DKD

ZyVersa Therapeutics’ CEO, Stephen C. Glover, Featured on Benzinga All Access

Retrieved on: 
Wednesday, January 10, 2024
Entrepreneurship, Patient, Therapy, Proteinuria, Diabetic nephropathy, Toxicology, GLP, Interview, Structural Damage, Initial public offering, Kidney disease, Environment, Optimism, IND, Inflammasome, Inflammation, VAR, Investigational New Drug, DKD, Pharmaceutical industry

During the interview, Mr. Glover described the significant unmet need and market opportunity in kidney disease, and how ZyVersa’s Cholesterol Efflux MediatorTM VAR 200 has the potential to improve kidney function and reduce kidney disease progression.

Key Points: 
  • During the interview, Mr. Glover described the significant unmet need and market opportunity in kidney disease, and how ZyVersa’s Cholesterol Efflux MediatorTM VAR 200 has the potential to improve kidney function and reduce kidney disease progression.
  • Current treatments target glomerular hypertension and inflammation, but there are no treatments that target lipid accumulation, which is known to contribute to structural damage, proteinuria, and progression of kidney disease.
  • ZyVersa plans to initiate a Phase 2a trial with VAR 200 in patients with diabetic kidney disease (DKD) in the first quarter of 2024, with preliminary data anticipated by mid-year 2024.
  • ZyVersa plans to complete GLP toxicology studies with IC 100 and submit an Investigational New Drug (IND) application in the fourth quarter of 2024, followed by initiation of a Phase 1 trial.

Use of SGLT2 Inhibitors Continues to Expand for the Treatment of Chronic Kidney Disease, with Eli Lilly/Boehringer Ingelheim’s Jardiance Making Significant Strides Following Label Expansion

Retrieved on: 
Wednesday, January 3, 2024
Kidney, MRAS, AstraZeneca, Physician, Kidney disease, DMC, Nephrology, Weight loss, Prevalence, BMI, FLOW, Bayer, Diabetic nephropathy, Novo Nordisk, Chronic kidney disease, Proteinuria, Data monitoring committee, Patient, Obesity, MRA, DKD, ACE, SGLT2, Dialysis, CKD, Pharmaceutical industry

As the landscape grows more competitive, their role will be crucial in determining the success of brands like Farxiga and Jardiance.

Key Points: 
  • As the landscape grows more competitive, their role will be crucial in determining the success of brands like Farxiga and Jardiance.
  • This unique positioning compared to other agents was swiftly recognized by nephrologists, prompting them to express a clear preference for the brand.
  • Since the label expansion of Eli Lilly/Boehringer Ingelheim's Jardiance to include CKD, nephrologists have rapidly embraced this drug for both their DKD and non-diabetic CKD patients.
  • Several of these agents, including SGLT2 inhibitors and Kerendia, have demonstrated their effectiveness in slowing the progression of CKD.

ZyVersa Therapeutics CEO, Stephen C. Glover, Issues Letter to Shareholders Providing Outlook for 2024

Retrieved on: 
Wednesday, January 3, 2024
Alport syndrome, Quality of life, Entrepreneurship, Inflammasome, NLRP1, Survival, IND, VAR, Letter, Kidney disease, Inflammation, FSGS, AIM2, Health, Human, Therapy, Clinical trial, Diabetic nephropathy, Focal segmental glomerulosclerosis, Kidney, Proteinuria, NLRP3, DKD, ACE, Optimism, SGLT2, Patient, Capital, Fibrosis, Dialysis, Environment, Pharmaceutical industry

Combined, our two proprietary product platforms target a global total addressable market of around $75 billion.

Key Points: 
  • Combined, our two proprietary product platforms target a global total addressable market of around $75 billion.
  • On the financial front, various market watchers are seeing signals that the biotech and pharma investment environment is set to trend positively in 2024.
  • Capital is again starting to flow to companies that are seeking to innovate through differentiated technologies or novel mechanisms of action.
  • We look forward to embarking on what we believe will be a productive 2024.

