Delving into the Latest Updates on Peginterferon alpha-2b biosimilar(Zydus Cadila Healthcare Ltd.) with Synapse

Overview

Basic Info

Drug Type

Interferons, Biosimilar

Synonyms

Peg IFN α-2b, PegiHep, Peginterferon alpha 2b biosimilar

+ [2]

Target

IFNAR

Action

agonists, stimulants, inducers

Mechanism

IFNAR agonists(Interferon alpha/beta receptor agonists), Immunostimulants, Innate antiviral immune response inducers

Therapeutic Areas

Infectious DiseasesDigestive System DisordersSkin and Musculoskeletal Diseases+ [1]

Active Indication

Condylomata AcuminataHepatitis BHepatitis C

Inactive Indication

COVID-19

Originator Organization

Zydus Cadila Healthcare Ltd.

Active Organization

Zydus Cadila Healthcare Ltd.

Inactive Organization

Zydus Lifesciences Ltd.

Drug Highest PhaseApproved

First Approval Date

Japan (01 Jan 2014),

Condylomata AcuminataHepatitis BHepatitis C

Regulation-

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Structure/Sequence

Sequence Code 26333714

The sequence is quoted from: *****

Background:Peginterferon (PegIFN) has shown promising results in the treatment of chronic hepatitis B (CHB). This study aimed to evaluate the effects of PegIFN α-2b on growth and thyroid function in young children with CHB.Methods:A retrospective study was performed by extracting clinical data from children with CHB who received PegIFN α-2b monotherapy at the Public Health Clinical Center of Chengdu between June 2017 and December 2020. Mean, SD, independent samples t test and 1-way repeated analysis of variance were used to evaluate relevant data.Results:A total of 62 children were included in this study. Overall, significant differences were observed in the weight-for-age z score (WAZ), height-for-age z score (HAZ) and body mass index-for-age z score (BAZ) at different time points (P < 0.001). WAZ, HAZ and BAZ were not affected by PegIFN α-2b at 24 weeks of treatment (all P > 0.05). WAZ, HAZ and BAZ at the end of treatment and 48 weeks after treatment; WAZ at 96 weeks after treatment were lower than baseline levels (all P < 0.05). No statistical differences were found in HAZ and BAZ at 96 weeks after treatment compared with baseline. Thyroid dysfunction developed in 17.7% of children during the treatment. Thyroid dysfunction was transient and had no effect on growth.Conclusions:PegIFN α-2b has inhibitory effects on growth and can increase the incidence of thyroid dysfunction in young children with CHB. These effects are generally reversible with the cessation of therapy, although WAZ had not returned to baseline after 96 weeks of observation.

01 Jul 2024·Antiviral Research

Quantitative HBeAg is a strong predictor of HBeAg loss among patients receiving pegylated interferon

Article

Author: Chang, Jason ; Ahmed, Taufique ; Tay, Amy ; Shen, Liang ; Anderson, Mark ; Butler, Emily K ; Huang, Daniel Q ; Ngu, Jing Hieng ; Khine, Htet Toe Wai ; Lee, Chris ; Holzmayer, Vera ; Kuhns, Mary C ; Tan, Jessica ; Gersch, Jeffrey ; Tan, Poh Seng ; Cloherty, Gavin ; Lee, Guan Huei ; McNamara, Anne L ; Lee, Yin Mei ; Muthiah, Mark ; Dan, Yock Young ; Lim, Seng Gee ; Phyo, Wah Wah ; Yang, Wei Lyn

BACKGROUNDHBeAg loss is an important endpoint for antiviral therapy in chronic hepatitis B (CHB), however there are no reliable biomarkers to identify patients who will respond to the addition of pegylated interferon to nucleos(t)ide analogue (NA) therapy.AIMTo evaluate the use of serum biomarkers to predict HBeAg loss.METHODSHBeAg positive CHB participants on NAs who switched-to or added-on 48 weeks pegylated interferon alpha2b (clinicaltrial.gov NCT01928511) were evaluated at week 72 for HBeAg loss. The predictive ability of qHBeAg, qHBsAg, HBV RNA and clinical variables for HBeAg loss were investigated.RESULTSHBeAg loss occurred in 15/55 (27.3%) participants who completed 48 weeks of pegylated interferon. There was a lower baseline qHBeAg (1.18 IU/mL [2.27] versus 10.04 IU/mL [24.87], P = 0.007) among participants who lost HBeAg. Baseline qHBeAg (OR = 0.15, 95% CI 0.03-0.66, P = 0.01) and detectable HBV DNA at baseline (OR = 25.00, 95% CI 1.67-374.70, P = 0.02) were independent predictors of HBeAg loss. In addition, on-treatment qHBeAg was also a strong predictor of HBeAg loss (OR = 0.39, 95% CI 0.18-0.81, P = 0.012). The models combining detectable baseline HBV DNA with baseline (C-statistic 0.82) and on-treatment (C-statistic 0.83) had good accuracy for predicting HBeAg loss. A rise in qHBeAg ≥ 10 IU/ml was a predictor of flare (ALT ≥ 120 U/ml) on univariable analysis but not after adjustment for treatment arm.CONCLUSIONSBaseline and on-treatment qHBeAg is a useful biomarker that can identify participants on NA therapy who may benefit from adding or switching to pegylated interferon.

