Diabetic nephropathy

ZyVersa Therapeutics Reports Full Year 2023 Financial Results and Provides Business Update

Retrieved on: 
Monday, March 25, 2024
Research, Diabetic nephropathy, Cholesterol, Obesity, Institutional review board, Patient, Protocol, MJFF, University, IND, IRB, Investigational New Drug, Therapy, Atherosclerosis, Metabolic syndrome, Government, Inflammasome, Pharmaceutical industry

WESTON, Fla., March 25, 2024 (GLOBE NEWSWIRE) -- ZyVersa Therapeutics, Inc. (Nasdaq: ZVSA, or “ZyVersa”), a clinical-stage specialty biopharmaceutical company developing first-in-class drugs for the treatment of renal and inflammatory diseases with high unmet medical needs, reports financial results for full year ending December 31, 2023, and provides business update.

Key Points: 
  • Scientific collaboration to assess Inflammasome ASC Inhibitor IC 100 as a potential treatment for atherosclerosis expected to conclude H1-2024.
  • WESTON, Fla., March 25, 2024 (GLOBE NEWSWIRE) -- ZyVersa Therapeutics, Inc. (Nasdaq: ZVSA, or “ZyVersa”), a clinical-stage specialty biopharmaceutical company developing first-in-class drugs for the treatment of renal and inflammatory diseases with high unmet medical needs, reports financial results for full year ending December 31, 2023, and provides business update.
  • “Throughout 2023 and early 2024, ZyVersa achieved considerable progress in advancing development of our two lead candidates.
  • The impairment is a result of the decline in stock value and the resulting market capitalization of ZyVersa during the 2023 Period.

ZyVersa Therapeutics Announces IRB Approval of Phase 2a Clinical Trial Protocol to Evaluate Cholesterol Efflux Mediator™ VAR 200 in Patients with Diabetic Kidney Disease

Retrieved on: 
Monday, March 18, 2024
Alport syndrome, Diabetic nephropathy, VAR, Institutional review board, Lipid, Patient, Focal segmental glomerulosclerosis, Kidney disease, Fibrosis, Clinical trial, Kidney, Therapy, Chronic kidney disease, Safety, Dialysis, Cholesterol, IRB, Pharmaceutical industry

Cholesterol Efflux MediatorTM VAR 200 is in development to ameliorate renal lipid accumulation that damages the kidneys’ filtration system, leading to chronic kidney disease and its progression.

Key Points: 
  • Cholesterol Efflux MediatorTM VAR 200 is in development to ameliorate renal lipid accumulation that damages the kidneys’ filtration system, leading to chronic kidney disease and its progression.
  • WESTON, Fla., March 18, 2024 (GLOBE NEWSWIRE) -- ZyVersa Therapeutics, Inc. (Nasdaq: ZVSA, or “ZyVersa”), a clinical stage specialty biopharmaceutical company developing first-in-class drugs for the treatment of renal and inflammatory diseases with high unmet medical needs, announces Institutional Review Board (IRB) approval of the Phase 2a clinical trial protocol to evaluate the efficacy and safety of Cholesterol Efflux Mediator VAR 200 in patients with diabetic kidney disease.
  • It is the first in human trial for VAR 200 intended to substantiate that the promising preclinical results demonstrated in three different animal models of kidney disease (diabetic kidney disease, focal segmental glomerulosclerosis, and Alport syndrome) translate to patients with kidney disease.
  • We are excited about the potential of Cholesterol Efflux MediatorTM VAR 200 to protect against kidney injury and reduce kidney disease progression.”

RemeGen's Telitacicept (RC18) Granted Fast Track Designation by United States FDA for Treatment of Primary Sjögren's Syndrome

Retrieved on: 
Wednesday, April 3, 2024
Rheumatoid arthritis, Autoimmunity, Lupus, Risk, Rheumatism, Patient, PSS, SLE, Diabetic nephropathy, Myasthenia gravis, IND, Mouth, Investigational New Drug, Cytokine, B-cell activating factor, Iga, FDA, FTD

The FDA grants FTD to accelerate the development and review of new drugs that have the potential to treat life-threatening conditions and address unmet medical needs.

Key Points: 
  • The FDA grants FTD to accelerate the development and review of new drugs that have the potential to treat life-threatening conditions and address unmet medical needs.
  • Telitacicept prevents abnormal differentiation and maturation of B-cells through a two-pronged approach, thereby treating various autoimmune diseases mediated by B-cells.
  • In December 2023, Telitacicept was granted Investigational New Drug (IND) by the FDA for the treatment of active pSS in adults.
  • Dr. Jianmin Fang, CEO of RemeGen, commented, "As the first fusion protein drug of its kind independently developed by RemeGen, we are delighted the FDA has recognized Telitacicept for fast track designation.

ZyVersa Therapeutics' CEO, Stephen C. Glover to Present at the 2024 BIO CEO & Investor Conference to Provide Corporate Update and Discuss Key Milestones

Retrieved on: 
Wednesday, February 7, 2024
Diabetic nephropathy, Patient, BIO, Entrepreneurship, CNS, Therapy, Inflammasome, Kidney, Conference, Pharmaceutical industry

WESTON, Fla., Feb. 07, 2024 (GLOBE NEWSWIRE) -- ZyVersa Therapeutics, Inc. (Nasdaq: ZVSA, or “ZyVersa”), a clinical stage specialty biopharmaceutical company developing first-in-class drugs for the treatment of renal and inflammatory diseases with high unmet medical needs, announces that Stephen C. Glover, Co-Founder, Chairman, Chief Executive Officer, and President, will provide a corporate update as an invited speaker at the BIO CEO & Investor Conference to be held in New York February 26 – 27, 2024.

