Lipoprotein

Arrowhead Pharmaceuticals Presents New Phase 2 Data of Zodasiran in Patients with Mixed Hyperlipidemia

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水曜日, 5月 29, 2024

Arrowhead Pharmaceuticals, Inc. (NASDAQ: ARWR) today announced results from the Phase 2b double blind, randomized ARCHES-2 study of investigational zodasiran (formerly ARO-ANG3) in patients with mixed hyperlipidemia.

Key Points: 
  • Arrowhead Pharmaceuticals, Inc. (NASDAQ: ARWR) today announced results from the Phase 2b double blind, randomized ARCHES-2 study of investigational zodasiran (formerly ARO-ANG3) in patients with mixed hyperlipidemia.
  • Zodasiran was associated with robust and durable reductions in triglycerides, triglyceride rich lipoprotein remnants, and total atherogenic lipoproteins, including LDL-C.
  • These data were presented in a late-breaking oral presentation today at the European Atherosclerosis Society (EAS) 92nd Congress and simultaneously published in the New England Journal of Medicine .
  • Zodasiran demonstrated a favorable safety profile in patients with mixed hyperlipidemia in the ARCHES-2 study.

Arrowhead Pharmaceuticals Presents New Phase 2 Data of Plozasiran in Patients with Mixed Hyperlipidemia

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火曜日, 5月 28, 2024

Arrowhead Pharmaceuticals, Inc. (NASDAQ: ARWR) today announced results from the Phase 2b double blind, randomized MUIR study of investigational plozasiran (formerly ARO-APOC3) in patients with mixed hyperlipidemia.

Key Points: 
  • Arrowhead Pharmaceuticals, Inc. (NASDAQ: ARWR) today announced results from the Phase 2b double blind, randomized MUIR study of investigational plozasiran (formerly ARO-APOC3) in patients with mixed hyperlipidemia.
  • These data were presented in an oral presentation today at the European Atherosclerosis Society (EAS) 92nd Congress and simultaneously published in the New England Journal of Medicine .
  • “Despite advances in treatment, patients with mixed hyperlipidemia have elevated and persistent ASCVD risk due in part to high levels of atherogenic triglyceride rich lipoproteins.
  • Arrowhead is also presenting data from the SHASTA-2 study of plozasiran and the ARCHES-2 study of zodasiran (formerly ARO-ANG3) at EAS.

Akero Therapeutics Reports Fourth Quarter and Full Year 2023 Financial Results and Provides Business Update

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木曜日, 2月 29, 2024

SYNCHRONY Histology is evaluating the safety and efficacy of 28 and 50mg doses of efruxifermin (EFX) in patients with biopsy confirmed pre-cirrhotic MASH (F2-F3).

Key Points: 
  • SYNCHRONY Histology is evaluating the safety and efficacy of 28 and 50mg doses of efruxifermin (EFX) in patients with biopsy confirmed pre-cirrhotic MASH (F2-F3).
  • Additional patients will be enrolled and followed for long-term clinical outcomes to support an application for full marketing approval.
  • In the fourth quarter of 2023, Akero reported results for the week 36 analysis of the Phase 2b SYMMETRY study in patients with cirrhosis due to MASH.
  • Akero's cash, cash equivalents, short-term and long-term marketable securities for the year ended December 31, 2023 were $569.3 million.

Madrigal Pharmaceuticals Announces Publication of the Phase 3 MAESTRO-NASH Trial of Resmetirom in the New England Journal of Medicine

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木曜日, 2月 8, 2024

NASH is a leading cause of liver-related mortality and an increasing burden on healthcare systems globally.

Key Points: 
  • NASH is a leading cause of liver-related mortality and an increasing burden on healthcare systems globally.
  • Resmetirom received Breakthrough Therapy designation from the FDA and is under review to become the first medicine approved to treat patients with NASH with liver fibrosis.
  • Approximately 50% of patients treated with resmetirom 100 mg with biopsies at Week 52 showed either NASH resolution or fibrosis improvement.
  • More than 80% of patients with biopsies at Week 52 had either fibrosis reversal or no progression of fibrosis.

