Acute kidney injury

Saghmos Therapeutics Announces Notice of Allowance for Second US Patent for Phase 3-Ready Cardiorenal Metabolic Modulator ST-62516

Retrieved on: 
Wednesday, February 7, 2024
Cardiology, Biotechnology, Pharmaceutical, General Health, Health, FDA, Health Technology, Other Health, Acute kidney injury, MD, Percutaneous coronary intervention, AKI, IND, Patient, Safety, Trimetazidine, Ageing, CKD, Therapy, Diabetes, Risk, Patent, Chronic kidney disease, Unstable angina, PCI, Pharmaceutical industry

Saghmos Therapeutics, Inc. (Saghmos), a privately held biopharmaceutical company, announced a Notice of Allowance for a second US patent for its Phase 3-ready product, ST-62516 (trimetazidine), a cardiorenal metabolic modulator.

Key Points: 
  • Saghmos Therapeutics, Inc. (Saghmos), a privately held biopharmaceutical company, announced a Notice of Allowance for a second US patent for its Phase 3-ready product, ST-62516 (trimetazidine), a cardiorenal metabolic modulator.
  • "We are very pleased to announce the Notice of Allowance for our second patent, which will enhance the long-term value of ST-62516.
  • Saghmos continues to build its intellectual property estate,” commented Anna Kazanchyan, MD, Founder and CEO of Saghmos Therapeutics.
  • ST-62516 could benefit all PCI patients, not just those with comorbidities, to reduce the threat of AKI and MACKE after PCI.

Revelation Biosciences Inc. to Present at The International Conference on Advances in Critical Care Nephrology (AKI & CRRT 2024)

Retrieved on: 
Tuesday, January 30, 2024
Health, Clinical Trials, Research, Pharmaceutical, Science, Biotechnology, Senior, CRRT, AKI, Acute kidney injury, Toll-like receptor 4, TLR4, Conference

Revelation Biosciences Inc. (NASDAQ: REVB) (the “Company” or “Revelation”), announced today that new preclinical data on the potential therapeutic benefit of Gemini for the prevention of acute kidney injury (AKI) will be presented at the International Conference on Advances in Critical Care Nephrology (AKI & CRRT 2024) taking place in San Diego (March 12-15, 2024).

Key Points: 
  • Revelation Biosciences Inc. (NASDAQ: REVB) (the “Company” or “Revelation”), announced today that new preclinical data on the potential therapeutic benefit of Gemini for the prevention of acute kidney injury (AKI) will be presented at the International Conference on Advances in Critical Care Nephrology (AKI & CRRT 2024) taking place in San Diego (March 12-15, 2024).
  • Gemini is the Company’s proprietary formulation of phosphorylated hexaacyl disaccharide (PHAD®), a toll-like receptor 4 (TLR4) agonist, in development for prevention of AKI and hospital acquired infection.
  • Robin Marsden, Senior Vice President of Biology, Revelation Biosciences
    “We are delighted to have the opportunity to present our exciting preclinical data for the prevention of acute kidney injury (AKI),” said James Rolke, Chief Executive Officer of Revelation.
  • “We are grateful to the conference organizers for creating a forum for industry, academia, and key opinion leaders to share data and ideas in this critical area of medicine.”

Unicycive Therapeutics Announces Both an Oral and Poster Presentation to be Delivered on UNI-494 at the Upcoming AKI and CRRT Conference

Retrieved on: 
Monday, January 29, 2024
LOS, Patient, Therapy, MD, AKI, Kidney disease, Critical care, Conference, CRRT, Acute kidney injury, OLC, Kidney transplantation, Pharmaceutical industry

Shalabh Gupta, MD, Chief Executive Officer of Unicycive, commented, “We are looking forward to presenting data on the efficacy of our second clinical stage program UNI-494 in animal models of delayed graft function, a manifestation of acute kidney injury (AKI) that occurs during kidney transplantation resulting in loss of kidney function.

Key Points: 
  • Shalabh Gupta, MD, Chief Executive Officer of Unicycive, commented, “We are looking forward to presenting data on the efficacy of our second clinical stage program UNI-494 in animal models of delayed graft function, a manifestation of acute kidney injury (AKI) that occurs during kidney transplantation resulting in loss of kidney function.
  • We are also presenting a poster describing our ongoing Phase 1 clinical trial design for UNI-494 in healthy volunteers.
  • Based on the results from this trial, we will determine the best path forward for the program.
  • While our primary focus is on advancing our lead drug, OLC (Oxylanthanum Carbonate) towards a New Drug Application submission, we continue to build a body of data on UNI-494 as it progresses through its first clinical trial.”

