Latest news with #DKD
Yahoo
12 hours ago
- Health
- Yahoo
BioCity's SC0062 gains NMPA breakthrough therapy designation
The Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA) has granted BioCity's endothelin receptor type A (ETA) antagonist, SC0062, a second breakthrough therapy designation (BTD). This new designation is intended to treat diabetic kidney disease (DKD) with albuminuria and highlights the therapy's potential for chronic kidney disease indications. The BTD was supported by data from the DKD cohort of the Phase II 2-SUCCEED trial, and SC0062 showed major reductions in albuminuria at the 20mg dose against placebo. The safety profile was favourable both as monotherapy and when combined with treatments such as SGLT2 inhibitors, GLP-1 receptor agonists, RAAS inhibitors, insulin and Finerenone. BioCity co-founder and executive president Dr Ivy Wang stated: 'With over 700 million people affected globally, kidney disease represents one of our greatest unmet medical challenges. 'This dual BTD recognition validates SC0062's potential to redefine treatment paradigms across renal diseases. We're accelerating development to deliver this promising therapy to patients worldwide.' The completed 2-SUCCEED programme achieved all efficacy and safety endpoints at 12 and 24-week timepoints for both Immunoglobulin A nephropathy (IgAN) and DKD cohorts. SC0062 may slow CKD progression compared to non-selective treatments while minimising side effects. Preclinical studies have shown that it significantly improved pathological scores in acute and CKD models. The therapy has completed Phase I trials, demonstrating good tolerability, safety and pharmacokinetics without signs of fluid retention. It has now concluded enrolment for both IgAN and DKD cohorts in the Phase II 2-SUCCEED study and the cohorts have met their primary endpoints. With these developments underway, BioCity is initiating two Phase III clinical trials that include SUCCESS-01 (IgAN) and SUCCESS-02 (CKD). "BioCity's SC0062 gains NMPA breakthrough therapy designation" was originally created and published by Pharmaceutical Technology, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site. 登入存取你的投資組合
Associated Press
17 hours ago
- Business
- Associated Press
ZyVersa Therapeutics Announces First Clinical Site Activation, Initiating Patient Recruitment for Cholesterol Efflux Mediator™ VAR 200's Phase 2a Clinical Trial in Patients with Diabetic Kidney Disease (DKD)
WESTON, Fla., June 26, 2025 (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 that the Clinical Advancement Center, PLLC in San Antonio, Texas is the first clinical site activated and ready for patient recruitment in our VAR 200 Phase 2a clinical study in patients with DKD. The lead investigator is Pablo Pergola, MD, PhD. 'We are pleased to work with Dr. Pergola and his research colleagues at the Clinical Advancement Center to kick off our first-in-human VAR 200 Phase 2a trial in patients with DKD. We share a similar vision to that of Dr. Pergola and the Clinical Advancement Center – to develop innovative treatments that will change the course of kidney disease and improve patients' quality of life,' said Stephen C. Glover, ZyVersa's Co-founder, Chairman, CEO, and President. 'It is this vision that led us to develop a drug, VAR 200, that targets a neglected pathogenic pathway in kidney disease – excess accumulation of cholesterol and lipids in the glomerulus, the main filtering unit of the kidney. There is a large body of evidence demonstrating the critical need for therapies to address kidney lipotoxicity, a key pathway in development and progression of DKD and other kidney diseases. Despite newer treatment options for kidney disease, over 130,000 patients progress to renal failure each year in the US, and more than 800,000 patients are living with renal failure requiring dialysis or transplant to sustain life. We believe that adding VAR 200 to standard-of-care drugs, like ACEs, ARBs, and SGLT2 inhibitors that address other pathogenic pathways, will be disease-modifying and better protect against further kidney injury and disease progression. We look forward to seeing the results of this Phase 2a trial, and to progressing VAR 200 to commercialization.' VAR 200's proof-of-concept Phase 2a study will be conducted at one to two US sites and will enroll an adequate number of subjects to complete eight. It is a 16-week open-label study (12 weeks of treatment and a four-week follow-up period) to evaluate the drug's efficacy and safety in patients with type 2 diabetes and diabetic kidney disease with proteinuria. VAR 200 will be administered intravenously twice weekly at a single dose and will be added to the stable drug regimen used by each patient. The primary efficacy endpoint is percent change from baseline to week 12 in urinary albumin to creatinine ratio. Further details can be found at ABOUT CHOLESTEROL EFFLUX MEDIATOR™ VAR 200 Cholesterol Efflux Mediator™ VAR 200 (2-hydroxypropyl-beta-cyclodextrin, 2HPβCD) is an injectable drug in phase 2 development to ameliorate renal lipid accumulation that damages the kidneys' filtration system, leading to development and progression of kidney disease. VAR 200 removes excess lipids from the kidney both passively, and actively by upregulation of cholesterol efflux transporters, ABCA1 and ABCG. Preclinical studies with VAR 200 in animal models of FSGS, Alport syndrome, and diabetic kidney disease demonstrate reduced levels of cholesterol and lipids, protection against renal injury and fibrosis, and improvement in proteinuria. Additional information can be found in the VAR 200 White Paper. The lead indication for VAR 200 is orphan kidney disease, focal segmental glomerulosclerosis (FSGS). Prior to initiating a Phase 2a trial in patients with FSGS, we are conducting a small Phase 2a trial in patients with diabetic kidney