ZyVersa Therapeutics Engages CRO, George Clinical, for Phase 2a Clinical Trial for Cholesterol Efflux Mediator VAR 200

Retrieved on: 
Thursday, December 14, 2023
Cholesterol, VAR, Therapy, Clinical trial, Focal segmental glomerulosclerosis, Chronic kidney disease, DKD, Patient, Safety, Diabetic nephropathy, Pharmaceutical industry

WESTON, Fla., Dec. 14, 2023 (GLOBE NEWSWIRE) -- ZyVersa Therapeutics, Inc. (Nasdaq: ZVSA; “ZyVersa”), a clinical stage specialty biopharmaceutical company developing first-in-class drugs for treatment of patients with renal and inflammatory diseases who have unmet medical needs, announces selection of contract research organization (“CRO”) George Clinical to manage its Phase 2a clinical trial with Cholesterol Efflux MediatorTM VAR 200 in patients with diabetic kidney disease (DKD).

Key Points: 
  • WESTON, Fla., Dec. 14, 2023 (GLOBE NEWSWIRE) -- ZyVersa Therapeutics, Inc. (Nasdaq: ZVSA; “ZyVersa”), a clinical stage specialty biopharmaceutical company developing first-in-class drugs for treatment of patients with renal and inflammatory diseases who have unmet medical needs, announces selection of contract research organization (“CRO”) George Clinical to manage its Phase 2a clinical trial with Cholesterol Efflux MediatorTM VAR 200 in patients with diabetic kidney disease (DKD).
  • The clinical trial is expected to begin in the first quarter of 2024.
  • George Clinical, who combines scientific and clinical leadership with expert trial delivery to create distinctive world-class solutions, was the recipient of Citeline’s 2023 Clinical Research Team of the Year.
  • “Initiation of the Phase 2a trial in patients with DKD marks a major milestone in the development of Cholesterol Efflux MediatorTM VAR 200 and for ZyVersa.

ZyVersa Therapeutics Announces Publication Demonstrating That Plasma Levels of NLRP3 Inflammasomes Correlate with Progression of Diabetic Kidney Disease in Patients with Type 2 Diabetes

Retrieved on: 
Thursday, December 7, 2023
NLRP3, DKD, Diabetic nephropathy, Medicine, Plasma, Inflammasome, Survival, Kidney disease, Dialysis, Type 2, Pharmaceutical industry

Diabetic kidney disease (DKD), which affects around 240 million people with Type 2 diabetes worldwide, is the leading cause of end-stage renal disease, which requires dialysis or kidney transplant for survival.

Key Points: 
  • Diabetic kidney disease (DKD), which affects around 240 million people with Type 2 diabetes worldwide, is the leading cause of end-stage renal disease, which requires dialysis or kidney transplant for survival.
  • Data suggest that early DKD intervention with inflammasome inhibitors has potential to attenuate disease progression.
  • In the paper titled, “Correlation Between Plasma NLRP3, IL-1β, and IL-18 and Diabetic Nephropathy in Patients With Type 2 Diabetes,” the authors evaluated the plasma of 152 patients with type 2 diabetes and DKD stratified by stage of disease (stages 1-5) and 30 patients with type 2 diabetes without kidney disease who serve as controls.
  • The data published in Alternative Therapies suggest that early DKD intervention with inflammasome inhibitors has potential to help attenuate disease progression.”

ZyVersa Therapeutics Reports Third Quarter 2023 Corporate Update and Financial Results

Retrieved on: 
Tuesday, November 14, 2023
Research, GLP, Therapy, Toxicology, IND, Inflammasome, Clinical trial, Cholesterol, Tissue, Patient, ASC, Lipid, Marketing, VAR, Growth, NLRP3, Diabetic nephropathy, DKD, Government, Inflammation, Pharmaceutical industry, Vaccine, Cryptocurrency

WESTON, Fla., Nov. 14, 2023 (GLOBE NEWSWIRE) -- ZyVersa Therapeutics, Inc. (Nasdaq: ZVSA; “ZyVersa”), a clinical stage specialty biopharmaceutical company developing first-in-class drugs for treatment of patients with renal and inflammatory diseases who have unmet medical needs, today provides a corporate update, and reports financial results for the third quarter of 2023 ending September 30, 2023.

