A randomized, double-blind Phase I clinical study to evaluate the safety, tolerability, pharmacokinetics, and immunogenicity of recombinant human FGF21-Fc fusion protein for injection (AP025) 50mg once weekly for 12 weeks in Chinese adult subjects with dyslipidemia

Start Date10 Oct 2023

Sponsor / Collaborator-

NCT06569524 / RecruitingPhase 2

A Double-blind, Placebo Randomized，Phase II Study to Evaluate the Efficacy and Safety of TQA2225/AP025 in Adults With Nonalcoholic Steatohepatitis (NASH)

A randomized, double-blind, placebo-controlled Phase II study，to evaluate the efficacy and safety of TQA2225/AP025 in Patients With Non-Alcoholic Steatohepatitis (NASH)

Start Date14 Sep 2023

Sponsor / Collaborator

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

CTR20232434 / Active, not recruitingPhase 1

评估注射用重组人FGF21-Fc融合蛋白（AP025）50mg 每周一次在中国成人血脂异常受试者中连续给药12周的安全性、耐受性、药代动力学特征及免疫原性特征的随机、双盲I期临床研究

[Translation] A randomized, double-blind, phase I clinical study to evaluate the safety, tolerability, pharmacokinetic characteristics and immunogenicity of recombinant human FGF21-Fc fusion protein for injection (AP025) 50 mg once a week for 12 consecutive weeks in Chinese adult subjects with dyslipidemia

主要目的：评估AP025 50mg QW在血脂异常受试者中多次给药后的安全性、耐受性。次要目的：评估AP025 50mg QW在血脂异常受试者中多次给药后的药代动力学特性。评估AP025 50mg QW在血脂异常受试者中多次给药后的免疫原性特征。评估AP025 50mg QW在血脂异常受试者中多次给药后的药效学特征。

[Translation]

Primary objective: To evaluate the safety and tolerability of AP025 50mg QW after multiple dosing in subjects with dyslipidemia. Secondary objectives: To evaluate the pharmacokinetic properties of AP025 50mg QW after multiple dosing in subjects with dyslipidemia. To evaluate the immunogenicity characteristics of AP025 50mg QW after multiple dosing in subjects with dyslipidemia. To evaluate the pharmacodynamic characteristics of AP025 50mg QW after multiple dosing in subjects with dyslipidemia.

Start Date05 Sep 2023

Sponsor / Collaborator

Anyuan Pharmaceutical Technology (Shanghai) Co., Ltd.

100 Clinical Results associated with Recombinat FGF21-Fc fusion Protein(Ampsource Biopharma)

100 Translational Medicine associated with Recombinat FGF21-Fc fusion Protein(Ampsource Biopharma)

100 Patents (Medical) associated with Recombinat FGF21-Fc fusion Protein(Ampsource Biopharma)

Literatures (Medical) associated with Recombinat FGF21-Fc fusion Protein(Ampsource Biopharma)

01 Aug 2023·Journal of Pharmaceutical and Biomedical Analysis

Noncompetitive immunoassay optimized for pharmacokinetic assessments of biologically active efruxifermin

Article

Author: Tillman, Erik J. ; Abdeen, Sanofar J. ; Kinne, Adam S. ; Rinker, Sherri ; Hurst, Jacob P. ; Parmer, Elijah S. ; Rolph, Timothy P. ; de Temple, Brittany ; Bowsher, Ronald R. ; Johnson, Derrick E.

Efruxifermin (EFX) is a homodimeric human IgG1 Fc-FGF21 fusion protein undergoing investigation for treatment of liver fibrosis due to nonalcoholic steatohepatitis (NASH), a prevalent and serious metabolic disease for which there is no approved treatment.Biol. activity of FGF21 requires its intact C-terminus, which enables binding to its obligate co-receptor β-Klotho on the surface of target cells.This interaction is a prerequisite for FGF21 signal transduction through its canonical FGF receptors: FGFR1c, 2c, and 3c.Therefore, the C-terminus of each FGF21 polypeptide chain must be intact, with no proteolytic truncation, for EFX to exert its pharmacol. activity in patients.A sensitive immunoassay for quantification of biol. active EFX in human serum was therefore needed to support pharmacokinetic assessments in patients with NASH.We present a validated noncompetitive electrochemiluminescent immunoassay (ECLIA) that employs a rat monoclonal antibody for specific capture of EFX via its intact C-terminus.Bound EFX is detected by a SULFO-TAG-conjugated, affinity purified chicken anti-EFX antiserum.The ECLIA reported herein for quantification of EFX demonstrated suitable anal. performance, with a sensitivity (LLOQ) of 20.0 ng/mL, to support reliable pharmacokinetic assessments of EFX.The validated assay was used to quantify serum EFX concentrations in a phase 2a study of NASH patients (BALANCED) with either moderate-to-advanced fibrosis or compensated cirrhosis.The pharmacokinetic profile of EFX was dose-proportional and did not differ between patients with moderate-to-advanced fibrosis and those with compensated cirrhosis.This report presents the first example of a validated pharmacokinetic assay specific for a biol. active Fc-FGF21 fusion protein, as well as the first demonstration of use of a chicken antibody conjugate as a detection reagent specific for an FGF21 analog.

