This is a prospective study to evaluate the safety and efficacy of Sintilimab (PD-1 antibody) in sequential combination with Peg-IFNα-2b in NA-supressed CHB patients who had previously received Peg-IFNα therapy.

Start Date15 Jun 2024

Sponsor / Collaborator

302 Military Hospital of China

ChiCTR2400080005 / SuspendedEarly Phase 1

A prospective study to evaluate the safety and efficacy of TACE combined with Peg IFNa-2b+NAs+PD-1 inhibitor in patients with HBV-related hepatocellular carcinoma after radical resection

Start Date11 Feb 2024

Sponsor / Collaborator

Xiamen Hospital of Traditional Chinese Medicine

ChiCTR2300074909 / RecruitingPhase 1IIT

Evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of nebulized inhalation of pegylated interferon alpha-2b injection in healthy adult subjects

Start Date13 Aug 2023

Sponsor / Collaborator-

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

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

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

966

Literatures (Medical) associated with Peginterferon alpha-2b biosimilar(Zydus Cadila Healthcare Ltd.)

01 Nov 2024·GRAEFES ARCHIVE FOR CLINICAL AND EXPERIMENTAL OPHTHALMOLOGY

Comparison of postoperative topical interferon-α2b versus intraoperative mitomycin C for pterygium recurrence prevention: a randomized clinical trial

Article

Author: Mahmoudi, Hadi ; Moghadam, Reza Soltani ; Leili, Ehsan Kazemnezhad ; Medghalchi, Abdolreza ; Akbari, Mitra

PURPOSE:

To evaluate the effect of postoperative interferon-alpha 2b (IFN-α2b) ophthalmic drops versus intraoperative mitomycin-c (MMC) on preventing pterygium recurrence.

METHODS:

This prospective randomized clinical trial was conducted on patients who were candidates for pterygium surgery. A total of 75 patients were included in the study from December 2021 to December 2022, of which 64 patients (one eye each) were examined and analyzed based on the inclusion criteria. Then the patients were randomly assigned to control groups, intra-operative MMC (32 patients) and the intervention group, IFN-α2b drops after the operation (32 patients). All patients underwent pterygium surgery using the rotational conjunctival flap method.

RESULTS:

In terms of pterygium grading, 8 (12.5%), 25 (39.06%), and 31 (48.44%) eyes were in grades 1, 2, and 3, respectively. The average size of the pterygium was 3.6 ± 0.7 mm. The grade and size of pterygium had the same distribution in the two groups. There was no statistically significant difference between the two groups in the level of post-operative clinical inflammation. The present study showed no significant difference in complications between the two groups (p = 0.999). The recurrence rate in the control group was 9.4% (3 eyes), and 0% (no recurrence) in the intervention group (p = 0.119).

CONCLUSIONS:

interferon-alpha 2b group did not show a statistically significant difference in preventing pterygium recurrence compared to the mitomycin C group. The post-surgery administration of IFN-α 2b drops can effectively prevent pterygium recurrence with a comparable and even more compelling effect than MMC during surgery.

01 Oct 2024·JOURNAL OF HEPATOLOGY

ALT to qHBsAg ratio predicts HBsAg seroclearance in HBeAg-negative hepatitis B patients with Peg-IFN-α-based therapy

Letter

Author: Wang, Jian ; Zhang, Shaoqiu ; Huang, Rui ; Zhang, Qun ; Wu, Chao

01 Sep 2024·Gastroenterologia y Hepatologia

Clinical and economic value of bulevirtide in the treatment of chronic hepatitis D

Article

Author: Buti, María ; Rodríguez, MÁ. ; Cantero, H. ; Espinoza-Cámac, Nataly ; Calleja, Jose Luis ; Domínguez-Hernández, R. ; Domínguez-Hernández, Raquel ; Casado, Miguel Ángel ; Casado, MÁ. ; Espinoza, N. ; Cantero, Helena ; Calleja, JL. ; Buti, M. ; Rodríguez, Miguel Ángel

BACKGROUND/AIMS:

Bulevirtide (Hepcludex®) is the first drug approved for the treatment of chronic hepatitis D (CHD), unlike the current off-label treatment (PEG-IFN-α), limited in clinical practice and associated with post-treatment relapses. In a hypothetical cohort of CHD patients in Spain, the study aim was to compare the efficiency of bulevirtide with PEG-IFN-α in terms of clinical events avoided and associated cost savings.

