A prospective, multicentre clinical study based on GOLDEN model to guide nucleoside (acid) sequential combination with pegylated interferon for clinical cure of chronic hepatitis B patients

Start Date14 Jan 2025

Sponsor / Collaborator-

EUCTR2021-003665-35-BG

/ Not yet recruitingPhase 3

A Phase 3, Randomized, Open-Label, Parallel Arm Study to Evaluate the Efficacy and Safety of 180 mcg Peginterferon Lambda-1a (Lambda) Subcutaneous Injection for 48 Weeks in Patients with Chronic Hepatitis Delta Virus (HDV) Infection - LIMT-2

Start Date05 Oct 2022

Sponsor / Collaborator

Eiger BioPharmaceuticals, Inc.

ChiCTR2200056441

/ SuspendedPhase 4IIT

Pegylated interferon adding tenofovir alafenamide step treatment with nucleos(t)ide analogues-experienced hepatitis B e antigen-positive chronic hepatitis B priotity patients:A prospective, open, controlled multi-center study

Start Date18 Jan 2022

Sponsor / Collaborator-

100 Clinical Results associated with Peginterferon lambda-1a(ZymoGenetics, Inc.)

100 Translational Medicine associated with Peginterferon lambda-1a(ZymoGenetics, Inc.)

100 Patents (Medical) associated with Peginterferon lambda-1a(ZymoGenetics, Inc.)

Literatures (Medical) associated with Peginterferon lambda-1a(ZymoGenetics, Inc.)

01 Nov 2024·VIRUS RESEARCH

Interferon alpha induces a stronger antiviral effect than interferon lambda in HBV/HDV infected humanized mice

Article

Author: Duehren, Sarah ; Oka, Shiro ; Koh, Christopher ; Uchida, Takuro ; Uprichard, Susan L ; Glenn, Jeffrey ; Chayama, Kazuaki ; Hiraga, Nobuhiko ; Heller, Theo ; Etzion, Ohad ; Tsuge, Masataka ; Dahari, Harel ; Cotler, Scott J

Recent studies indicate that treatment of chronic hepatitis D virus (HDV) with either pegylated interferon (IFN)λ or pegylated IFNα monotherapy leads to a dramatic decline in HDV RNA. Herein, we investigated the innate antiviral efficacy of IFNλ and IFNα in humanized mice that lack an adaptive immune response. Humanized mice were either co-infected with hepatitis B virus (HBV) and HDV simultaneously, or HDV infection was performed subsequent to HBV infection (i.e., superinfected). After steady viral replication was achieved, mice received either IFNλ (n = 6) or IFNα (n = 7) for 12 (or 13) weeks. Pretreatment median levels of serum HBV DNA (8.8 [IQR:0.2] log IU/ml), HDV RNA (9.8 [0.5] log IU/ml), HBsAg (4.0 [0.4] log IU/ml) and human albumin, hAlb (6.9 [0.1] log ng/mL) were similar between mice treated with IFNα or IFNλ and between those coinfected versus superinfected. Compared to mice treated with IFNλ, mice treated with IFNα had a significantly greater decline in HBV, HDV, and HBsAg levels. In conclusion, IFNα induces stronger inhibition of HBV and HDV than IFNλ in humanized mice that lack an adaptive immune response. Further studies are needed to assess the respective role of the combined innate-and adaptive-immune systems in the treatment of HBV and HDV with IFNα and IFNλ.

02 Dec 2023·Expert opinion on biological therapy

Bulevirtide and emerging drugs for the treatment of hepatitis D

Review

Author: Han, Steven-Huy B ; Yang, Jamie O ; Xu, Helen Y ; Chen, Phillip H

INTRODUCTION:

Hepatitis delta virus (HDV) causes acute and chronic liver disease that requires the co-infection of the Hepatitis B virus and can lead to significant morbidity and mortality. Bulevirtide is a recently introduced entry inhibitor drug that acts on the sodium taurocholate cotransporting peptide, thereby preventing viral entry to target cells in chronic HDV infection. The mainstay of chronic HDV therapy prior to bulevirtide was interferon alpha, which has an undesirable side effect profile.

