Cholesterol

Aldeyra Therapeutics Provides Clinical and Regulatory Update and Announces Advancement of RASP Platform in Systemic and Retinal Inflammatory Diseases

Retrieved on: 
Thursday, January 4, 2024
FDA, Health, Clinical Trials, Pharmaceutical, Optical, Biotechnology, Alcoholism, Atopic dermatitis, Cholesterol, Metabolism, Multimedia, IND, Alcoholic hepatitis, Disease, Mortality, AMD, Body surface area, Therapy, MELD, Clinical trial, Hospital, Telecanthus, DSM-IV codes, Spasticity, Protocol, Cirrhosis, Biomarker, Triglyceride, Syndrome, Ethanol, Patient, Safety, RASP, Retina, Pharmaceutical industry

ADX-629, administered twice daily over 90 days, has completed initial clinical testing in three adult patients in an investigator-sponsored clinical trial.

Key Points: 
  • ADX-629, administered twice daily over 90 days, has completed initial clinical testing in three adult patients in an investigator-sponsored clinical trial.
  • Highlighting the advancement of the RASP platform and the selection of key clinical indications for future development, Aldeyra released a focused pipeline.
  • “With the success achieved in our ADX-629 program, which includes a number of positive, signal-finding clinical results, we are excited to advance our RASP modulator pipeline to systemic and retinal immune-mediated diseases, as well as metabolic diseases, exacerbated by RASP,” stated Dr. Brady.
  • “We anticipate 2024 to provide a variety of clinical-stage catalysts, as Aldeyra continues to progress its novel RASP platform.”

Human medicines European public assessment report (EPAR): Evkeeza, evinacumab, Date of authorisation: 17/06/2021, Revision: 3, Status: Authorised

Retrieved on: 
Tuesday, January 2, 2024
Medical Subject Headings, Marketing, LDL, Cholesterol, Artery, Anaphylaxis, Agency, INN, Adolescence, Atherosclerosis, Collection, ATC, Apolipoprotein, International, Diet, Ill, Disease, Ageing, Nose, Blood, Nausea, Language, Heart, Inflammation, Dizziness, Allergy, European Medicines Agency, Back pain, Enzyme, Select, Human, Patient, Safety, Cardiovascular disease, Fats, Anatomy, Medicine, ANGPTL3, IIA, Medical device

Human medicines European public assessment report (EPAR): Evkeeza, evinacumab, Date of authorisation: 17/06/2021, Revision: 3, Status: Authorised

Key Points: 


Human medicines European public assessment report (EPAR): Evkeeza, evinacumab, Date of authorisation: 17/06/2021, Revision: 3, Status: Authorised

"You Are What You Eat" Docuseries Features Prime Roots Plant-Based Meats Freshly Slicing at Delis Counters Near You

Retrieved on: 
Saturday, December 30, 2023
Cholesterol, Allergen, Koji, Nitrate, Meat, Hormone, Insulin, Health, Eating, Twin, Human, Grocery store

BERKELEY, Calif., Dec. 30, 2023 /PRNewswire/ -- Prime Roots, the leading innovator of freshly-sliced plant-based deli classics made from koji, is featured as a delicious innovation at the deli counter in final episode 4 of the "You Are What You Eat: A Twin Experiment" docuseries launching January 1, 2024. The docuseries follows four sets of twins whose diets diverge with one eating an omnivore diet and the other plant-based to see how key health indicators changed.

Key Points: 
  • The docuseries follows four sets of twins whose diets diverge with one eating an omnivore diet and the other plant-based to see how key health indicators changed.
  • The series was based on the recent Stanford Study that showed multiple benefits of eating plant-based after just four weeks of the diet change.
  • Plus, nutritionally, Prime Roots' products have protein, fiber, and do not contain nitrates, hormones, antibiotics, cholesterol, soy, top nine allergens, and are non-GMO and gluten-free.
  • Expanding rapidly in distribution, Prime Roots deli classics and charcuterie made from koji can currently be ordered in California, Oregon, and New York City and visit store finder for specific locations where Prime Roots products are available.