METHODS:

A validated economic model reflecting the natural history of the disease was used to project lifetime liver complications and costs for two hypothetical cohorts treated with bulevirtide or PEG-IFN-α. The model considered progression to complications such as decompensated cirrhosis (DCC), hepatocellular carcinoma (HCC), liver transplantation (LT), and death. The efficacy rates used at 24 and 48 weeks were defined as the combined response rate for bulevirtide and undetectable HDV RNA to PEG-IFN-α. The numbers of clinic events and associated costs were evaluated from the perspective of the National Healthcare System.

RESULTS:

In a hypothetical cohort of 3882 patients, bulevirtide reduced the numbers of complications events in comparison to PEG-IFN-α (152 DCC, 113 HCC, 11 LT, and 321 deaths over a lifetime). This was associated with a reduction of event-related costs of €11,837,044 (DCC €1,138,059; HCC €1,503,583; LT €7,834,291; and death €1,361,111).

CONCLUSION:

In patients with CHD, bulevirtide could prevent a significant number of clinical events compared to PEG-IFN-α and contribute to cost savings through these reduction in liver complications. Further testing for hepatitis D virus is needed so that more patients can benefit from bulevirtide.

News (Medical) associated with Peginterferon alpha-2b biosimilar(Zydus Cadila Healthcare Ltd.)

22 Jul 2024

·www.globenewswire.com

Aligos Therapeutics Announces Clinical Collaboration with Xiamen Amoytop Biotech Co., Ltd.