AREAS COVERED:

We review bulevirtide data from recent clinical trials in Europe and the United States. Challenges to development and implementation of bulevirtide are discussed. Additionally, we review ongoing trials of emerging drugs for HDV, such as pegylated interferon lambda and lonafarnib.

EXPERT OPINION:

Bulevirtide represents a major shift in treatment for chronic HDV, for which there is significant unmet need. Trials that compared bulevirtide in combination with interferon alpha vs interferon alpha monotherapy demonstrated significant increase in virologic response. Overall, treatment with different doses of bulevirtide were comparable. Bulevirtide was generally well tolerated, and no serious adverse events occurred. Understanding the true prevalence of HDV, as well as continued studies of emerging drugs will prove valuable to the larger goal of eradication of Hepatitis D.

01 Dec 2023·Expert opinion on emerging drugs

Emerging drugs for hepatitis D.

Article

Author: Yurdaydin, Cihan ; Keskin, Onur

INTRODUCTION:

Chronic hepatitis delta (CHD) is the most severe form of chronic viral hepatitis. Until recently, its treatment consisted of pegylated interferon alfa (pegIFN) use.

AREAS COVERED:

Current and new drugs for treating CHD. Virus entry inhibitor bulevirtide has received conditional approval by the European Medicines Agency. Prenylation inhibitor lonafarnib and pegIFN lambda are in phase 3 and nucleic acid polymers in phase 2 of drug development.

EXPERT OPINION:

Bulevirtide appears to be safe. Its antiviral efficacy increases with treatment duration. Combining bulevirtide with pegIFN has the highest antiviral efficacy short-term. The prenylation inhibitor lonafarnib prevents hepatitis D virus assembly. It is associated with dose-dependent gastrointestinal toxicity and is better used with ritonavir which increases liver lonafarnib concentrations. Lonafarnib also possesses immune modulatory properties which explains some post-treatment beneficial flare cases. Combining lonafarnib/ritonavir with pegIFN has superior antiviral efficacy. Nucleic acid polymers are amphipathic oligonucleotides whose effect appears to be a consequence of phosphorothioate modification of internucleotide linkages. These compounds led to HBsAg clearance in a sizable proportion of patients. PegIFN lambda is associated with less IFN typical side effects. In a phase 2 study it led to 6 months off treatment viral response in one third of patients.

News (Medical) associated with Peginterferon lambda-1a(ZymoGenetics, Inc.)

05 Mar 2025

·www.prnewswire.com

Global Interferons Market is Predicted to Reach ~USD 14 Billion by 2032 | DelveInsight