Unicycive Therapeutics Issues Shareholder Letter to Highlight Corporate Progress and Key Upcoming Milestones

Retrieved on: 
Tuesday, January 23, 2024
CMC, LOS, Dialysis, Patient, Therapy, International Society of Nephrology, NKF, National Kidney Foundation, ATP, Agency, Hyperphosphatemia, American Journal, Acute kidney injury, Nephrology, Clutch (eggs), ISN, Trial of the century, Society, Kidney disease, Chronic kidney disease, Water, NDA, European Renal Association, HIV/AIDS, CKD, Conditional sentence, Heart, FDA, Tablet, ERA, Letter, Patent, International Society, Mitochondrial disease, Diabetes, Physician, Pharmaceutical industry

LOS ALTOS, Calif., Jan. 23, 2024 (GLOBE NEWSWIRE) -- Unicycive Therapeutics, Inc. (Nasdaq: UNCY), a clinical-stage biotechnology company developing therapies for patients with kidney disease (the “Company or “Unicycive”), today issued a letter to shareholders.

Key Points: 
  • As I sit down to write this letter, I am filled with a profound sense of gratitude and excitement, energized for the year ahead.
  • In this letter, I am pleased to recap for you another year of great accomplishments.
  • We’ve made significant advancements in our clinical programs which will propel us to new heights in 2024.
  • I would like to express my deep appreciation to the physician investigators, study participants, and especially to our dedicated Unicycive employees.

Prytime Medical Names Dr. M. Chance Spalding New Chief Medical Officer

Retrieved on: 
Friday, January 19, 2024
Mount Carmel Health System, Death, Patient, Trauma, SAN, Resuscitation, University, Medicine, Surgery, Biomedical engineering, Doctor of Philosophy, Bleeding, Human, Surgeon, Ohio University, REBOA, Center of excellence, Acute kidney injury, Physician, Growth

SAN ANTONIO, Jan. 19, 2024 /PRNewswire-PRWeb/ -- Prytime Medical Devices Inc, The REBOA Company™, the leading innovator and global provider of lifesaving REBOA products for minimally invasive, endovascular hemorrhage control and resuscitation, announced today the hiring of Chief Medical Officer, M. Chance Spalding, D.O., Ph.D., F.A.C.S.

Key Points: 
  • Additionally, he brings deep experience in clinical quality improvement, pREBOA-PRO™ programs, and teaching to lead Prytime Medical's global, clinical strategy.
  • SAN ANTONIO, Jan. 19, 2024 /PRNewswire-PRWeb/ -- Prytime Medical Devices Inc, The REBOA Company™, the leading innovator and global provider of lifesaving REBOA products for minimally invasive, endovascular hemorrhage control and resuscitation, announced today the hiring of Chief Medical Officer, M. Chance Spalding, D.O., Ph.D., F.A.C.S.
  • "I'm excited to join Prytime Medical at this important time in its growth and evolution.
  • I've seen how partial REBOA using the pREBOA-PRO™ catheter gives me time to treat patients who are severely hypotensive," said Dr. Spalding.

AM-Pharma Initiates Phase 2 Trial of Ilofotase Alfa for Cardiac Surgery-Associated Renal Damage

Retrieved on: 
Tuesday, January 16, 2024
Science, Cardiology, Biotechnology, Research, Pharmaceutical, Surgery, Health, Clinical Trials, MAKE, Patient, Enzyme replacement therapy, Incidence, MD, Kidney, HPP, Hypophosphatasia, Trial of the century, AKI, Risk, Phase II, Radboud University Medical Center, Safety, Renal replacement therapy, Doctor of Philosophy, Acute kidney injury, Experiment, Pharmaceutical industry

CSA-RD is defined as the long-term loss of renal function in cardiac surgery patients and arises from acute kidney injury (AKI) immediately following the surgery.