01 Dec 2022·BMC Microbiology

Antibacterial efficacy of lytic phages against multidrug-resistant Pseudomonas aeruginosa infections in bacteraemia mice models

Article

Author: Sadagopan, Sathish ; Loh, Belinda ; Arumugam, Shri Natrajan ; Leptihn, Sebastian ; Manohar, Prasanth ; Nachimuthu, Ramesh ; Sukumaran, Sunilkumar

AbstractBackgroundPseudomonas aeruginosa is an opportunistic pathogen that can cause a variety of infections in humans, such as burn wound infections and infections of the lungs, the bloodstream and surgical site infections. Nosocomial spread is often concurrent with high degrees of antibiotic resistance. Such resistant strains are difficult to treat, and in some cases, even reserved antibiotics are ineffective. A particularly promising therapy to combat infections of resistant bacteria is the deployment of bacteriophages, known as phage therapy. In this work, we evaluated the in vivo efficacy of two Pseudomonas phages in bacteremia mice models. For this study, non-neutropenic mice (BalB/C) were infected with P. aeruginosa AB030 strain and treated using two bacteriophages, AP025 and AP006.ResultsThe results showed that a single dose of phages at higher concentrations, bacteria: phage at 1:10 and 1:100 were effective in eliminating the bloodstream infection and achieving 100% mice survival.ConclusionThis study highlights the efficacy of using a single dose of phages to restore mice from bacteremia.

01 Jul 2021·Nature MedicineQ1 · MEDICINE

Efruxifermin in non-alcoholic steatohepatitis: a randomized, double-blind, placebo-controlled, phase 2a trial

Q1 · MEDICINE

Article

Author: Hu, Chen ; Ruane, Peter J ; Neff, Guy ; Patil, Rashmee ; Fong, Erica ; Freilich, Bradley L ; Harrison, Stephen A ; de Temple, Brittany ; Rolph, Timothy P ; Cheng, Andrew ; Behling, Cynthia A ; Yale, Kitty ; Tillman, Erik J

Preclinical and clinical data suggest that fibroblast growth factor 21 (FGF21) is anti-fibrotic, improves metabolic status and has potential to treat non-alcoholic steatohepatitis (NASH). We assessed the safety and efficacy of efruxifermin, a long-acting Fc-FGF21 fusion protein, for the treatment of NASH. BALANCED was a randomized, placebo-controlled study in patients with NASH conducted at 27 centers in the United States (ClinicalTrials.gov NCT03976401 ). Eighty patients, stratified by hepatic fat fraction (HFF) and fibrosis stage, were randomized using a centrally administered minimization algorithm 1:1:1:1 to receive placebo (n = 21) or efruxifermin 28 mg (n = 19), efruxifermin 50 mg (n = 20) or efruxifermin 70 mg (n = 20) via weekly subcutaneous injection for 16 weeks. The primary endpoint-absolute change from baseline in HFF measured as magnetic resonance imaging-proton density fat fraction at week 12-was met. For the full analysis set, the least squares mean absolute changes (one-sided 97.5% confidence interval) from baseline in HFF were -12.3% (-infinity (-inf), -10.3), -13.4% (-inf, -11.4) and -14.1% (-inf, -12.1) in the 28-, 50- and 70-mg groups, respectively, versus 0.3% (-inf, 1.6) in the placebo group, with statistically significant differences between efruxifermin groups and placebo (P < 0.0001 each). Overall, 70 of 79 patients who received the study drug (89%) experienced at least one treatment-emergent adverse event (TEAE), with the majority grade 1-2 (64 (81%)), five (6%) grade 3 and one grade 4. The most commonly reported drug-related TEAEs were grade 1-2 gastrointestinal (36 (46%)). Treatment with efruxifermin significantly reduced HFF in patients with F1-F3 stage NASH, with an acceptable safety profile.

