First FGF21 analog to enter Phase 3 development
SAN FRANCISCO, CA, USA I May 23, 2023 I 89bio, Inc. (Nasdaq: ETNB), a clinical-stage biopharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of liver and cardiometabolic diseases, today announced the initiation of ENTRUST, a Phase 3 trial evaluating the efficacy, safety and tolerability of pegozafermin in patients with severe hypertriglyceridemia (SHTG).
“We are pleased to initiate the ENTRUST trial of pegozafermin in SHTG, an important milestone for the company that demonstrates the rapid progress we have made since inception, and also signifies entry of the first FGF21 analog into Phase 3 development,” said Hank Mansbach, Chief Medical Officer of 89bio. “We believe results from our previous trials in SHTG suggest a potentially favorable risk/benefit profile for pegozafermin as demonstrated through robust reductions in triglycerides, broad metabolic improvements including reductions in liver fat, as well as favorable safety and tolerability. We remain encouraged by pegozafermin’s unique and differentiated profile relative to existing therapies and those in development to treat SHTG. Additionally, we believe there are opportunities for development synergies within our pegozafermin program and plan to leverage the safety database from the SHTG Phase 3 program to optimize clinical advancement in non-alcoholic steatohepatitis (NASH).”
ENTRUST is a randomized, double-blind, placebo-controlled global trial that is planned to enroll up to 360 SHTG patients randomized in a 3:3:2 ratio of pegozafermin (30 mg, 20 mg or placebo) given once weekly (QW) by subcutaneous injection for 52 weeks. The primary endpoint is the percent change from baseline in fasting triglycerides at Week 26 compared to placebo. Secondary endpoints include the assessment of liver fat measured by magnetic resonance imaging proton density fat fraction (MRI-PDFF), non-high-density lipoprotein cholesterol (non-HDL-C), high-density lipoprotein cholesterol (HDL-C), apolipoprotein B (apo-B), very low-density lipoprotein cholesterol (VLDL-C), HbA1c for those with baseline ≥ 6.5%, and total cholesterol (TC) at Week 26 compared to placebo. More information about the trial is available at ClinicalTrials.gov (NCT05852431).
About severe hypertriglyceridemia (SHTG)
SHTG is a lipid abnormality characterized by severely elevated triglyceride (TG) levels (> 500mg/dL) and associated with an increased risk for acute pancreatitis and atherosclerotic cardiovascular diseases. It is an underappreciated condition that affects up to four million people in the United States with an urgent need for treatments that can effectively reduce TG levels and improve comorbidities. Patients with SHTG have multiple co-morbid metabolic disorders such as dyslipidemia (up to 65%), Type 2 diabetes mellitus (up to 70%) and non-alcoholic fatty liver disease (NAFLD; up to 100%). The current standard of care for SHTG includes lifestyle changes and medications that include fish oils, fibrates, niacin and statins. However, studies have shown that these therapies only have a modest effect on triglycerides and do not provide broader metabolic benefits and it is estimated that ~50% of treated patients (~900,000 in the United States) are unable to bring their triglyceride levels below 500 mg/dL.
About pegozafermin
Pegozafermin is a specifically engineered glycoPEGylated analog of fibroblast growth factor 21 (FGF21) being developed for the treatment of non-alcoholic steatohepatitis (NASH) and severe hypertriglyceridemia (SHTG). FGF21 is a promising therapeutic target for NASH and SHTG since it is an endogenous hormone that functions as a master metabolic regulator with broad effects on energy expenditure and glucose and lipid metabolism. Enhancing the activity of FGF21 has been shown to reduce hepatic steatosis, inflammation, and triglyceride levels, as well as improve insulin resistance and glycemic control.
About 89bio
89bio is a clinical-stage biopharmaceutical company dedicated to the development of best-in-class therapies for patients with liver and cardiometabolic diseases who lack optimal treatment options. The company is focused on rapidly advancing its lead therapeutic candidate, pegozafermin, through clinical development for the treatment of non-alcoholic steatohepatitis (NASH) and severe hypertriglyceridemia (SHTG). The company is headquartered in San Francisco. For more information, visit www.89bio.com or follow the company on LinkedIn.