The increasing occurrence of chronic and infectious diseases is the main driver of the rising demand for interferon. Furthermore, advancements in interferon production and ongoing research and development of innovative interferon therapies are key factors fueling the expansion of the interferon market from 2025 to 2032. LAS VEGAS, March 5, 2025 /PRNewswire/ -- DelveInsight's Interferons Market Insights report provides the current and forecast market analysis, individual leading interferons companies' market shares, challenges, interferons market drivers, barriers, trends, and key market interferons companies in the market. Key Takeaways from the Interferons Market Report As per DelveInsight estimates, North America is anticipated to dominate the global interferons market during the forecast period. In the application segment of the interferon market, the leukemia category captured a significant revenue share in 2024. Notable interferons companies such as Bayer AG, Amega Biotech, Biogen, Merck KGaA, Novartis AG, Pfizer Inc., F. Hoffmann-La Roche Ltd., Biosidus, AOP Orphan Pharmaceuticals GmbH, Reliance Life Sciences, and several others, are currently operating in the interferons market. In September 2022, Eiger BioPharmaceuticals, a commercial-stage biopharmaceutical company focused on the development of innovative therapies for hepatitis delta virus (HDV) and other serious diseases, provided an update on the status of its planned request for emergency use authorization (EUA) of peginterferon lambda for the treatment of patients with mild-to-moderate COVID-19 based on its most recent communications with the U.S. Food and Drug Administration (FDA). To read more about the latest highlights related to the interferons market, get a snapshot of the key highlights entailed in the Global Interferons Market Report Interferons Overview Interferons (IFNs) are a group of signaling proteins that play a critical role in the immune response, particularly in defending against viral infections and modulating the activity of immune cells. They are classified into three main types: Type I (such as IFN-α and IFN-β), Type II (IFN-γ), and Type III (IFN-λ). Type I interferons are primarily produced in response to viral infections and function by activating antiviral pathways in host cells, inhibiting viral replication, and enhancing the activity of natural killer (NK) cells. IFN-γ, the sole Type II interferon, is crucial for activating macrophages and promoting adaptive immune responses, particularly in bacterial and tumor immunity. Type III interferons share functional similarities with Type I IFNs but act more selectively on epithelial cells, making them important in mucosal immunity. Beyond their antiviral properties, interferons have significant roles in cancer immunotherapy and autoimmune diseases. They enhance antigen presentation, stimulate cytotoxic T cells, and modulate the tumor microenvironment, contributing to immune surveillance against malignancies. Clinically, recombinant interferons have been used to treat conditions such as hepatitis B and C, multiple sclerosis, and certain cancers. However, prolonged interferon therapy can lead to adverse effects, including flu-like symptoms, fatigue, and autoimmune complications. Recent research is focused on optimizing interferon-based therapies and combining them with immune checkpoint inhibitors or other immunomodulators to improve efficacy while minimizing toxicity. Interferons Market Insights North America holds the largest interferons market share due to a strong presence of biopharmaceutical companies, robust R&D investments, and high healthcare expenditure. The U.S. market, in particular, benefits from a well-established regulatory framework and widespread adoption of advanced biotherapeutics. Meanwhile, Europe follows closely, with key contributions from Germany, France, and the UK, where government support for biotech innovation and access to novel biologics drive market expansion. In the Asia-Pacific region, the interferon market is witnessing rapid growth, fueled by rising healthcare infrastructure, an increasing prevalence of infectious diseases, and government initiatives to boost biopharmaceutical production. China and India are emerging as major players, with domestic companies investing heavily in biosimilar development and expanding manufacturing capacities. Latin America and the Middle East & Africa are also showing potential, albeit at a slower pace, due to improving healthcare access and growing awareness of biologic treatments. However, market expansion in these regions is challenged by high drug costs and regulatory hurdles, which may impact the adoption of interferon therapies. To know more about why North America is leading the market growth in the interferons market, get a snapshot of the Interferons Market Outlook Interferons Market Dynamics The interferons market is driven by their critical role in treating viral infections, autoimmune diseases, and various cancers. Interferons (IFNs) are a class of cytokines that modulate the immune response, making them valuable in antiviral therapies (such as hepatitis B and C), multiple sclerosis, and oncology applications. The increasing prevalence of these diseases, along with rising research into novel interferon-based