Key Points: 
  • WESTON, Fla., Feb. 07, 2024 (GLOBE NEWSWIRE) -- ZyVersa Therapeutics, Inc. (Nasdaq: ZVSA, or “ZyVersa”), a clinical stage specialty biopharmaceutical company developing first-in-class drugs for the treatment of renal and inflammatory diseases with high unmet medical needs, announces that Stephen C. Glover, Co-Founder, Chairman, Chief Executive Officer, and President, will provide a corporate update as an invited speaker at the BIO CEO & Investor Conference to be held in New York February 26 – 27, 2024.
  • Mr. Glover will discuss upcoming development milestones for Cholesterol Efflux MediatorTM VAR 200, for which a Phase 2a clinical trial in patients with diabetic kidney disease is planned to begin this quarter, and for Inflammasome ASC Inhibitor IC 100, which is nearing completion of its preclinical program.
  • To learn more about ZyVersa and its robust development pipeline, please schedule a one-on-one meeting with Mr. Glover through the BIO conference portal.
  • Details regarding Mr. Glover’s presentation are as follows:

JDRF Awards $9 Million US for Phase 3 Type 1 Diabetes Kidney Disease Clinical Trial, Joins The Kidney Foundation of Canada in Driving Research to Treat Kidney Disease

Retrieved on: 
Monday, January 22, 2024
Diabetes, Patient, Research, Diabetic nephropathy, Kidney, Kidney failure, Person, T1D, CIHR, SGLT2, Team, University, Kidney disease, Joslin Diabetes Center, Risk, KFOC, Type 2 diabetes, Safety, Public, University of Toronto, SGLT, JDRF, Clinical trial, University Health Network, Pharmaceutical industry

Kidney disease remains a life-threatening complication for those living with diabetes.

Key Points: 
  • Kidney disease remains a life-threatening complication for those living with diabetes.
  • Almost half of kidney failure cases are caused by diabetes, and an estimated one out of three people with T1D develop significant kidney disease.
  • SUGARNSALT is one of the largest T1D focused kidney disease studies in the world, and it is the only phase 3 clinical trial targeting major kidney disease outcomes.
  • "The Kidney Foundation of Canada is proud to be one of the founding partners on this significant investment to support innovative strategies to treat diabetic kidney disease.

New published data demonstrates KidneyIntelX™ has broad implications for winning war on chronic kidney disease

Retrieved on: 
Wednesday, January 10, 2024
Diabetes, RWE, American Heart Association, Patient, Diabetic nephropathy, Kidney, MD, Hypertension, Risk assessment, Type 2 diabetes, Insurance, Heart failure, Risk, Food, Chronic kidney disease, Real world evidence, CKD, Community health, FDA, Doctor of Philosophy, BMI, Real, EGFR, Marketing, Physician, Pharmaceutical industry

LONDON and SALT LAKE CITY, Jan. 10, 2024 (GLOBE NEWSWIRE) -- Renalytix plc (NASDAQ: RNLX) (LSE: RENX) announces publication of Real World Evidence (“RWE”) after 12 months of follow-up in 2,569 patients with Type 2 diabetes and diabetic kidney disease (“DKD”) at a major U.S. health system in Primary Care and Community Health. Results in the diverse cohort, including 27% black patients, demonstrate that electronic health record deployment of KidneyIntelX in vitro prognostic testing was associated with clinical actions that led to a significant slowing of chronic kidney disease progression and improved Type 2 diabetes control most notably in the highest risk patients.

Key Points: 
  • Improved kidney health was evidenced by reduction in the rate of kidney function decline (eGFR slope) and diabetes control was evidenced by improved A1C levels.
  • KidneyIntelX testing achieved scale through electronic health record integration, deploying directly to large treating groups of primary care physicians.
  • KidneyIntelX has received broad insurance payment coverage including through Medicare, Medicaid, and Blue Cross Blue Shield programs.
  • “The demonstrated benefits of KidneyIntelX early risk assessment at one year are significant and go to the core of chronic disease preventative medicine.

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.

Palatin Provides Corporate Update and Highlights Strategic Priorities for Calendar Year 2024

Retrieved on: 
Monday, January 8, 2024
DED, HSDD, Probability, Sale, PDE5, Weight loss, UC, Trial of the century, PTN, Calendar, Obesity, Patient, Therapy, Female, Diabetic nephropathy, Erectile dysfunction, Pharmaceutical industry

"We made significant operational progress during calendar year 2023 and we believe we are well-positioned for making calendar year 2024 a pivotal and transformative year for Palatin," said Carl Spana, Ph.D., President and CEO of Palatin.

Key Points: 
  • "We made significant operational progress during calendar year 2023 and we believe we are well-positioned for making calendar year 2024 a pivotal and transformative year for Palatin," said Carl Spana, Ph.D., President and CEO of Palatin.
  • Topline data readout for our Phase 3 PL9643 clinical study for DED is expected early in the first quarter of calendar year 2024.
  • We expect to commence a Phase 2 clinical study of a MCR4 agonist plus a GLP-1 in obese patients in the first quarter of calendar year 2024.
  • The recently announced divestiture of Vyleesi is consistent with Palatin's strategic decision to concentrate on its robust development and clinical pipeline.

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.