical-stage pharmaceutical company developing a novel disease-modifying oral therapy for type 1 diabetes (T1D), today announced the successful completion of the Phase 1 Single Ascending Dose (SAD) study for TIX100. This first human trial confirmed that TIX100 was safe and well-tolerated across all tested dose levels in healthy subjects. Additionally, post-hoc analysis revealed decreased postprandial blood glucose excursion and improved glucose homeostasis after a standardized liquid meal in the two highest dose cohorts, providing the first evidence of a biological TIX100 effect in humans. "We are thrilled with the successful completion of the Phase 1 SAD study, which demonstrated the safety and tolerability of TIX100 in humans," said Dr. Anath Shalev, Founder and Chief Scientific Officer at TIXiMED. "We are also excited that, despite the small sample size and healthy study population, a promising metabolic TIX100 signal became evident at the human dose predicted in preclinical models," Dr. Shalev added. "These findings also suggest that stronger effects might be observed in people with diabetes and bring TIXiMED closer to delivering a novel oral therapy that addresses the underlying causes of T1D, offering hope for improved outcomes for patients across all stages of the disease." This double-blind, randomized, placebo-controlled Phase 1 SAD study evaluated the safety, tolerability, and pharmacokinetics of TIX100 at escalating doses in 28 healthy adults. Clinical and laboratory results demonstrated no drug-related adverse events, no ECG changes and no hypoglycemia with TIX100 exhibiting a favorable safety profile and predictable pharmacokinetics, supporting progression to the next phase of clinical development. TIX100 is an oral drug that targets thioredoxin-interacting protein (TXNIP), a detrimental protein that is elevated in people with diabetes and leads to beta cell death and pancreatic islet dysfunction. TXNIP inhibition has been demonstrated in mouse models and in humans with T1D to protect the body's own insulin-producing beta cells while promoting overall islet cell health. TIX100 has also been shown to reduce unnecessary glucose production from the liver. TIX100 is a potent and specific TXNIP inhibitor designed to target these underlying disease mechanisms and has been shown to be highly efficacious in preventing and reversing diabetes in pre-clinical studies. Building on these results, TIXiMED is now preparing to initiate a Phase 1 Multiple Ascending Dose (MAD) study to further assess longer-term TIX100 safety, tolerability, and pharmacokinetics over multiple doses in healthy subjects. "Clinical advancement of innovative therapies addressing the fundamental biological causes of T1D is exciting, and supporting these efforts is critical to preventing and delaying T1D disease progression," says Dr. Ben Williams, Program Officer at The Leona M. and Harry B. Helmsley Charitable Trust. "The unique target product profile and mechanism of TIX100 positions it as a promising candidate to transform T1D management," said Steve Daly, CEO of TIXiMED. "We are inspired by these results and excited to advance to the MAD study, continuing our mission to address the unmet needs of people living with T1D." About TIXiMED TIXiMED is a pharmaceutical company dedicated to developing and commercializing a first-of-its kind oral therapy for type 1 diabetes based on inhibition of the protein TXNIP. TIXiMED is the exclusive license holder for the patent surrounding TIX100, a novel, small molecule TXNIP inhibitor, and its derivatives, which has been shown to protect against models of type 1 and type 2 diabetes as well as metabolic dysfunction–associated steatotic liver disease. Visit for more information. The Helmsley Charitable Trust made a Program Related Investment in the form of a loan to support this project. View source version on Contacts Emma BoldenEmail: Emma@ Phone: +1.949.939.8771Website: Error 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
Business Wire
29-05-2025
- Health
- Business Wire
TIXiMED Announces Successful Completion of a Phase 1 Study of its Novel Oral Disease-Modifying Type 1 Diabetes Therapy