therapies, continues to fuel market growth. However, the market faces challenges due to the emergence of alternative therapies, such as monoclonal antibodies and small-molecule inhibitors, which offer higher efficacy and fewer side effects. One of the key factors influencing market dynamics is the shift from traditional interferon therapies to newer, more targeted treatments. For instance, in the treatment of hepatitis C, direct-acting antiviral agents (DAAs) have largely replaced interferon-based regimens due to their superior cure rates and reduced adverse effects. Similarly, in multiple sclerosis, oral therapies and monoclonal antibodies such as ocrelizumab and natalizumab have overshadowed interferon-beta treatments. Despite this, interferons remain relevant in certain applications, such as rare cancers and specific immune disorders where alternative treatments are not as effective. Another factor shaping the interferons market is the regulatory landscape. Interferons are biologic drugs, meaning they are subject to stringent approval processes and high production costs. The development of biosimilar interferons has the potential to make these therapies more accessible, especially in emerging markets. However, biosimilars face challenges in gaining market traction due to concerns about immunogenicity and physician preference for established brands. Companies investing in next-generation interferons with improved efficacy and safety profiles may have an opportunity to capture a share of this evolving market. Looking ahead, the future of the interferons market will be shaped by ongoing innovation, competitive pressures, and the need for cost-effective biologics. While traditional interferon therapies may continue to decline in some areas, their role in niche indications and combination therapies could sustain market demand. Companies focusing on improving delivery methods, reducing side effects, and exploring novel interferon applications in immuno-oncology and rare diseases may unlock new growth opportunities in this evolving landscape. Get a sneak peek at the interferons market dynamics @ Interferons Market Dynamics Analysis Interferons Market Assessment Interferons Market Segmentation Interferons Market Segmentation By Type: Alpha, Beta, and Gamma Interferons Market Segmentation By Application: Hepatitis B, Hepatitis C, Leukemia, Multiple Sclerosis, and Others Interferons Market Segmentation By Distribution Channel: Hospital Pharmacies, Retail Pharmacies, and Others Interferons Market Segmentation By Geography: North America, Europe, Asia-Pacific, and Rest of World Porter's Five Forces Analysis, Product Profiles, Case Studies, KOL's Views, Analyst's View Which MedTech key players in the interferons market are set to emerge as the trendsetter explore @ Interferons Companies Table of Contents Interested in knowing the interferons market by 2032? Click to get a snapshot of the Interferons Market Trends Related Reports Multiple Sclerosis Market Multiple Sclerosis Market Insights, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key multiple sclerosis companies, including Immune Response BioPharma, Inc., Clene Nanomedicine, Sanofi, Merck Healthcare KGaA, TG Therapeutics, Inc., Apimeds Inc., Bayer HealthCare, Novartis, Biogen, Alkermes, Genentech, among others. Multiple Sclerosis Pipeline Multiple Sclerosis Pipeline Insight – 2025 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key multiple sclerosis companies, including Novartis, Sanofi, Immunic, Biocad, Apimeds, Genentech (Roche), Merck, AB Science, Apurano Pharmaceuticals, Biogen, Tiziana Life Sciences, Worg Pharmaceuticals, Antisense Therapeutics, RemeGen, Atara Biotherapeutics, Contineum Therapeutics, Stem Cell Medicine Ltd., Ever Supreme Bio Technology Co., Ltd., ImCyse, among others. Chronic Hepatitis B Market Chronic Hepatitis B Market Insights, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key chronic hepatitis B companies, including GlaxoSmithKline, Ionis Pharma, Beijing Continent Pharmaceutical, Ascletis Pharmaceuticals, Vir Biotechnology, Brii Biosciences, Janssen, Arrowhead Pharmaceuticals, among others. Chronic Hepatitis B Pipeline Chronic Hepatitis B Pipeline Insight – 2025 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key chronic hepatitis B companies, including Vedanta Biosciences, Gilead Sciences, Dong-A ST Co, Assembly Biosciences, Arbutus Biopharma, Vir Biotechnology, Antios Therapeutics, Ascletis Pharmaceuticals, Shanghai HEP Pharmaceutical, Romark Laboratories, Qilu Pharmaceutical, Golden Biotechnology, Sunshine Lake Pharma, Ascentage Pharma, GlaxoSmithKline, Janssen Sciences, Henlix, Enyo Pharma, Tasly Tianjin Biopharmaceutical, Brii Biosciences, Vaxine Pty Ltd, Vaccitech limited, Zhejiang Palo Alto Pharmaceuticals, Suzhou Ribo Life Science, PharmaEssentia, Nucorion Pharmaceuticals, Jiangsu HengRui Medicine, Enanta Pharmaceuticals, Chong Kun Dang Pharmaceutical, Guangzhou Lupeng Pharmaceutical, VenatoRx Pharmaceuticals, Zhimeng Biopharm, among others. About DelveInsight DelveInsight is a leading Business Consultant, and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Contact Us Shruti Thakur [email protected] +14699457679 Logo: SOURCE DelveInsight Business Research, LLP WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Immunotherapy