disease, which we expect will provide patient proof-of-concept more quickly than an FSGS study. Alport Syndrome and diabetic kidney disease indications may be pursued based on our indication expansion strategy. ABOUT ZYVERSA THERAPEUTICS, INC. ZyVersa (Nasdaq: ZVSA) is a clinical stage specialty biopharmaceutical company leveraging advanced, proprietary technologies to develop first-in-class drugs for patients with renal and inflammatory diseases who have significant unmet medical needs. The Company is currently advancing a therapeutic development pipeline with multiple programs built around its two proprietary technologies – Cholesterol Efflux Mediator™ VAR 200 for treatment of kidney diseases, and Inflammasome ASC Inhibitor IC 100, targeting damaging inflammation associated with numerous CNS and peripheral inflammatory diseases. For more information, please visit CAUTIONARY STATEMENT REGARDING FORWARD-LOOKING STATEMENTS Certain statements contained in this press release regarding matters that are not historical facts, are forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995. These include statements regarding management's intentions, plans, beliefs, expectations, or forecasts for the future, and, therefore, you are cautioned not to place undue reliance on them. No forward-looking statement can be guaranteed, and actual results may differ materially from those projected. ZyVersa Therapeutics, Inc. ('ZyVersa') uses words such as 'anticipates,' 'believes,' 'plans,' 'expects,' 'projects,' 'future,' 'intends,' 'may,' 'will,' 'should,' 'could,' 'estimates,' 'predicts,' 'potential,' 'continue,' 'guidance,' and similar expressions to identify these forward-looking statements that are intended to be covered by the safe-harbor provisions. Such forward-looking statements are based on ZyVersa's expectations and involve risks and uncertainties; consequently, actual results may differ materially from those expressed or implied in the statements due to a number of factors, including ZyVersa's plans to develop and commercialize its product candidates, the timing of initiation of ZyVersa's planned preclinical and clinical trials; the timing of the availability of data from ZyVersa's preclinical and clinical trials; the timing of any planned investigational new drug application or new drug application; ZyVersa's plans to research, develop, and commercialize its current and future product candidates; the clinical utility, potential benefits and market acceptance of ZyVersa's product candidates; ZyVersa's commercialization, marketing and manufacturing capabilities and strategy; ZyVersa's ability to protect its intellectual property position; and ZyVersa's estimates regarding future revenue, expenses, capital requirements and need for additional financing. New factors emerge from time-to-time, and it is not possible for ZyVersa to predict all such factors, nor can ZyVersa assess the impact of each such factor on the business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements. Forward-looking statements included in this press release are based on information available to ZyVersa as of the date of this press release. ZyVersa disclaims any obligation to update such forward-looking statements to reflect events or circumstances after the date of this press release, except as required by applicable law. This press release does not constitute an offer to sell, or the solicitation of an offer to buy, any securities. Corporate, IR, and Media Contact Karen Cashmere Chief Commercial Officer [email protected] 786-251-9641
Sydney Morning Herald
20-06-2025
- Health
- Sydney Morning Herald
Proteomics flags US rollout of kidney test at global diabetes summit
ASX-listed diagnostics disruptor Proteomics International has officially launched its innovative kidney disease test, PromarkerD, in the massive United States healthcare market. The launch took place at the American Diabetes Association's 85th scientific sessions talkfest in Chicago. The annual conference marks the world's largest gathering of diabetes experts, making it the ideal stage to unveil PromarkerD to the US market. PromarkerD is a simple predictive blood test capable of identifying a person's risk of developing diabetic kidney disease (DKD) up to four years before symptoms appear, offering a potential lifeline to the more than 32 million Americans living with type 2 diabetes. According to clinical studies, the patented test accurately predicted kidney function decline in up to 86 per cent of patients who otherwise showed no symptoms. 'This marks a significant milestone in our global commercialisation strategy.' Proteomics International managing director Dr Richard Lipscombe More than half of all adults with diabetes in the US will develop kidney complications. These cases contribute to a colossal US$130 billion in annual healthcare costs - more than a quarter of the nation's Medicare budget. Proteomics International managing director Dr Richard Lipscombe said: 'We're excited to introduce PromarkerD to the US at such a prestigious event. This marks a significant milestone in our global commercialisation strategy and underscores our commitment to addressing the diabetes epidemic through precision medicine.' The PromarkerD rollout will begin in California, supported by the company's recently commissioned CLIA-certified testing laboratory in Irvine. US patients will be able to access the test from Proteomics International's integrated digital health platform. The sales model was piloted in Australia and designed to support direct-to-consumer and clinical engagement. Renowned diabetes professional Davida Kruger, from Henry Ford Health in Detroit, called the test 'a paradigm shift in diabetes care.' Kruger noted early identification of at-risk patients means doctors can use preventive strategies long before irreversible damage occurs.