News (Medical) associated with Recombinat FGF21-Fc fusion Protein(Ampsource Biopharma)

21 Jun 2022

·www.globenewswire.com

89bio to Present Additional Pegozafermin Data at EASL International Liver Congress™ 2022

SAN FRANCISCO, June 21, 2022 (GLOBE NEWSWIRE) -- 89bio, Inc. (Nasdaq: ETNB), a clinical-stage biopharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of liver and cardio-metabolic diseases, today announced additional pegozafermin data in non-alcoholic steatohepatitis (NASH) will be presented at the European Association for the Study of the Liver (EASL) International Liver Congress™ 2022, to be held in London, UK on June 22-26, 2022. Presentation details are as follows: Abstract Title: Pegozafermin Led to Improved Liver Histology, Liver-related Non-invasive Tests and Metabolic Profile, With Favorable Safety and Tolerability, in an Open-label Cohort of a Phase 1b/2a Study in Subjects With Non-alcoholic SteatohepatitisAbstract Number: 3535Format: Poster presentation (#SAT-139)Presenting Author: Rohit Loomba, MD, MHSc, Director, NAFLD Research Center, University of California San DiegoPresentation Date and Time: Saturday, June 25th 9:00 – 18:30 BST Abstract Title: Pegozafermin Led to Significant Metabolic Benefits, in Addition to Robust Beneficial Effects on the Liver, in an Open-label Cohort of a Phase 1b/2a Study in Subjects with Non-alcoholic Steatohepatitis (NASH)Abstract Number: 3654Format: Poster presentation (#SAT-143) Presenting Author: Naim Alkhouri, MD, Chief of Transplant Hepatology and Director of the Fatty Liver Program, Arizona Liver Health (ALH)Presentation Date and Time: Saturday, June 25th 9:00 – 18:30 BST Abstract Title: Pharmacokinetics (PK) and Pharmacodynamics (PD) of BIO89-100, a Novel GlycoPEGylated FGF21, in Nonalcoholic Steatohepatitis (NASH) Patients with Compensated CirrhosisAbstract Number: 1520Format: Poster presentation (#SAT-131)Presenting Author: Naim Alkhouri, MD, Chief of Transplant Hepatology and Director of the Fatty Liver Program, Arizona Liver Health (ALH)Presentation Date and Time: Saturday, June 25th 9:00 – 18:30 BST 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 candidate, pegozafermin, through clinical development for the treatment of non-alcoholic steatohepatitis (NASH) and severe hypertriglyceridemia (SHTG). Pegozafermin is a specifically engineered, potentially best-in-class fibroblast growth factor 21 (FGF21) analog with unique glycoPEGylated technology that optimizes biological activity through an extended half-life. The company is headquartered in San Francisco with operations in Herzliya, Israel. For more information, visit www.89bio.com or follow the company on LinkedIn. Investor Contact: Ryan Martins Chief Financial Officer investors@89bio.com

100 Deals associated with Recombinat FGF21-Fc fusion Protein(Ampsource Biopharma)

R&D Status

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Nonalcoholic Steatohepatitis	Phase 2	CN	Anyuan Pharmaceutical Technology (Shanghai) Co., Ltd.	22 Aug 2023
Dyslipidemias	Phase 1	CN	Anyuan Pharmaceutical Technology (Shanghai) Co., Ltd.	05 Sep 2023
Hypertriglyceridemia	IND Approval	CN	Anyuan Pharmaceutical Technology (Shanghai) Co., Ltd.	30 Nov 2023

Clinical Result

Indication

Phase

Evaluation

View All Results

Translational Medicine

Boost your research with our translational medicine data.

view full example data

Deal

Boost your decision using our deal data.

view full example data

Core Patent

Boost your research with our Core Patent data.

view full example data

Clinical Trial

Identify the latest clinical trials across global registries.

view full example data

Approval

Accelerate your research with the latest regulatory approval information.

view full example data

Regulation

Understand key drug designations in just a few clicks with Synapse.

view full example data

Chat with Hiro

Get started for free today!

Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.

Start your data trial now!

Synapse data is also accessible to external entities via APIs or data packages. Empower better decisions with the latest in pharmaceutical intelligence.

Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis

Recombinat FGF21-Fc fusion Protein(Ampsource Biopharma)

Overview

Basic Info

Related

R&D Status

Clinical Result

Translational Medicine

Deal

Core Patent

Clinical Trial

Approval

Regulation