19 Feb 2025

·www.biospace.com

Biopharma Bankruptcies Still At Peak, With Little Relief in Sight

iStock, Yutthana Gaetgeaw 2023 marked the most bankruptcies in biopharma in more than a decade, with 14 companies filing for Chapter 11 protection. The number remained high in 2024. Biopharma bankruptcies are still at higher-than-normal levels, with 2024 seeing 13 firms go under in this way—just one less than the industry’s 10-year high of 14 in 2023—underscoring the perilous fundraising situation that has persisted since the pandemic bubble burst. “Chapter 11 is really just the tip of the iceberg,” Cristine Schwarzman, a partner in Ropes & Gray’s business restructuring practice, told BioSpace in an email. While the bankruptcy code is the most commonly reported way that companies shut down, it’s not the only way. “Many more biotechs go through ABC proceedings and just dissolve, because those processes are less expensive and quicker, even though they do not provide the same benefits as the ‘free and clear’ provisions of the bankruptcy code,” Schwarzman said. Prior to 2023, the highest number of biopharma bankruptcies since 2010 came in 2019 when seven companies filed for Chapter 11 protection. David McIntosh, also a partner at Ropes & Gray in the life sciences and intellectual property transactions practice, said the key driver of this recent peak is fundraising challenges, particularly as interest rates have risen and strained access to capital. There has also been economic uncertainty due to the political environment, leading to more restrained investing, McIntosh explained. “The public markets have been cool for biotech companies, and private investors, like VCs, are being more selective in which (and how many) companies they are willing to invest in,” he told BioSpace . in an email. Meanwhile, Big Pharma has not been as quick to deal as analysts and investors had hoped, and the larger companies have also cut back on R&D expenditures. This challenging funding environment follows the pandemic boom, which saw an influx of funds across the life sciences. “The ease with which companies were able to raise capital during the pandemic resulted in biotech companies taking on more debt financing than previously in the life sciences industry,” Schwarzman said. Because of the high rate of debt financings, more companies had to go through the bankruptcy process to “de-lever” their balance sheets, she added. “I think it is also safe to say that during the pandemic, a number of private biotech companies went public that might not have been able to in normal market times,” McIntosh said. These public companies are more likely to seek bankruptcy protection because they typically have a higher valuation, more complex capital structure and investors with access to capital to fund the Chapter 11 process, Schwarzman said. Smaller private companies, on the other hand, tend to be able to wrap things up through state court processes. “To be clear, however, both private and public biotech companies are facing financial pressure right now,” Schwarzman added. Unfortunately, Schwarzman and McIntosh see the trend continuing this year. Due to geopolitical uncertainty “and the increasing likelihood that interest rates will at a minimum not be cut to deal with the continuing inflationary environment,” McIntosh said, “we do not expect these trends to fall off.” Beginning of the End To McIntosh, the most surprising bankruptcy of 2024 was Eiger BioPharmaceuticals, a metabolic disease biotech that was advancing peginterferon lambda for chronic hepatitis delta until a liver safety signal arose in a Phase III trial. “It had raised a lot of money and had a lot of interesting assets, but experienced a Phase III failure in 2023, which seemed to be the beginning of the end,” McIntosh said. Eiger sold off its assets, with some landing at Amylyx Pharmaceuticals for future development. Amylyx paid $35 million for the glucagon-like peptide-1 receptor antagonist avexitide, which is expected to begin a Phase III trial this quarter . This is a fairly typical path for the assets left behind in a biotech bankruptcy, McIntosh explained. The intellectual property is sold to other companies, presenting the new owner with the opportunity to use the assets to attract new financing at a lower valuation, he said; it also gives the drugs a second chance. Another major bankruptcy of 2024 was Gritstone bio, which filed in October in an effort to save its R&D operations. The vaccines-focused biotech was pursuing a stalking horse transaction, when a party swoops in to buy out a bankrupt company’s assets prior to a court auction process. Ultimately, Gritstone’s assets were auctioned off for $21.2 million, according to a Jan. 3 filing. Gritstone was optimistic about Phase II results for its Granite program in September 2024, which showed a 21% relative risk reduction of progression or death in patients taking the study medication versus standard of care. But the data needed more time to mature and Gritstone was running out of runway, with just $61.7 million on hand, leading to the bankruptcy filing. Cell therapy biotech Athersys was another company to file, going the stalking horse route and selling its assets to Healios for around $2 million in January 2024. Athersys had been developing its MultiStem off-the-shelf cell therapy since 1994 in ischemic stroke in partnership with Healios. Other indications included traumatic injury and acute respiratory distress syndrome. A Phase III trial in stroke that read out in October 2023 was unsuccessful . This year, the bankruptcies have already started. According to a Jan. 29 SEC filing , Flagship Pioneering spinout Omega Therapeutics had until Feb. 10 to commence bankruptcy proceedings and begin to wind down operations, likely involving a sale process with Pioneering Medicines, an affiliate of Flagship Pioneering. The news came just over a year after Omega struck an obesity deal with Novo Nordisk. “As long as the public markets disfavor biotech companies, and private investors shy away from ‘riskier’ early-stage investments,” McIntosh said, “the trend will continue.” A note about the data: BioSpace ’s last bankruptcy analysis clocked 28 bankruptcies for 2023 as of October of that year. Our new analysis uses narrower criteria, including only companies making therapeutics. Our source for bankruptcies also shifted to S&P Capital IQ and company SEC filings.