BIRMINGHAM, Ala.--(BUSINESS WIRE)-- TIXiMED, Inc. ( a clinical-stage pharmaceutical company developing a novel disease-modifying oral therapy for type 1 diabetes (T1D), today announced the successful completion of the Phase 1 Single Ascending Dose (SAD) study for TIX100. This first human trial confirmed that TIX100 was safe and well-tolerated across all tested dose levels in healthy subjects. Additionally, post-hoc analysis revealed decreased postprandial blood glucose excursion and improved glucose homeostasis after a standardized liquid meal in the two highest dose cohorts, providing the first evidence of a biological TIX100 effect in humans. Building on these results, TIXiMED is now preparing to initiate a Phase 1 Multiple Ascending Dose study to further assess longer-term TIX100 safety, tolerability, and pharmacokinetics over multiple doses in healthy subjects. Share 'We are thrilled with the successful completion of the Phase 1 SAD study, which demonstrated the safety and tolerability of TIX100 in humans,' said Dr. Anath Shalev, Founder and Chief Scientific Officer at TIXiMED. 'We are also excited that, despite the small sample size and healthy study population, a promising metabolic TIX100 signal became evident at the human dose predicted in preclinical models,' Dr. Shalev added. 'These findings also suggest that stronger effects might be observed in people with diabetes and bring TIXiMED closer to delivering a novel oral therapy that addresses the underlying causes of T1D, offering hope for improved outcomes for patients across all stages of the disease.' This double-blind, randomized, placebo-controlled Phase 1 SAD study evaluated the safety, tolerability, and pharmacokinetics of TIX100 at escalating doses in 28 healthy adults. Clinical and laboratory results demonstrated no drug-related adverse events, no ECG changes and no hypoglycemia with TIX100 exhibiting a favorable safety profile and predictable pharmacokinetics, supporting progression to the next phase of clinical development. TIX100 is an oral drug that targets thioredoxin-interacting protein (TXNIP), a detrimental protein that is elevated in people with diabetes and leads to beta cell death and pancreatic islet dysfunction. TXNIP inhibition has been demonstrated in mouse models and in humans with T1D to protect the body's own insulin-producing beta cells while promoting overall islet cell health. TIX100 has also been shown to reduce unnecessary glucose production from the liver. TIX100 is a potent and specific TXNIP inhibitor designed to target these underlying disease mechanisms and has been shown to be highly efficacious in preventing and reversing diabetes in pre-clinical studies. Building on these results, TIXiMED is now preparing to initiate a Phase 1 Multiple Ascending Dose (MAD) study to further assess longer-term TIX100 safety, tolerability, and pharmacokinetics over multiple doses in healthy subjects. 'Clinical advancement of innovative therapies addressing the fundamental biological causes of T1D is exciting, and supporting these efforts is critical to preventing and delaying T1D disease progression,' says Dr. Ben Williams, Program Officer at The Leona M. and Harry B. Helmsley Charitable Trust. 'The unique target product profile and mechanism of TIX100 positions it as a promising candidate to transform T1D management,' said Steve Daly, CEO of TIXiMED. 'We are inspired by these results and excited to advance to the MAD study, continuing our mission to address the unmet needs of people living with T1D.' About TIXiMED TIXiMED is a pharmaceutical company dedicated to developing and commercializing a first-of-its kind oral therapy for type 1 diabetes based on inhibition of the protein TXNIP. TIXiMED is the exclusive license holder for the patent surrounding TIX100, a novel, small molecule TXNIP inhibitor, and its derivatives, which has been shown to protect against models of type 1 and type 2 diabetes as well as metabolic dysfunction–associated steatotic liver disease. Visit for more information. The Helmsley Charitable Trust made a Program Related Investment in the form of a loan to support this project.