01 Jun 2024·Polish Journal of Microbiology

Guanylate-Binding Protein 1 (GBP1) Enhances IFN-α Mediated Antiviral Activity against Hepatitis B Virus Infection

Article

Author: Tan, Guili ; Luo, Huating ; Qin, Bo ; Luo, Haiying ; Wang, Rui ; Yu, Renjie ; Gong, Jiaojiao ; Hu, Xiaoxia ; Li, Yadi ; Pang, Hao

AbstractInterferon-alpha (IFN-α) is a first-line drug for treating chronic hepatitis B (CHB). Guanylate-binding protein 1 (GBP1) is one of the interferon-stimulating factors, which participates in the innate immunity of the host and plays an antiviral and antibacterial role. In this study, we explored how GBP1 is involved in IFN-α antiviral activity against HBV. Before being gathered, HepG2-NTCP and HepG2 2.15 cells were transfected with the wild-type hGBP1 plasmid or si-GBP1, respectively, and followed by stimulation with Peg-IFNα-2b. We systematically explored the role of GBP1 in regulating HBV infection in cell models. Additionally, we also examined GBP1 levels in CHB patients. GBP1 activity increased, and its half-life was prolonged after HBV infection. Overexpression of GBP1 inhibited the production of HBsAg and HBeAg, as well as HBs protein and HBV total RNA levels, whereas silencing of GBP1 inhibited its ability to block viral infections. Interestingly, overexpressing GBP1 co-treatment with Peg-IFNα-2b further increased the antiviral effect of IFN-α, while GBP1 silencing co-treatment with Peg-IFNα-2b partly restored its inhibitory effect on HBV. Mechanistically, GBP1 mediates the anti-HBV response of Peg-IFNα-2b by targeting HBs. Analysis of clinical samples revealed that GBP1 was elevated in CHB patients and increased with Peg-IFNα-2b treatment, while GBP1 showed good stability in the interferon response group. Our study demonstrates that GBP1 inhibits HBV replication and promotes HBsAg clearance. It is possible to achieve antiviral effects through the regulation of IFN-α induced immune responses in response to HBV.

100 Deals associated with Peginterferon alpha-2b biosimilar(Zydus Cadila Healthcare Ltd.)

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External Link

KEGG	Wiki	ATC	Drug Bank
-	-	L03AB10	-

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Condylomata Acuminata	Japan	Zydus Cadila Healthcare Ltd.	01 Jan 2014
Hepatitis B	Japan	Zydus Cadila Healthcare Ltd.	01 Jan 2014
Hepatitis C	Japan	Zydus Cadila Healthcare Ltd.	01 Jan 2014

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
COVID-19	Phase 2	Mexico	Zydus Lifesciences Ltd.	11 Aug 2020

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


EHA2024	Not Applicable	Polycythemia Vera \| Thrombocythemia, Essential	81	Peg-IFN-α-2b	(pjopwydusy) = rkwutclxbv ovusisxqfh (etodfulosw )	Positive	14 May 2024
ASCO_GI2018	Not Applicable	Unresectable Intrahepatic Cholangiocarcinoma	21	Hepatic arterial infusion chemotherapy (HAIC) using 5-fluorouracil and subcutaneous PEG-IFN α-2b	(cyywdpjhaf) = All adverse reactions were controllable by temporary suspension of treatment. Serious complications and treatment related deaths were not observed. drvqejpefa (anhagnvpbq )	Positive	26 Feb 2018
ASCO_GI2015	Not Applicable	Advanced Hepatocellular Carcinoma	59	Combined hepatic arterial infusion chemotherapy of 5-fluorouracil (5-FU) and systemic pegylated interferon (PEG-IFN) α-2b	xtdgihdmco(kguvwazrbb) = hgxxznnxgy xhqdqjerze (iaovawlnki ) View more	-	20 Jan 2015
IAS2007	Not Applicable	HIV Infections \| Hepatitis C	-	Standard weekly PEG-IFN	(wjgpbozotm) = The adverse events were similar in both arms sfxidqnate (wdfpfoqtcr )	Positive	01 Jan 2007
IAS2007	Not Applicable	HIV Infections \| Hepatitis C	-	Twice weekly Peg-IFN		Positive	01 Jan 2007

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Biosimilar

Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.

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