The Age
20-06-2025
- Health
- The Age
Proteomics flags US rollout of kidney test at global diabetes summit
ASX-listed diagnostics disruptor Proteomics International has officially launched its innovative kidney disease test, PromarkerD, in the massive United States healthcare market. The launch took place at the American Diabetes Association's 85th scientific sessions talkfest in Chicago. The annual conference marks the world's largest gathering of diabetes experts, making it the ideal stage to unveil PromarkerD to the US market. PromarkerD is a simple predictive blood test capable of identifying a person's risk of developing diabetic kidney disease (DKD) up to four years before symptoms appear, offering a potential lifeline to the more than 32 million Americans living with type 2 diabetes. According to clinical studies, the patented test accurately predicted kidney function decline in up to 86 per cent of patients who otherwise showed no symptoms. 'This marks a significant milestone in our global commercialisation strategy.' Proteomics International managing director Dr Richard Lipscombe More than half of all adults with diabetes in the US will develop kidney complications. These cases contribute to a colossal US$130 billion in annual healthcare costs - more than a quarter of the nation's Medicare budget. Proteomics International managing director Dr Richard Lipscombe said: 'We're excited to introduce PromarkerD to the US at such a prestigious event. This marks a significant milestone in our global commercialisation strategy and underscores our commitment to addressing the diabetes epidemic through precision medicine.' The PromarkerD rollout will begin in California, supported by the company's recently commissioned CLIA-certified testing laboratory in Irvine. US patients will be able to access the test from Proteomics International's integrated digital health platform. The sales model was piloted in Australia and designed to support direct-to-consumer and clinical engagement. Renowned diabetes professional Davida Kruger, from Henry Ford Health in Detroit, called the test 'a paradigm shift in diabetes care.' Kruger noted early identification of at-risk patients means doctors can use preventive strategies long before irreversible damage occurs.
Scotsman
09-05-2025
- Sport
- Scotsman
Former Hearts and Wigan ace offered contract at English club with free agency lurking
Watch more of our videos on and on Freeview 262 or Freely 565 Visit Shots! now He has spent this season with Barnsley after time with the likes of Hearts and Wigan. Sign up to our Hearts newsletter Sign up Thank you for signing up! Did you know with a Digital Subscription to Edinburgh News, you can get unlimited access to the website including our premium content, as well as benefiting from fewer ads, loyalty rewards and much more. Learn More Sorry, there seem to be some issues. Please try again later. Submitting... A former Hearts and Wigan star has been offered an extended stay at English League One level. Stephen Humphrys has been with Barnsley throughout this campaign after leaving Wigan Athletic and has impressed over his 41 outings, with nine goals. There was an option to extend the one year deal he signed last summer but as of yet, there has been no official word on whether he will stay at Oakwell beyond this summer. Advertisement Hide Ad Advertisement Hide Ad As part of their end of season retained list though, it has been confirmed an extension has been offered. Humphrys proved a fan favourite at Hearts during his loan at the club in the 22/23 season, scoring five times in 25 games, including a memorable strike from range against Dundee United. Former Hearts star offered contract Ex-Hearts loanee Dexter Lembikisa, who was at the club last campaign from Wolves, has returned to his parent club at Molineux. A club statement reads: 'Barnsley FC extends its sincere thanks to all departing players for their efforts during their time at Oakwell and wishes them every success in their future endeavours. Further updates regarding contract negotiations will be shared in due course.' Humphrys said recently of his role at Barnsley: 'I feel like my role in this team is different to any role that I've had in the past. Chances don't come as much for me as they do for DKD (Davis Keillor-Dunn). The deeper players kind of get more of the chances, but I feel like a lot of the chances come off the back of the work that I've been doing at the top of the pitch. I feel like I've become more of a provider, chance creator, kind of gap maker, if that makes sense, I've been making the runs in behind and trying to do the more selfless stuff. 'I really don't care who scores, you know, DKD is one of my best mates here so the fact that he's flying and scoring goals makes me happy, as long as we're winning games. A lot of people will be focusing on goal droughts, this, that and the other but when you win three games in a row, like we've just done, you don't even think about who scores. It's been something different for me, but I mean I've probably said it in a previous interview, I don't really care where I am, as long as I'm on the pitch starting. Advertisement Hide Ad Advertisement Hide Ad 'Last year, I was predominantly a winger, last year, I was receiving the ball, I never had anyone behind my back, and I always had the touchline at my back, so I knew I had the whole pitch in front of me, I felt like I had a lot more time, whereas now it's, hold the ball up, there's always a man coming behind you. 'I've got to compete for headers more, which I feel like I've improved on my heading and making runs in behind, which as a winger, you don't really do, so it's just adapting to that, but like I said, as long as I'm on the pitch, I really don't mind, but hopefully a few chances do start coming my way. I mean, last season, I was used to having, six, seven ,eight, shots a game sometimes, now I don't have a shot, but that's just part of the role that I'm playing at the minute. As long as we're getting positive results, I really don't mind.'