Amoytop to sponsor a Phase 1b exploratory clinical study evaluating the efficacy and safety of ALG-000184 in combination with PEGBING® (Mipeginterferon alfa-2b) in CHB patients SOUTH SAN FRANCISCO, Calif., July 22, 2024 (GLOBE NEWSWIRE) -- Aligos Therapeutics, Inc. (Nasdaq: ALGS, “Aligos”), a clinical stage biopharmaceutical company focused on developing novel therapeutics to address unmet medical needs in liver and viral diseases, today announced that it has entered into a clinical trial collaboration agreement with Xiamen Amoytop Biotech Co., Ltd. (“Amoytop”). Under the terms of the agreement, Amoytop will sponsor and perform a Phase 1b exploratory clinical study evaluating the efficacy and safety of ALG-000184 in combination with PEGBING® (Mipeginterferon alfa-2b) in chronic hepatitis B (CHB) patients in China. The clinical study is expected to begin after approval by the National Medical Products Administration in China. “We are pleased to build on our existing relationship with Amoytop, as they have proven to be a valuable partner,” stated Lawrence Blatt, Ph.D., MBA, Chairman, President, and Chief Executive Officer at Aligos Therapeutics. “We look forward to initiating this exploratory study to evaluate the combination of ALG-000184 with PEGBING®, one of the approved drugs for CHB patients in China, to assess the potential benefits of a combinatory approach.” ALG-000184 is a potent best/first-in-class oral small molecule capsid assembly modulator (CAM-E) being developed for CHB. It is designed to exploit the dual role of CAMs by disrupting hepatitis B cccDNA levels and its derived transcripts by reducing expression of viral markers such as DNA, RNA, and the relevant antigens (HBsAg, HBeAg, HBcrAg). Phase 1a studies have demonstrated after single and multiple daily doses that ALG-000184 was well-tolerated, with no safety signals observed, and demonstrated linear pharmacokinetics (PK) and excellent antiviral activity. In longer term Phase 1b studies of ALG-000184 300mg x ≤96 weeks ± entecavir (ETV), ALG-000184 monotherapy has demonstrated best-in-class reductions in HBV DNA, RNA, HBsAg, HBeAg, and HBcrAg without viral breakthrough to date. PEGBING®, independently developed by Amoytop, is the world's first 40kD pegylated interferon α-2b injection. With dual effects of inhibiting viral replication and enhancing immunity, PEGBING® is mainly used in the clinical treatment of viral hepatitis and is the first-line drug for the antiviral treatment of chronic hepatitis B, which plays an important role in improving the clinical cure rate of hepatitis B and reducing the risk of liver cancer. “We are pleased to deepen our cooperation in the field of liver disease treatment and look forward to working together to provide a new treatment solution for patients in need,” said Sun Li, Chairman and Chief Executive Officer at Amoytop. “Amoytop is committed to further optimizing the chronic hepatitis B combination treatment pathway and hopes that the cooperation will lead to better clinical value drugs and drug combinations.” The Phase 1b study will be a randomized, double blinded, active controlled study to evaluate the safety, pharmacokinetics, and antiviral activity of oral once daily doses of 300 mg ALG-000184 + PEGBING® + entecavir (ETV) compared with 300 mg ALG-000184 + ETV or PEGBING® + ETV in treatment naïve or currently-not-treated HBeAg-positive and nucleos(t)ide analog (NA) suppressed HBeAg-negative subjects with CHB for 48 weeks. About Aligos Aligos Therapeutics, Inc. is a clinical stage biopharmaceutical company that was founded in 2018 with the mission to become a world leader in the treatment of liver and viral diseases. Aligos’ strategy is to harness the deep expertise and decades of drug development experience its team has in liver and viral diseases to discover and develop potentially best-in-class therapeutics for metabolic dysfunction-associated steatohepatitis (MASH) and viruses with high unmet medical need such as hepatitis B and coronaviruses. For more information, please visit www.aligos.com or follow us on LinkedIn or X. About Xiamen Amoytop Biotech Co., Ltd. Xiamen Amoytop Biotech Co., Ltd. is an innovative biopharmaceutical company and a listed company on the Science and Technology Innovation Board (SSE STAR Market) in China, specializing in R&D, manufacturing and marketing of regular and long-acting recombinant protein drugs. Focusing on the R&D of immune-related cytokine medicines, Amoytop is committed to becoming a leader in solving cytokine medicine-based systemic immune problems, providing better solutions for major diseases (such as viral hepatitis, malignant tumors) and immunotherapy. Forward-Looking Statements This press release contains forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. Any statements in this press release that are not historical facts may be considered “forward-looking statements,” including, without limitation, statements regarding Aligos’ financial results and performance as well as research and development activities, including regulatory status and the timing of announcements and updates relating to our regulatory filings and clinical trials. Such forward-looking statements are subject to substantial risks and uncertainties that could cause our development programs, future results, performance, or achievements to differ materially from those anticipated in the forward-looking statements. Such risks and uncertainties include, without limitation, risks and uncertainties inherent in the drug development process, including Aligos’ clinical stage of development, the process of designing and conducting clinical trials, the regulatory approval processes, and other matters that could affect the sufficiency of Aligos’ capital resources to fund operations. For a further description of the risks and uncertainties that could cause actual results to differ from those anticipated in these forward-looking statements, as well as risks relating to the business of Aligos in general, see Aligos’ Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on May 7, 2024 and its future periodic reports to be filed or submitted with the Securities and Exchange Commission. Except as required by law, Aligos undertakes no obligation to update any forward-looking statements to reflect new information, events or circumstances, or to reflect the occurrence of unanticipated events. Aligos Therapeutics Investor Contact Jordyn TaraziVice President, Investor Relations & Corporate Communications+1 (650) 910-0427jtarazi@aligos.com Media Contact Michael FitzhughLifeSci Communicationsmfitzhugh@lifescicomms.com Xiamen Amoytop Biotech Co., Ltd. Investor Contact Liu Peiyu联系电话：86592-6889118邮箱：ir@amoytop.com Media Contact Wu Xueyan联系电话：86592-6889127邮箱：wxy@amoytop.com