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First FGF21 analog to enter Phase 3 development
SAN FRANCISCO, CA, USA I May 23, 2023 I 89bio, Inc. (Nasdaq: ETNB), a clinical-stage biopharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of liver and cardiometabolic diseases, today announced the initiation of ENTRUST, a Phase 3 trial evaluating the efficacy, safety and tolerability of pegozafermin in patients with severe hypertriglyceridemia (SHTG).
“We are pleased to initiate the ENTRUST trial of pegozafermin in SHTG, an important milestone for the company that demonstrates the rapid progress we have made since inception, and also signifies entry of the first FGF21 analog into Phase 3 development,” said Hank Mansbach, Chief Medical Officer of 89bio. “We believe results from our previous trials in SHTG suggest a potentially favorable risk/benefit profile for pegozafermin as demonstrated through robust reductions in triglycerides, broad metabolic improvements including reductions in liver fat, as well as favorable safety and tolerability. We remain encouraged by pegozafermin’s unique and differentiated profile relative to existing therapies and those in development to treat SHTG. Additionally, we believe there are opportunities for development synergies within our pegozafermin program and plan to leverage the safety database from the SHTG Phase 3 program to optimize clinical advancement in non-alcoholic steatohepatitis (NASH).”
ENTRUST is a randomized, double-blind, placebo-controlled global trial that is planned to enroll up to 360 SHTG patients randomized in a 3:3:2 ratio of pegozafermin (30 mg, 20 mg or placebo) given once weekly (QW) by subcutaneous injection for 52 weeks. The primary endpoint is the percent change from baseline in fasting triglycerides at Week 26 compared to placebo. Secondary endpoints include the assessment of liver fat measured by magnetic resonance imaging proton density fat fraction (MRI-PDFF), non-high-density lipoprotein cholesterol (non-HDL-C), high-density lipoprotein cholesterol (HDL-C), apolipoprotein B (apo-B), very low-density lipoprotein cholesterol (VLDL-C), HbA1c for those with baseline ≥ 6.5%, and total cholesterol (TC) at Week 26 compared to placebo. More information about the trial is available at ClinicalTrials.gov (NCT05852431).
About severe hypertriglyceridemia (SHTG)
SHTG is a lipid abnormality characterized by severely elevated triglyceride (TG) levels (> 500mg/dL) and associated with an increased risk for acute pancreatitis and atherosclerotic cardiovascular diseases. It is an underappreciated condition that affects up to four million people in the United States with an urgent need for treatments that can effectively reduce TG levels and improve comorbidities. Patients with SHTG have multiple co-morbid metabolic disorders such as dyslipidemia (up to 65%), Type 2 diabetes mellitus (up to 70%) and non-alcoholic fatty liver disease (NAFLD; up to 100%). The current standard of care for SHTG includes lifestyle changes and medications that include fish oils, fibrates, niacin and statins. However, studies have shown that these therapies only have a modest effect on triglycerides and do not provide broader metabolic benefits and it is estimated that ~50% of treated patients (~900,000 in the United States) are unable to bring their triglyceride levels below 500 mg/dL.
About pegozafermin
Pegozafermin is a specifically engineered glycoPEGylated analog of fibroblast growth factor 21 (FGF21) being developed for the treatment of non-alcoholic steatohepatitis (NASH) and severe hypertriglyceridemia (SHTG). FGF21 is a promising therapeutic target for NASH and SHTG since it is an endogenous hormone that functions as a master metabolic regulator with broad effects on energy expenditure and glucose and lipid metabolism. Enhancing the activity of FGF21 has been shown to reduce hepatic steatosis, inflammation, and triglyceride levels, as well as improve insulin resistance and glycemic control.
About 89bio
89bio is a clinical-stage biopharmaceutical company dedicated to the development of best-in-class therapies for patients with liver and cardiometabolic diseases who lack optimal treatment options. The company is focused on rapidly advancing its lead therapeutic candidate, pegozafermin, through clinical development for the treatment of non-alcoholic steatohepatitis (NASH) and severe hypertriglyceridemia (SHTG). The company is headquartered in San Francisco. For more information, visit www.89bio.com or follow the company on LinkedIn.
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