Key Points: 
  • WESTON, Fla., Nov. 14, 2023 (GLOBE NEWSWIRE) -- ZyVersa Therapeutics, Inc. (Nasdaq: ZVSA; “ZyVersa”), a clinical stage specialty biopharmaceutical company developing first-in-class drugs for treatment of patients with renal and inflammatory diseases who have unmet medical needs, today provides a corporate update, and reports financial results for the third quarter of 2023 ending September 30, 2023.
  • “The third quarter of 2023 marks substantial progress toward meeting a key milestone at ZyVersa, initiation of the first clinical trial with Cholesterol Efflux Mediator™ VAR 200 in patients with diabetic kidney disease, planned for Q1-2024.
  • Since its inception in 2014 through September 30, 2023, ZyVersa has not generated any revenue and has incurred significant operating losses and negative cash flows from its operations.
  • The net loss improvement was primarily due to lower costs incurred in connection with our research and development programs.

Journey Biosciences Named a "Rising Star" Quarterfinalist in Prestigious Digital Health Awards

Retrieved on: 
Tuesday, September 5, 2023
Diabetes, LAUNCH (Innovation Challenge), Rising Star, Moonshot, Quality of life, Multimedia, Mentorship, Kidney disease, DCB, Digital health, Patient, UCSF, AI, DKD, Dietary supplement, Consumer electronics, Pharmaceutical industry, Nursing

CLEVELAND, Sept. 5, 2023 /PRNewswire/ -- Journey Biosciences, a digital health company specializing in predictive clinical screenings and expert lab analysis, has been named a "Rising Star" quarterfinalist in the diagnostic platform category for the Digital Health Hub Foundation - Digital Health Awards 2023. These awards recognize innovative companies driving significant change in healthcare through digital technologies.

Key Points: 
  • CLEVELAND, Sept. 5, 2023 /PRNewswire/ -- Journey Biosciences, a digital health company specializing in predictive clinical screenings and expert lab analysis, has been named a "Rising Star" quarterfinalist in the diagnostic platform category for the Digital Health Hub Foundation - Digital Health Awards 2023 .
  • Thanks to the Digital Health Hub Foundation team for recognizing Journey's transformative potential in healthcare," said Adam Graybill, CEO and Co-Founder of Journey Biosciences.
  • Journey joined StartUp Health's T1D Moonshot earlier this year and is excited to be a HLTH sponsor in the StartUp Health Pavilion.
  • About Digital Health Hub Foundation:
    Our mission is to help the world's next best innovative healthcare companies scale and grow.

Hua Medicine Announces 2023 Interim Results

Retrieved on: 
Friday, August 25, 2023
IGT, DREAM, National Healthcare Security Administration, Rat, Type 2 diabetes, Diabetes, Obesity, Progress, Hong Kong Exchanges and Clearing, Hospital, Patient, NGT, Fructose, American Diabetes Association, ADA, Disease, Pharmacy, Drug discovery, DSM-IV codes, Pancreas, Research, Homeostasis, Kidney, PPG, FKI, Liver, Growth, IND, Fatty liver disease, Endocrinology, DPP-4, Stroke, Chinese University of Hong Kong, MAH, Type 2, Metformin, CUHK, IVD, STA, DKD, Glucokinase, Probability, Metabolism, Liver disease, GK, Nature Communications, SEED, Trial of the century, TIR, Plasma protein binding, GKA, National Healthcare, Physician, AI, Bank, NRDL, Medicine, Congenital hyperinsulinism, Medical device, Pharmaceutical industry, Cryptocurrency, Bayer, T2D

Hua Medicine (the "Company", HKEx: 2552) today announces the unaudited consolidated results of the Company and its subsidiaries for the six months ended June 30, 2023 (the "Reporting Period").