Yahoo
29-05-2025
- Business
- Yahoo
TIXiMED Announces Successful Completion of a Phase 1 Study of its Novel Oral Disease-Modifying Type 1 Diabetes Therapy
TIX100 Demonstrates Safety and Tolerability in Human Subjects, Marking a Key Drug Development Milestone Post-Hoc Analysis Reveals Promising First Biological TIX100 Signal in Humans TIXiMED to Advance TIX100 to Multiple Ascending Dose Studies BIRMINGHAM, Ala., May 29, 2025--(BUSINESS WIRE)--TIXiMED, Inc. ( a clinical-stage pharmaceutical company developing a novel disease-modifying oral therapy for type 1 diabetes (T1D), today announced the successful completion of the Phase 1 Single Ascending Dose (SAD) study for TIX100. This first human trial confirmed that TIX100 was safe and well-tolerated across all tested dose levels in healthy subjects. Additionally, post-hoc analysis revealed decreased postprandial blood glucose excursion and improved glucose homeostasis after a standardized liquid meal in the two highest dose cohorts, providing the first evidence of a biological TIX100 effect in humans. "We are thrilled with the successful completion of the Phase 1 SAD study, which demonstrated the safety and tolerability of TIX100 in humans," said Dr. Anath Shalev, Founder and Chief Scientific Officer at TIXiMED. "We are also excited that, despite the small sample size and healthy study population, a promising metabolic TIX100 signal became evident at the human dose predicted in preclinical models," Dr. Shalev added. "These findings also suggest that stronger effects might be observed in people with diabetes and bring TIXiMED closer to delivering a novel oral therapy that addresses the underlying causes of T1D, offering hope for improved outcomes for patients across all stages of the disease." This double-blind, randomized, placebo-controlled Phase 1 SAD study evaluated the safety, tolerability, and pharmacokinetics of TIX100 at escalating doses in 28 healthy adults. Clinical and laboratory results demonstrated no drug-related adverse events, no ECG changes and no hypoglycemia with TIX100 exhibiting a favorable safety profile and predictable pharmacokinetics, supporting progression to the next phase of clinical development. TIX100 is an oral drug that targets thioredoxin-interacting protein (TXNIP), a detrimental protein that is elevated in people with diabetes and leads to beta cell death and pancreatic islet dysfunction. TXNIP inhibition has been demonstrated in mouse models and in humans with T1D to protect the body's own insulin-producing beta cells while promoting overall islet cell health. TIX100 has also been shown to reduce unnecessary glucose production from the liver. TIX100 is a potent and specific TXNIP inhibitor designed to target these underlying disease mechanisms and has been shown to be highly efficacious in preventing and reversing diabetes in pre-clinical studies. Building on these results, TIXiMED is now preparing to initiate a Phase 1 Multiple Ascending Dose (MAD) study to further assess longer-term TIX100 safety, tolerability, and pharmacokinetics over multiple doses in healthy subjects. "Clinical advancement of innovative therapies addressing the fundamental biological causes of T1D is exciting, and supporting these efforts is critical to preventing and delaying T1D disease progression," says Dr. Ben Williams, Program Officer at The Leona M. and Harry B. Helmsley Charitable Trust. "The unique target product profile and mechanism of TIX100 positions it as a promising candidate to transform T1D management," said Steve Daly, CEO of TIXiMED. "We are inspired by these results and excited to advance to the MAD study, continuing our mission to address the unmet needs of people living with T1D." About TIXiMED TIXiMED is a pharmaceutical company dedicated to developing and commercializing a first-of-its kind oral therapy for type 1 diabetes based on inhibition of the protein TXNIP. TIXiMED is the exclusive license holder for the patent surrounding TIX100, a novel, small molecule TXNIP inhibitor, and its derivatives, which has been shown to protect against models of type 1 and type 2 diabetes as well as metabolic dysfunction–associated steatotic liver disease. Visit for more information. The Helmsley Charitable Trust made a Program Related Investment in the form of a loan to support this project. View source version on Contacts Emma BoldenEmail: Emma@ Phone: +1.949.939.8771Website: Error 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
Yahoo
10-05-2025
- Health
- Yahoo
Cell death and disease study by Institute scientists Sheds light on targeted protein to fight breast cancer