Phase 1License out/inPhase 2

22 Jul 2024

·firstwordpharma.com

Aligos links up with Amoytop to test Hep B combo in China

After its initial chronic hepatitis B (CHB) candidate failed in the clinic a few years ago, Aligos Therapeutics is now moving forward with a different approach. The biotech on Monday partnered with Xiamen Amoytop Biotech to test its next CHB hopeful, ALG-000184, in combination with the latter’s Pegbing (mipeginterferon alfa-2b).ALG-000184 is an oral small molecule capsid assembly modulator designed to disrupt the virus’s covalently closed circular DNA (cccDNA) levels by suppressing viral marker expression. Amoytop’s pegylated interferon α-2b injection is approved in China as a first-line antiviral treatment for CHB. Amoytop will be in charge of running the Phase Ib study, which will enrol CHB treatment-naïve patients in China and is expected to start following clearance from the country’s regulator. Patients who are positive for HBeAg and currently are not receiving treatment, as well as nucleos(t)ide analog suppressed HBeAg-negative patients, are also eligible for the trial. The randomised, double-blind study will evaluate the safety and efficacy of an oral, once-daily 300-mg dose of ALG-000184 plus Pegbing and the antiviral entecavir against two other combos: Aligo’s experimental treatment with entecavir, and Amoytop’s drug with entecavir.Aligos’ first attempt at a CHB treatment, ALG-010133, was an S-antigen transport-inhibiting oligonucleotide polymer. The molecule failed to significantly reduce hepatitis B virus surface antigen levels in a Phase I study.