Phase 3Clinical ResultCell TherapyPhase 2

02 Apr 2024

·www.biospace.com

Eiger Files for Bankruptcy, Plans to Shutter Operations After Difficult Year

Pictured: A U.S. federal bankruptcy courthouse building/iStock, GussWilder Eiger BioPharmaceuticals on Monday announced that it has voluntarily filed for bankruptcy and has kicked off the process of selling its assets and winding down the company’s operations. The California-based biotech has filed for Chapter 11 protection with the Bankruptcy Court for the Northern District of Texas, and has also submitted customary “first day” motions. If granted, the motion will provide Eiger some relief allowing it to transition into bankruptcy while it meets the company’s commitments to its stakeholders without “material disruptions” to its ordinary operations, according to the announcement. Eiger will sell all its assets during the bankruptcy case as it prepares for “an orderly wind down” of its operations. As part of the process, the biotech has inked a “stalking horse” agreement with rare disease player Sentynl Therapeutics which has agreed to purchase Zokinvy (lonafarnib), a farnesyltransferase inhibitor approved to treat the rare and progressive genetic disease Hutchinson-Gilford progeria syndrome. Sentynl will pay up to $26 million for Zokinvy, with the final price subject to other adjustments including per diem reductions. Zokinvy is an oral small molecule drug that blocks the farnesyltransferase protein. It is also approved for use in processing-deficient progeroid laminopathies with specific genetic mutations. The companies expect to close the sale by April 24, 2024. As part of its bankruptcy filing, other bidders can also submit competing offers for Eiger’s assets through a court-supervised process. Eiger’s bankruptcy filing on Monday caps off a difficult year for the biotech. In September 2023, it announced that it was discontinuing the Phase III LIMT-2 study of its candidate peginterferon lambda for chronic hepatitis delta. A quarterly review by a Data Safety Monitoring Board (DSMB) found concerning safety signals associated with peginterferon lambda. Four patients who received the investigational therapy developed hepatobiliary events, which led to liver compensation, leading the DSMB to recommend the study’s discontinuation. In September 2022, the FDA also rejected Eiger’s application for an Emergency Use Authorization for peginterferon lambda, which the biotech was proposing for the treatment of mild-to-moderate COVID-19. Following this rejection, Eiger in June 2023 laid off 25% of its workers in a sweeping reprioritization and savings program. The initiative also included a pivot to its GLP-1 receptor antagonist avexitide, which at the time was being developed for post-bariatric hypoglycemia and congenital hyperinsulinism. Eiger expected the cost-cutting measures to support its operations through the fourth quarter of 2024. Tristan Manalac is an independent science writer based in Metro Manila, Philippines. Reach out to him on LinkedIn or email him at tristan@tristanmanalac.com or tristan.manalac@biospace.com.