ZyVersa Therapeutics’ CEO, Stephen C. Glover, to Participate in BIO Partnering @ JPM During “J.P. Morgan Week 2024”

Retrieved on: 
Monday, December 18, 2023
Inflammation, Kidney, Cholesterol

During the conference, Mr. Glover will hold one-on-one meetings with pharmaceutical companies and investors to discuss ZyVersa’s business and clinical development strategy, recent corporate achievements, and anticipated milestones.

Key Points: 
  • During the conference, Mr. Glover will hold one-on-one meetings with pharmaceutical companies and investors to discuss ZyVersa’s business and clinical development strategy, recent corporate achievements, and anticipated milestones.
  • To schedule a meeting with Mr. Glover, please sign up in the conference portal or contact Karen Cashmere, Chief Commercial Officer at [email protected] .
  • “2024 is expected to be a pivotal year for ZyVersa as we plan to initiate a Phase 2a clinical trial with our Cholesterol Efflux Mediator™ VAR 200 in development to ameliorate renal lipid accumulation that damages the kidney’s filtration system leading to kidney dysfunction and disease progression,” said Mr. Glover.
  • “We look forward to meeting with industry strategics and investors during J.P. Morgan Week 2024 to discuss the value building opportunities expected with our VAR 200 program, as well as development plans for our proprietary Inflammasome ASC Inhibitor IC 100, which is designed to block initiation and perpetuation of damaging inflammation associated with a multitude of inflammatory diseases.”
    To learn more about ZyVersa and its innovative and differentiated product pipeline, please visit www.zyversa.com .

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.

Skye Announces Clinical Development Plan in Obesity for Differentiated Peripheral CB1 Inhibitor, Nimacimab

Retrieved on: 
Monday, December 11, 2023
GIP, NAFLD, Traffic barrier, Cholesterol, Food, Șaeș, IND, Non-alcoholic fatty liver disease, Drug discovery, FDA, Kidney disease, Weight loss, Syringe, Trial of the century, Half-life, Obesity, Investigational New Drug, Chronic kidney disease, OTCQB, CNS, CB1, Biomarker, Prediabetes, Central nervous system, Patient, Safety, Albuminuria, Pharmaceutical industry

SAN DIEGO, Dec. 11, 2023 (GLOBE NEWSWIRE) -- Skye Bioscience, Inc. (OTCQB: SKYE) ("Skye"), a pharmaceutical company developing drugs targeting the endocannabinoid system, announced today that it plans to develop nimacimab, the Company’s monoclonal antibody recently acquired from Bird Rock Bio, for weight loss and the treatment of obesity. The Company has filed an Investigational New Drug ("IND") application with the U.S. Food and Drug Administration ("FDA") for the initiation of a Phase 2 clinical study of nimacimab in patients with obesity and chronic kidney disease.

Key Points: 
  • Nimacimab is a negative-allosteric modulating antibody targeting the cannabinoid 1 receptor ("CB1"), which has been implicated as an important target in multiple cardiometabolic diseases including obesity and renal complications.
  • Obesity and kidney disease are highly correlated: 80% of patients who have kidney disease are also obese; 30% of obese patients have kidney disease.
  • Nimacimab effectively inhibits CB1 signaling and, based on preclinical and early clinical studies, is devoid of the CNS liabilities typically seen by small molecule drugs that target the CB1 receptor because it does not cross the blood-brain barrier.
  • Skye owns the worldwide rights to nimacimab, with patents issued in the U.S. and other territories including claims to cannabinoid 1 receptor antibodies with inverse agonist function.

ZyVersa Therapeutics Announces Publication Showing AIM2 and NLRP3 Inflammasomes Promote Atherosclerosis in Diabetes, Supporting IC 100’s Rationale for Targeting ASC to Inhibit Multiple Inflammasome Pathways

Retrieved on: 
Wednesday, December 6, 2023
Necrosis, Pyroptosis, Cholesterol, Artery, Inflammasome, Plasma, ASC, AIM2, Therapy, Inflammation, Stroke, Lipid, Animal, Patient, Plaque, Pharmaceutical industry

The study published in Diabetes demonstrates that AIM2 and NLRP3 inflammasome activation leads to development of atherosclerotic lesions in diabetic mice.