Phase 1Drug ApprovalOligonucleotidesiRNAIND

15 Nov 2021

·www.biospace.com

BESREMi® (Ropeginterferon alfa-2b) approved by the US FDA

Nov. 15, 2021 12:24 UTC The US Food & Drug Administration (FDA) approved BESREMi® (active pharmaceutical ingredient Ropeginterferon alfa-2b), confirming the efficacy and safety for treatment of Polycythaemia Vera, a rare blood cancer disease. This approval was based on the clinical development program by AOP Orphan, the European pioneer in the field of rare and special diseases. VIENNA--(BUSINESS WIRE)-- In 2009, AOP Orphan Pharmaceuticals AG in-licensed the exclusive rights for clinical development and commercialization of Ropeginterferon alfa-2b in Polycythaemia Vera (PV), a rare disease, and other myeloproliferative neoplasms (MPNs) for European, Commonwealth of Independent States (CIS), and Middle Eastern markets. Based on a pivotal study development program, which included the studies PEGINVERA, PROUD-PV and CONTINUATION-PV the European Medicines Agency (EMA) authorized BESREMi® for the treatment of PV in February 2019. The whole clinical development program was designed and conducted by AOP Orphan in Europe. This press release features multimedia. View the full release here: Dr.  Rudolf Widmann Member of the Governing Board AOP Orphan International Copyright: Unkart PharmaEssentia Corp., AOP Orphan’s licensor, subsequently submitted the clinical data generated in the clinical development program for marketing authorisation of BESREMi® by the FDA in the United States. On March 12, 2021, according to PharmaEssentia, the FDA issued a Complete Response Letter for BESREMi® (Ropeginterferon alfa-2b) confirming the safety and efficacy of BESREMi® in compliance with FDA regulations. Now, after PharmaEssentia’s manufacturing sites in Taiwan have successfully passed the FDA’s GMP pre-approval inspection in September 2021, the FDA approved BESREMi® for sale in the United States. “FDA’s confirmation of BESREMi®’s safety and efficacy, based on AOP Orphan’s clinical study program and scientific knowledge, attests to the quality of work at our company" says Dr. Rudolf Widmann, Member of the Governing Board of AOP Orphan International. "We are extremely happy that now patients in the US have access for treating this rare blood cancer disease. This is the first of AOP Orphan’s ambitious projects to get medicinal products for rare and special diseases approved in the US. This achievement speaks not only to the scientific expertise and clinical development know-how of AOP Orphan, but also supports our company strategy to make drugs for rare and special diseases available worldwide." Clinical studies conducted by AOP Orphan Ropeginterferon alfa-2b is a specifically modified pegylated Interferon alpha 2b invented by PharmaEssentia’s CEO KC Lin. The application of this third-generation interferon to the treatment of PV was invented by Dr. Rudolf Widmann of AOP Orphan: The company has continually invested in its hematology and drug development know-how to get an injection pen for patients’ at-home self-administration approved. Several clinical studies have been conducted by the company leading to a successful marketing authorization of BESREMi® for the treatment of Polycythaemia Vera in the EU in February 2019, in Switzerland and in Taiwan in 2020, in Israel and Korea in 2021. Besides achieving high rates of complete hematologic responses including freedom of phlebotomy in 8 out of 10 patients, BESREMi® offers the possibility of disease modification and eventually operational cure in a subset of patients. This is exemplified by a decrease of mutant JAK2 allele burden (the disease-causing oncogene) from 37.3% at baseline to 7.3% in patients receiving Ropeginterferon alfa-2b, while an increase from 38.1% to 42.6% in the control group receiving hydroxyurea/best available therapy was observed (p<0.0001).1 Polycythaemia Vera patients in approximately 20 European countries are already being treated with Ropeginterferon alfa-2b. AOP Orphan is continuously working on increasing access for many more patients and continues the clinical development of BESREMi®. About BESREMi® BESREMi® is a long-acting, mono-pegylated proline interferon (ATC L03AB15). Its unique pharmacokinetic properties offer a new level of tolerability. BESREMi® is designed to be conveniently self-administered subcutaneously with a pen once every two weeks, or monthly after stabilization of hematological parameters. This treatment schedule is expected to lead to overall better safety, tolerability and adherence compared to conventional pegylated interferons. Ropeginterferon alfa-2b was discovered by PharmaEssentia, a long-term partner of AOP Orphan. For the EMA Summary of Product Characteristics please visit: AOP Orphan Pharmaceuticals GmbH (AOP Orphan) is an international pharmaceutical company with its headquarters in Vienna and a focus on rare and special diseases. Over the past 25 years, the company has become an established provider of integrated therapy solutions from its headquarters in Vienna. This development has been made possible by a continually high level of investment in research and development on the one hand and a highly consistent and pragmatic orientation towards the needs of all our stakeholders on the other - especially the patients and their families but also the doctors and care professionals treating them. 1

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

External Link

KEGG	Wiki	ATC	Drug Bank
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R&D Status

10 top approved records.

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

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


REAL-WORLD EXPERIENCE OF PEGYLATED INTERFERON ALFA-2B (EHA2024)	Not Applicable	Myeloproliferative Disorders JAK2V617F mutation \| CALR mutation \| MPL mutation	68	PEG IFNα-2b 180μg once a week	juphxiqsfu(uxkgtoqgrb) = ugemnnpyjw exwilpegjq (zkyigguleu ) View more	Positive	14 May 2024
EHA2024	Not Applicable	Polycythemia Vera \| Thrombocythemia, Essential	81	Peg-IFN-α-2b	grzlqtvpjb(uooljvuhdx) = gjojvbxoch omyyhjwvjq (cksbivlqqv )	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	siqgitykvn(ouuigdjppl) = All adverse reactions were controllable by temporary suspension of treatment. Serious complications and treatment related deaths were not observed. gxcmlzjgjj (flggcxsnoq )	Positive	26 Feb 2018
AACR2012	Phase 1/2	Melanoma	17	Decitabine	mjrbskbemx(pjlyhqeydw) = xlbmiahute brivdlzxje (yenrbqtuox ) View more	-	15 Apr 2012
IAS2003	Not Applicable	HIV Infections \| Hepatitis C, Chronic	121	peg INF plus RBV	kvhavhborn(zbpjckzdbu) = sgkqgmvhjg npzvvikmif (zzzoodazke )	-	01 Jan 2003

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