Phase 3Drug ApprovalAcquisitionPriority ReviewAccelerated Approval

100 Deals associated with Peginterferon lambda-1a(ZymoGenetics, Inc.)

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R&D Status

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Indication	Highest Phase	Country/Location	Organization	Date
COVID-19	Phase 3	-	Eiger BioPharmaceuticals, Inc.	17 Mar 2022
Hepatitis D, Chronic	Phase 3	United States	Eiger BioPharmaceuticals, Inc.	21 Dec 2021
Hepatitis D, Chronic	Phase 3	Belgium	Eiger BioPharmaceuticals, Inc.	21 Dec 2021
Hepatitis D, Chronic	Phase 3	Bulgaria	Eiger BioPharmaceuticals, Inc.	21 Dec 2021
Hepatitis D, Chronic	Phase 3	France	Eiger BioPharmaceuticals, Inc.	21 Dec 2021
Hepatitis D, Chronic	Phase 3	Georgia	Eiger BioPharmaceuticals, Inc.	21 Dec 2021
Hepatitis D, Chronic	Phase 3	Germany	Eiger BioPharmaceuticals, Inc.	21 Dec 2021
Hepatitis D, Chronic	Phase 3	Israel	Eiger BioPharmaceuticals, Inc.	21 Dec 2021
Hepatitis D, Chronic	Phase 3	Italy	Eiger BioPharmaceuticals, Inc.	21 Dec 2021
Hepatitis D, Chronic	Phase 3	Moldova	Eiger BioPharmaceuticals, Inc.	21 Dec 2021