Akero Therapeutics Reports Third Quarter 2023 Financial Results and Provides Business Update

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月曜日, 11月 13, 2023

SOUTH SAN FRANCISCO, Calif., Nov. 13, 2023 (GLOBE NEWSWIRE) -- Akero Therapeutics, Inc. (Nasdaq: AKRO), a clinical-stage company developing transformational treatments for patients with serious metabolic diseases marked by high unmet medical need, today reported third quarter financial results for the period ending September 30, 2023 and provided business updates.

Key Points: 
  • SOUTH SAN FRANCISCO, Calif., Nov. 13, 2023 (GLOBE NEWSWIRE) -- Akero Therapeutics, Inc. (Nasdaq: AKRO), a clinical-stage company developing transformational treatments for patients with serious metabolic diseases marked by high unmet medical need, today reported third quarter financial results for the period ending September 30, 2023 and provided business updates.
  • Key secondary endpoints will include changes in biomarkers of liver fibrosis as well as measures of glycemic control and lipids.
  • Akero's cash, cash equivalents and short-term and long-term marketable securities for the period ended September 30, 2023 were $613.0 million.
  • Total operating expenses were $46.6 million for the three-month period ended September 30, 2023, compared to $36.1 million for the comparable period in 2022.

The Paul G. Allen Family Foundation awards $10.5 million to new Allen Distinguished Investigators

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火曜日, 11月 21, 2023

18 researchers will develop technologies, design approaches and uncover insights into fundamental areas of human biology

Key Points: 
  • 18 researchers will develop technologies, design approaches and uncover insights into fundamental areas of human biology
    The Paul G. Allen Family Foundation will award $1.5 million to seven research projects which 18 researchers will lead.
  • "Our two newest cohorts of Allen Distinguished Investigators are using innovative technologies and unprecedented ambition to pioneer new frontiers in the fields of sex hormones and extracellular vesicles.
  • said Kathy Richmond , Ph.D., M.B.A., Executive Vice President and Director of the Frontiers Group and the Office of Science and Innovation at the Allen Institute.
  • Including the new awards, a total of 130 Allen Distinguished Investigators have been appointed during the past 12 years.

Akero Therapeutics Reports Encouraging 36-Week Analysis of 96-Week Phase 2b SYMMETRY Study, with a Trend on Fibrosis Improvement and Statistically Significant Results for NASH Resolution, Markers of Liver Injury and Fibrosis, Insulin Sensitization and Lip

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火曜日, 10月 10, 2023

SOUTH SAN FRANCISCO, Oct. 10, 2023 (GLOBE NEWSWIRE) -- Akero Therapeutics, Inc. (Nasdaq: AKRO), a clinical-stage company developing transformational treatments for patients with serious metabolic disease marked by high unmet medical need, today reported a 36-week analysis of SYMMETRY, a 96-week Phase 2b study evaluating the efficacy and safety of its lead product candidate efruxifermin (EFX) in patients with compensated cirrhosis (F4) due to nonalcoholic steatohepatitis (NASH).

Key Points: 
  • In addition, 4% of patients in each of the EFX-treated groups experienced a three- or two-stage fibrosis improvement without worsening of NASH – from compensated cirrhosis (F4) to F1 or F2, compared with 0% for placebo.
  • Statistically significant improvements were also observed for both EFX groups in non-invasive markers of liver injury and fibrosis, insulin sensitization and lipoproteins.
  • I’m encouraged that statistically significant improvements on multiple measures of NASH pathogenesis were observed in EFX-treated patients.
  • This underlines the high unmet medical need to at least arrest progression or preferably reverse cirrhosis due to NASH.

Akero Therapeutics Announces Publication of the Harmony Phase 2b Trial Results in The Lancet Gastroenterology & Hepatology

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水曜日, 10月 4, 2023

SOUTH SAN FRANCISCO, Calif., Oct. 04, 2023 (GLOBE NEWSWIRE) -- Akero Therapeutics, Inc. (Nasdaq: AKRO), a clinical-stage company developing transformational treatments for patients with serious metabolic disease marked by high unmet medical need, today announced publication in The Lancet Gastroenterology & Hepatology of results from the HARMONY Phase 2b trial in nonalcoholic steatohepatitis (NASH).