Key Points: 
  • Hua Medicine (the "Company", HKEx: 2552) today announces the unaudited consolidated results of the Company and its subsidiaries for the six months ended June 30, 2023 (the "Reporting Period").
  • Dr. Li Chen, the founder and CEO of Hua Medicine, said, "the first half of 2023 was a critical stage for Hua Medicine to begin commercialization.
  • The revenue of Hua Medicine for the first half of 2023 was RMB70.3 million, which was an increase of approximately 299.6% comparing to the second half of 2022.
  • This article contains the statements regarding the future expectations, plans and prospects for Hua Medicine and the investigational product.

ZyVersa Therapeutics Reports Second Quarter 2023 Corporate and Financial Results

Retrieved on: 
Monday, August 21, 2023
University of Massachusetts, Marketing, Clinical trial, Neil, Research, Moyamoya disease, CNS, Inflammasome, Government, Juvenile idiopathic arthritis, Professor, Alcoholic hepatitis, Investigational New Drug, Patient, Division, Lupus nephritis, Immunology, DKD, Diabetic nephropathy, Therapy, Infection, Inflammation, Pharmaceutical industry, Vaccine, Cryptocurrency

WESTON, Fla., Aug. 21, 2023 (GLOBE NEWSWIRE) -- ZyVersa Therapeutics, Inc. (Nasdaq-GM: ZVSA; “ZyVersa”), a clinical stage specialty biopharmaceutical company developing first-in-class drugs for treatment of patients with renal and inflammatory diseases who have unmet medical needs, today provides a corporate update and reports financial results for the second quarter of 2023 ending June 30, 2023.

Key Points: 
  • “The second quarter of 2023 was a period of continued progress at ZyVersa as we completed key corporate, developmental, regulatory and financial initiatives designed to position the company to achieve value-building milestones involving our Cholesterol Efflux Mediator™ VAR 200 and Inflammasome ASC Inhibitor IC 100,” said Stephen C. Glover, Co-founder, Chairman, Chief Executive Officer, and President of ZyVersa.
  • “We are pleased to report our VAR 200 program is progressing as planned, and we anticipate initiation of a Phase 2a clinical trial in diabetic kidney disease (DKD) in the first quarter of 2024.
  • The increase is primarily attributable to an increase of $0.5 million in the costs of manufacturing of IC 100.
  • The impairment is a result of the decline in ZyVersa’s market capitalization as of June 30, 2023.

Renalytix Clinical Advisory Board Formed to Support Broadening Use of KidneyintelX.dkd

Retrieved on: 
Thursday, August 3, 2023
LSE, Chronic kidney disease, Life, Education, Hines, Quality of life, Type 2 diabetes, Loyola University, SALT, SGLT2, Associate, Dialysis, Ageing, Nephrology, Patient, Guideline, Practitioner, Physician, Risk, DKD, Research, Diabetic nephropathy, FDA, American Association of Clinical Endocrinologists, MPH, CKD, Loyola University Chicago, Kidney disease, Hypertension, Pharmaceutical industry

The confluence of new diagnostic technology, such as kidneyintelX.dkd, and new effective drug therapies, including SGLT2 inhibitors, has swung the door wide open to prevent millions of people from experiencing the life changing effects of uncontrolled kidney disease.

Key Points: 
  • The confluence of new diagnostic technology, such as kidneyintelX.dkd, and new effective drug therapies, including SGLT2 inhibitors, has swung the door wide open to prevent millions of people from experiencing the life changing effects of uncontrolled kidney disease.
  • Clinical actions are most effective for preserving kidney and cardiovascular health in DKD stages 1-3 before significant and irreversible kidney function loss has occurred.
  • Renalytix will engage with the Clinical Advisory Board to provide an urgent call to action for primary care clinicians to diagnose, risk assess and treat their patients with stage 1-3 CKD, specifically in type 2 diabetics.
  • The board will also advise the Company on education and outreach activities to promote adoption of best practices in kidney disease management, appropriate coordination with specialists including nephrologists and endocrinologists, and guideline recommendations.