Key Points: 
  • CSA-RD is defined as the long-term loss of renal function in cardiac surgery patients and arises from acute kidney injury (AKI) immediately following the surgery.
  • Ilofotase alfa has a proven safety and tolerability profile and a strong record of renal protective effects as observed in previous clinical studies.
  • Notably, prior Phase 2 and Phase 3 trials with ilofotase alfa demonstrated significant improvements in Major Adverse Kidney Events by day 90 (MAKE90) in sepsis-associated AKI.
  • Ilofotase alfa was recently evaluated in a Phase 1b pilot study as enzyme replacement therapy in hypophosphatasia (HPP) patients.

Arch Biopartners Receives Health Canada Approval to Conduct Phase II Trial for LSALT Peptide Targeting Cardiac Surgery Associated-Acute Kidney Injury

Retrieved on: 
Wednesday, January 10, 2024
Mortality, Arch, Kidney, Patient, TMX Group, Ischemia, Reperfusion, Kidney disease, Oxygen, Yolo Bypass, Letter, Science Advances, AKI, Injury, Risk, CABG, OTCQB, Disease, Food, National Research Council, IRI, Acute kidney injury, Liver, Inflammation, Phase, Health Canada, Prevalence, Pharmaceutical industry

TORONTO, Jan. 10, 2024 (GLOBE NEWSWIRE) -- Arch Biopartners Inc. , (“Arch” or the “Company”) (TSX Venture: ARCH and OTCQB: ACHFF), announced today that it has received a No Objection Letter from Health Canada to conduct a Phase II trial for LSALT peptide, targeting the prevention and treatment of cardiac surgery-associated acute kidney injury (CS-AKI).

Key Points: 
  • TORONTO, Jan. 10, 2024 (GLOBE NEWSWIRE) -- Arch Biopartners Inc. , (“Arch” or the “Company”) (TSX Venture: ARCH and OTCQB: ACHFF), announced today that it has received a No Objection Letter from Health Canada to conduct a Phase II trial for LSALT peptide, targeting the prevention and treatment of cardiac surgery-associated acute kidney injury (CS-AKI).
  • LSALT peptide is the Company’s lead drug candidate for preventing and treating inflammation injury in the kidneys, lungs and liver.
  • The Phase II trial is an international multi-center, randomized, double-blind, placebo-controlled study of LSALT peptide.
  • There is no treatment available in the market today that prevents acute kidney injury of the type commonly experienced by on-pump cardiac surgery patients.

Lexicon Pharmaceuticals Provides Business and Pipeline Update at 42nd Annual J.P. Morgan Healthcare Conference

Retrieved on: 
Monday, January 8, 2024
Lithium, UGT, Risk, Digoxin, Shanda, Hypotension, FDA, SGLT1, Type 2 diabetes, Acute kidney injury, Congress, Pyelonephritis, Conference, Fever, Ketoacidosis, Pregabalin, Pregnancy, Pain, Assessment, Gabapentin, Tenderness, New Drug Application, Amber Grid, HCM, Common, SGLT2, PROGRESS, Hypertrophic cardiomyopathy, Diabetes, Kidney, Heart failure, Dialysis, History, Patient, Prescription, Type, Neuropathic pain, Webcast, Insulin, T2DM, EGFR, Erythema, T1DM, Hypoglycemia, Partnership, Contraindication, Diarrhea, NDA, Incidence, Swelling, Urinary tract infection, Hospital, Chronic kidney disease, Internationalized domain name, Metabolic acidosis, Creatinine, Growth, Lactation, Pharmaceutical industry

THE WOODLANDS, Texas, Jan. 08, 2024 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX), a biopharmaceutical company with a mission of pioneering medicines that transform patients’ lives, today announced a business and pipeline update at the 42nd Annual J.P. Morgan Healthcare Conference taking place January 8-12, 2024.

Key Points: 
  • THE WOODLANDS, Texas, Jan. 08, 2024 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX), a biopharmaceutical company with a mission of pioneering medicines that transform patients’ lives, today announced a business and pipeline update at the 42nd Annual J.P. Morgan Healthcare Conference taking place January 8-12, 2024.
  • “Lexicon achieved major advancements in 2023 in its business and pipeline of pharmaceutical innovations,” said Lonnel Coats, chief executive officer and director of Lexicon.
  • The company will also focus on ensuring a strong ongoing awareness of INPEFA in the medical community through medical publications and congress presence.
  • Company to Present at J.P. Morgan Healthcare Conference Thursday, January 11, 2024 at 10:30am PST (1:30pm ET)
    Lonnel Coats, Lexicon’s chief executive officer, will make a company presentation.