Key Points: 
  • Results showed that both EFX doses achieved statistical significance on primary and secondary histopathology endpoints after 24 weeks.
  • Treatment with EFX was generally well-tolerated, with a tolerability profile comparable to that observed in Akero’s Phase 2a BALANCED study.
  • “Publication of the HARMONY Phase 2b trial results is an important milestone in our ongoing evaluation of EFX,” said Kitty Yale, chief development officer of Akero.
  • SYNCHRONY Real-World will assess safety and tolerability of EFX in patients with non-invasively diagnosed NASH or NAFLD.

How can I lower my cholesterol? Do supplements work? How about psyllium or probiotics?

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土曜日, 9月 16, 2023

You’ve six months to work on your diet to see if that’ll bring down your levels, then you’ll review your options.

Key Points: 
  • You’ve six months to work on your diet to see if that’ll bring down your levels, then you’ll review your options.
  • But there’s some good evidence that taking particular supplements, while also eating a healthy diet, can make a difference.

Why are we so worried about cholesterol?

    • Low-density lipoprotein or LDL cholesterol This is often called “bad” cholesterol.
    • This lipoprotein helps remove excess cholesterol from the bloodstream and transports it back to the liver for processing and excretion.
    • Diet can play a key role in reducing blood cholesterol levels, especially LDL (“bad”) cholesterol.

Fibre is your friend

    • An additional way to significantly reduce your total cholesterol and LDL cholesterol levels through diet is by eating more soluble fibre.
    • This is a type of fibre that dissolves in water to form a gel-like substance in your gut.

Fibre supplements, such as psyllium


    There are also many fibre supplements and food-based products on the market that may help lower cholesterol. These include:
    • Psyllium is the fibre supplement with the strongest evidence to support its use in improving cholesterol levels.
    • These trials show consuming about 10g of psyllium a day (1 tablespoon), as part of a healthy diet, can significantly lower total cholesterol levels by 4% and LDL cholesterol levels by 7%.

Probiotics

    • Probiotics are thought to help lower cholesterol levels via a number of mechanisms.
    • Using probiotics to reduce cholesterol is an upcoming area of interest and the research is promising.
    • Most of these studies use probiotics containing Lactobacillus acidophilus and Bifidobacterium lactis, which come in capsules or powders and are consumed daily.

Red yeast rice

    • Red yeast rice is another non-fibre supplement that has gained attention for lowering cholesterol.
    • It found taking red yeast rice supplements (200-4,800mg a day) was more effective for lowering blood fats known as triglycerides but less effective at lowering total cholesterol compared with statins.
    • However, these trials don’t tell us if red yeast rice works and is safe in the long term.

Diet and supplements may not be enough

    • Always speak to your GP and dietitian about your plan to take supplements to lower your cholesterol.
    • But remember, dietary changes alone – with or without supplements – might not be enough to lower your cholesterol levels sufficiently.
    • Even then, depending on your cholesterol levels and other risk factors, you may still be recommended cholesterol-lowering medications, such as statins.

Madrigal Pharmaceuticals Completes Submission of New Drug Application Seeking Accelerated Approval of Resmetirom for the Treatment of NASH with Liver Fibrosis

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月曜日, 7月 17, 2023

Resmetirom is a once daily, oral, thyroid hormone receptor (THR)-β selective agonist designed to target key underlying causes of NASH in the liver.

Key Points: 
  • Resmetirom is a once daily, oral, thyroid hormone receptor (THR)-β selective agonist designed to target key underlying causes of NASH in the liver.
  • In the pivotal Phase 3 MAESTRO-NASH serial liver biopsy trial, resmetirom achieved both liver histological improvement endpoints – resolution of NASH and reduction of liver fibrosis – proposed by FDA as reasonably likely to predict clinical benefit to support accelerated approval for the treatment of NASH with liver fibrosis.
  • In April 2023, resmetirom was granted Breakthrough Therapy designation by FDA for the treatment of adults with NASH with liver fibrosis.
  • We’d like to thank the many patients and investigators who have contributed to the clinical research supporting the resmetirom NDA.”