Clinical Result

Indication

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT01866930 (DIMENSION, CTgov)	Phase 3	Coinfection \| HIV Infections \| Hepatitis C, Chronic	453	Lambda+DCV+Ribavirin (Cohort A: HCV GT-2 or GT-3)	lxoxapupaz = anxidptvct opisawldcr (tqcdtmvdpb, chatrgomne - zxfmsekxfq) View more	-	13 Jun 2023
				Lambda+DCV+Ribavirin (Cohort B: HCV GT-1 or GT-4)	lxoxapupaz = vurqacalat opisawldcr (tqcdtmvdpb, qcbilfebtk - rzozrjncjs) View more
NCT02765802 (LIMT, CTgov)	Phase 2	Hepatitis D, Chronic	33	Peginterferon Lambda-1A (Lambda 180 μg)	wdujczwkmp(qxaugwirks) = tcvgypjcku qxfnlolvwj (cxehwurnuk, 1.81) View more	-	17 Jan 2023
				Peginterferon Lambda-1A (Lambda 120 μg)	wdujczwkmp(qxaugwirks) = xnanmanics qxfnlolvwj (cxehwurnuk, 2.38) View more
NCT04343976 (CTgov)	Phase 2	COVID-19	14	Pegylated interferon lambda (Lambda Treatment)	sggnzcdtvq = fxnsubwbcf uhevdhvxul (mptkwyybdu, mcvdpwiqkx - mvehpouzed) View more	-	21 Jul 2022
				Pegylated interferon lambda (Saline Placebo)	sggnzcdtvq = zcnfcyzzfv uhevdhvxul (mptkwyybdu, lqqvlvjzsj - plwddoejos) View more
NCT04354259 (Pubmed \| Lancet Respir Med) Manual	Phase 2	COVID-19	60	Peginterferon lambda 180 μg	lqxuzxipjb(ymgolxdgqr): 2.42, P-Value = 0.041 View more	Positive	01 May 2021
				Placebo
NCT04331899 (COVID-Lambda, CTgov)	Phase 2	COVID-19	120	Lambda (Lambda)	ghbdxqlnle(hjesdlstka) = ldmrvzlczj vrdxaubzaq (rovplflymo, nqhuhbjzox - yqrtakaydz) View more	-	22 Apr 2021
				Placebo+Lambda (Placebo)	ghbdxqlnle(hjesdlstka) = wadnkvldoj vrdxaubzaq (rovplflymo, bxengtfyfj - vsjslqania) View more
NCT04331899 (Pubmed \| Nat Commun)	Phase 2	COVID-19	120	Peginterferon Lambda-1a	bvxykncryb(bckjujwbmt) = ylxhnkbndl fxoyqwtafy (fapnmtprmk ) View more	Negative	30 Mar 2021
				Placebo	bvxykncryb(bckjujwbmt) = agjswlyhnq fxoyqwtafy (fapnmtprmk ) View more
NCT01741545 (MAGNITUDE, CTgov)	Phase 3	Hemophilia \| Hepatitis C, Chronic	71	Lambda+daclatasvir+Ribavirin (Cohort A)	obasokobyr = mxmxhecxdb iidatpzpzi (gqoxosmcei, iagbhomjew - msezfugusi) View more	-	24 Jun 2019
				Lambda+daclatasvir+Ribavirin (Cohort B)	obasokobyr = ezbnzrkaii iidatpzpzi (gqoxosmcei, woyvaxbfga - wsudnfettu) View more
NCT01598090 (PEDESTAL, CTgov)	Phase 3	Chronic hepatitis C genotype 1	881	TVR+Peginterferon Lambda-1a+RBV (Part A: Peginterferon Lambda-1a + RBV + TVR (Open Label))	dxekkhzcsr = fqnalaqrbl xnosvlbzqk (ojfihfnlcw, nzzmrerudp - bdgfatrjwv) View more	-	21 May 2019
				TVR+Peginterferon Lambda-1a+RBV (Part B: Peginterferon Lambda-1a + RBV + TVR)	cbmfgdbbnp = vifwhdueeu fzwryibkds (leszqfdnvu, fpqbibyrgt - tmrrdrjljm) View more
LIMT HDV study (EASL2019)	Not Applicable	Hepatitis D, Chronic	33	Lambda 120 μg	dqdgewphzx(fblkjbhpzk) = tqpexhgzko hytsxjikkn (syepkswivj, ±1.4)	-	11 Apr 2019
				Lambda 180 μg	dqdgewphzx(fblkjbhpzk) = udxhpqzqxc hytsxjikkn (syepkswivj, ±1.4)
NCT01866930 (Pubmed \| J Interferon Cytokine Res) Manual	Phase 3	HIV Infections \| Hepatitis C	300	Ribavirin+Daclatasvir+pegylated interferon-lambda-1a (HCV genotype (GT)-2 or -3)	hkvakwrlap(arrtzujqwy) = ykpeszmwcv goksfnhbwt (zqqrihzdla ) View more	Positive	01 Mar 2017
				Ribavirin+Daclatasvir+pegylated interferon-lambda-1a (HCV GT-1(a or b) or -4)	hkvakwrlap(arrtzujqwy) = cnflgswjzx goksfnhbwt (zqqrihzdla ) View more

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