Key Points: 
  • The study published in Diabetes demonstrates that AIM2 and NLRP3 inflammasome activation leads to development of atherosclerotic lesions in diabetic mice.
  • ZyVersa is developing Inflammasome ASC Inhibitor IC 100, which inhibits multiple inflammasome pathways (including NLRP3 and AIM2) to attenuate initiation and perpetuation of damaging inflammation that is pathogenic in numerous diseases.
  • In the paper titled, “Hematopoietic NLRP3 and AIM2 inflammasomes promote diabetes-accelerated atherosclerosis, but increased necrosis is independent of pyroptosis,” the authors studied mouse models of type 1 diabetes and atherosclerosis.
  • Results are consistent with other animal model studies showing deficiencies in essential inflammasome components, such as NLRP3, AIM2, ASC, and caspase-1, appear to protect against atherosclerosis.

The Secret Behind MAA's Success: Why Cryogenic Spices Make a Huge Difference in the Kitchen

Retrieved on: 
Tuesday, December 19, 2023
MAA, Cholesterol, Food industry, Heat, Nutrient, Spice, Burns, MSG, Fast food

FORT LAUDERDALE, Fla., Dec. 19, 2023 /PRNewswire/ -- Harry "Guru" Khanna has spent years developing the greatest Indian sauces on the market. The recipes in each jar of MAA sauce were developed in a Toronto pub, perfected in India, and are low-fat, top-allergen safe, and free of additives, cholesterol, trans-fat, and MSG. While it is an impressive list, these benefits actually aren't the primary element that makes each of Khanna's sauces stand out. The truly differentiating factor behind the MAA label is its owner's use of cryogenic spices.

Key Points: 
  • FORT LAUDERDALE, Fla., Dec. 19, 2023 /PRNewswire/ -- Harry "Guru" Khanna has spent years developing the greatest Indian sauces on the market.
  • The truly differentiating factor behind the MAA label is its owner's use of cryogenic spices .
  • Cryogenic spices are a new and developing concept in the food industry, and Khanna has invested nearly eight years and half a million dollars into R&D to develop the perfect list of cryogenic spices.
  • Critically, the use of cryogenic spices ensures that the sauces themselves boast a fresher, more nutritious, and overall more wholesome flavor profile.

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.

Esperion Presents CLEAR Outcomes Analysis of Inflammation as Predictor of Cardiovascular Risk at American Heart Association Scientific Sessions 2023

Retrieved on: 
Monday, November 13, 2023
Disease, Esperion Therapeutics, Rash, Abdominal pain, AHA, Membrane protein, Patient, Bempedoic acid, PCSK9, CVD, Anemia, Angioedema, Rupture, Inflammation, Diet, Atherosclerosis, Safety, Incidence, FAHA, Mortality, Tablet, Health, Tendon rupture, Diarrhea, Harvard Medical School, Ezetimibe, Urinary tract infection, Fetus, Hypersensitivity, Arthralgia, Gout, American Heart Association, ESPR, Therapy, Sinusitis, Risk, Spasm, Constipation, MACE, Anaphylaxis, Pain, Moyamoya disease, Back pain, Upper respiratory tract infection, FACC, Flexner Report, CLEAR, Fatigue, Pregnancy, Kidney, Uric acid, MPH, ATP, Bronchitis, Hospital, Dietary supplement, Pharmaceutical industry, Vaccine, Common, Esperies, Brigham, Hyperuricemia, MD, Cholesterol

ANN ARBOR, Mich., Nov. 13, 2023 (GLOBE NEWSWIRE) -- Esperion (NASDAQ: ESPR) today announced the presentation of results from a pre-specified, exploratory analysis of CLEAR Outcomes at the 2023 American Heart Association (AHA) Scientific Sessions. Results were also simultaneously published in Circulation which can be accessed here.

Key Points: 
  • “In the future, it can be anticipated that virtually all atherosclerosis patients will receive aggressive inflammation inhibition along with aggressive cholesterol reduction,” Ridker added.
  • In CLEAR Outcomes, patients who were randomized to bempedoic acid experienced a 21.6% reduction in hsCRP compared to placebo at 6 months.
  • At Esperion, we discover, develop, and commercialize innovative medicines to help improve outcomes for patients with or at risk for cardiovascular and cardiometabolic diseases.
  • CLEAR Outcomes is part of the CLEAR clinical research program for NEXLETOL® (bempedoic acid) Tablet and NEXLIZET® (bempedoic acid and ezetimibe) Tablet.