May 9—Roughly 1 in 8 women will be diagnosed with invasive breast cancer over their lifetimes, according to the American Cancer Society—and for the year 2024, it was estimated that more than 300,000 women in the United States would be diagnosed with breast cancer, and more than 40,000 would die from the disease. If we want to reduce these numbers, increasing our understanding of how breast cancer operates in order to improve prevention, detection, and treatment methods is paramount. The lab of Assistant Professor Liang Liu, PhD, at The Hormel Institute, University of Minnesota, has published a paper appearing in the scientific journal Cell Death & Disease that examines how a protein called TXNIP might help fight breast cancer by slowing its growth and spread throughout the body. The scientists focused on two different types of breast cancer cells: MDA-MB-231: Associated with triple-negative breast cancer and naturally high TXNIP levels HCC-1954: Associated with HER2-positive breast cancer, low TXNIP levels They also investigated how TXNIP interacts with other proteins—especially calpastatin (CAST) and interleukin-24 (IL-24)—and how these interactions influence a cancer-promoting cellular signal called STAT3. The study yielded some surprising findings that warrant further scientific exploration. "It's surprising that calpastatin (CAST), a protein TXNIP binds to, actually promotes tumor growth in both cell types tested. CAST was known for a different role (stopping cell damage), so its cancer-helping behavior here is unexpected and worth exploring further," Liu said. "In HCC-1954 cells, extra TXNIP first shrank tumors, but after four weeks, growth sped up. This shift hints that cancer might adapt or resist over time, possibly due to CAST, making TXNIP's effects a puzzle to solve." This study is significant for its contributions to understanding TXNIP's role in breast cancer and its therapeutic potential The study's authors are continuing research in this area to bring these findings closer to real-world use to transform outcomes for breast cancer patients. Beyond cancer, better understanding of TXNIP has applications across multiple health fields. For example, TXNIP helps regulate blood sugar and cell stress, making it significant in diabetes research. The Hormel Institute's Post-Doctoral Associate Jasvinder Singh, PhD; Post-Doctoral Associate Bindeshwar Sah; and Executive Director Robert Clarke, PhD, at The Hormel Institute are also listed as authors of the paper.
Associated Press
08-03-2025
- Business
- Associated Press
TIXiMED Inc. Announces Successful Dosing of First Cohort in the Phase 1 Clinical Trial of TIX100, its Investigational Disease-Modifying Treatment for Type 1 Diabetes
TIXiMED Inc. ( a clinical-stage pharmaceutical company based on the breakthrough discovery that TXNIP plays an important role in the development and progression of diabetes, today announced successful dosing of the first dose cohort in the Phase 1 Single Ascending Dose (SAD) trial of TIX100, its investigational novel oral therapy targeting beta cell health and islet cell function. Additionally, based on the safety review meeting, it was recommended that the randomized, placebo-controlled quadruple-blind clinical trial continue with no modifications and the next cohort escalate to the pre-specified dose level. ' We are pleased to achieve this significant milestone in the development of TIX100 with this first-in-human trial,' said Dr. Anath Shalev, TIXiMED Founder and Chief Scientific Officer. ' We look forward to evaluating the findings of the next, higher dose cohorts in the coming months and to a successful completion of the SAD trial later this year,' Dr. Shalev added. ' We have seen increasing recognition of the promise of TIX100 to one day improve the lives of people with type 1 diabetes,' said TIXiMED President and Board Chair Mike Goodrich. ' This first-in-human trial is the cornerstone of the clinical work we've planned to advance this novel therapy. We are very thankful to our investors and partners, including The Helmsley Charitable Trust, who made a program-related investment in the form of a loan to TIXiMED,' Mr. Goodrich concluded. About TIXiMED Inc. TIXiMED is a clinical stage pharmaceutical company dedicated to developing and commercializing a first-of-its kind oral therapy for type 1 diabetes based on TXNIP inhibition. TIXiMED is the exclusive license holder for the patent surrounding TIX100, a novel, small molecule TXNIP inhibitor, and its derivatives, that has been shown to protect against models of type 1 and type 2 diabetes as well as metabolic dysfunction–associated steatotic liver disease. Visit for more information. +1.205.578.1005 SOURCE: TIXiMED Inc. Copyright Business Wire 2025. PUB: 03/07/2025 09:00 PM/DISC: 03/07/2025 09:00 PM