Arch Biopartners Receives Approval from the Turkish Ministry of Health to Proceed with Phase II Trial for LSALT Peptide Targeting Cardiac Surgery Associated-Acute Kidney Injury

Retrieved on: 
Wednesday, January 3, 2024
Liver, Arch, AKI, Risk, Reperfusion, IRI, Prevalence, Disease, Mortality, TMX Group, Science Advances, Inflammation, National Research Council, Oxygen, Acute kidney injury, OTCQB, CABG, Ministry, Health Canada, Kidney, Injury, Patient, Ischemia, MOH, Pharmaceutical industry

TORONTO, Jan. 03, 2024 (GLOBE NEWSWIRE) -- Arch Biopartners Inc. , (“Arch” or the “Company”) (TSX Venture: ARCH and OTCQB: ACHFF), announced today that it has received approval in Turkey from the Ministry of Health to proceed with a Phase II trial for LSALT peptide, targeting the prevention and treatment of cardiac surgery-associated acute kidney injury (CS-AKI).

Key Points: 
  • TORONTO, Jan. 03, 2024 (GLOBE NEWSWIRE) -- Arch Biopartners Inc. , (“Arch” or the “Company”) (TSX Venture: ARCH and OTCQB: ACHFF), announced today that it has received approval in Turkey from the Ministry of Health to proceed with a Phase II trial for LSALT peptide, targeting the prevention and treatment of cardiac surgery-associated acute kidney injury (CS-AKI).
  • LSALT peptide is the Company’s lead drug candidate for preventing and treating inflammation injury in the kidneys, lungs and liver.
  • With the Ministry of Health (MoH) approval for the trial, Arch can now proceed to contract and activate clinical sites in Turkey.
  • Once blood flow is restored to normal (reperfusion), inflammation is triggered and injury to kidney cells is exacerbated.

SeaStar Medical Updates Subject Enrollment in its Pivotal Trial with the Selective Cytopheretic Device in Adults with Acute Kidney Injury

Retrieved on: 
Thursday, December 28, 2023
SCD, Quality of life, AKI, FDA, HDE, MD, Clinical trial, Food and Drug Administration, Acute kidney injury, Patient, Safety, Dialysis, CKRT, Sepsis, Pharmaceutical industry

DENVER, Dec. 28, 2023 (GLOBE NEWSWIRE) -- SeaStar Medical Holding Corporation (Nasdaq: ICU), a medical device company developing proprietary solutions to reduce the consequences of hyperinflammation on vital organs, announces enrollment of 12 subjects in the NEUTRALIZE-AKI pivotal clinical trial evaluating the safety and efficacy of its patented, first-in-class, cell-directed Selective Cytopheretic Device (SCD) extracorporeal therapy in critically ill adults with acute kidney injury (AKI) requiring continuous kidney replacement therapy (CKRT).

Key Points: 
  • DENVER, Dec. 28, 2023 (GLOBE NEWSWIRE) -- SeaStar Medical Holding Corporation (Nasdaq: ICU), a medical device company developing proprietary solutions to reduce the consequences of hyperinflammation on vital organs, announces enrollment of 12 subjects in the NEUTRALIZE-AKI pivotal clinical trial evaluating the safety and efficacy of its patented, first-in-class, cell-directed Selective Cytopheretic Device (SCD) extracorporeal therapy in critically ill adults with acute kidney injury (AKI) requiring continuous kidney replacement therapy (CKRT).
  • “Over the past six weeks we have enrolled five subjects in this clinical trial while also continuing progress in activating additional clinical sites,” said Kevin Chung, MD, Chief Medical Officer of SeaStar Medical.
  • “We are grateful to the dedicated investigators and their research staff who are working diligently to help validate the efficacy and safety of the SCD in this vulnerable population.”
    “We look forward to providing periodic updates on patient enrollment and site activations as this important trial progresses,” said Eric Schlorff, CEO of SeaStar Medical.
  • “We believe the more than 200,000 U.S. adult patients each year with AKI who require CKRT deserve a better treatment option.