Delving into the Latest Updates on Peginterferon lambda-1a(ZymoGenetics, Inc.) with Synapse

Overview

Basic Info

Drug Type

Interferons

Synonyms

Lambda, PEG-interferon lambda, PEG-interleukin-29

+ [6]

Target

IFNLR1

Mechanism

IFNLR1 agonists(interferon lambda receptor 1 agonists)

Therapeutic Areas

Infectious DiseasesDigestive System DisordersRespiratory Diseases+ [1]

Active Indication

COVID-19Hepatitis D, Chronic

Inactive Indication

Chronic hepatitis C genotype 1Chronic hepatitis C genotype 1bChronic hepatitis C genotype 3+ [7]

Originator Organization

ZymoGenetics, Inc.

Active Organization

Eiger BioPharmaceuticals, Inc.

Inactive Organization

Bristol Myers Squibb Co.

ZymoGenetics, Inc.

Drug Highest PhasePhase 3

First Approval Date-

RegulationOrphan Drug (EU), Fast Track (US), Breakthrough Therapy (US)

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Structure/Sequence

Sequence Code 199195

Source: *****

The Phase 3 LIMT-2 study will evaluate the safety and efficacy of Peginterferon Lambda treatment for 48 weeks with 24 weeks follow-up compared to no treatment for 12 weeks in patients chronically infected with HDV. The primary analysis will compare the proportion of patients with HDV RNA < LLOQ at the 24-week post-treatment visit in the Peginterferon Lambda treatment group vs the proportion of patients with HDV RNA < LLOQ at the Week 12 visit in the no-treatment comparator group.

Start Date21 Dec 2021

Sponsor / Collaborator

Eiger BioPharmaceuticals, Inc.

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

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

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

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3,234

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

01 Jan 2025·Advances in Radiation Oncology

Pegylated Interferon Combined With Low-Dose Total Skin Electron Beam Therapy for Advanced Stage Mycosis Fungoides: Two Case Reports and Literature Review

Article

Author: Elsayad, Khaled ; Stadler, Rudolf ; Eich, Hans Theodor

06 Dec 2024·Hematology

Pegylated interferon: the who, why, and how

Review

Author: Kiladjian, Jean-Jacques

AbstractInterferon alpha (IFN-α) is a fascinating molecule with many biological properties yet to be fully understood. Among these properties, several have demonstrated usefulness for targeting malignant cells, including hematopoietic cells from patients with myeloproliferative neoplasms. Indeed, IFN-α has been used for decades across all myeloproliferative neoplasms, but only recently a new form, ropegIFN-α2b, was approved to treat patients with polycythemia vera. Many phase 2 and more recently phase 3 studies have demonstrated IFN-α's promise in treating patients with essential thrombocythemia and early-stage myelofibrosis. In addition, although not approved in that situation, IFN-α is the only cytoreductive therapy that can be used during pregnancy. Today, IFN-α is a key medicine for polycythemia vera and essential thrombocythemia, while its place in the management of myelofibrosis must be better defined. The advantages of IFN therapy include a well-known safety profile, high rates of clinical and molecular responses, and a unique ability to deeply reduce the mutant allele burden of most of the driver mutations causing myeloproliferative neoplasms. Recent preliminary data from prospective studies suggest that molecular responses may be correlated with prolonged event-free survival, raising the hope that IFN therapy may ultimately alter the natural history of many diseases.

05 Dec 2024·New England Journal of Medicine

Xalnesiran with or without an Immunomodulator in Chronic Hepatitis B

Article

Author: Zhang, Wenhong ; Huang, Yan ; Leerapun, Apinya ; Tang, Hong ; Kim, Dong Joon ; Wat, Cynthia ; Das, Sudip ; Xie, Qing ; Yuen, Man-Fung ; Asselah, Tarik ; Cheng, Cong ; Canducci, Filippo ; Hou, Jinlin ; Catanese, Maria Teresa ; Chen, Ethan ; Triyatni, Miriam ; Yang, Sheng-Shun ; Bo, Qingyan ; Pavlovic, Vedran ; Chuang, Wan-Long ; Peng, Cheng-Yuan ; Chughlay, Farouk ; Guerreiro, Nelson ; Upmanyu, Ruchi ; Patil, Avinash ; Kazma, Rémi ; Su, Wei-Wen ; Kakrana, Priyanka ; Avihingsanon, Anchalee ; Morano Amado, Luis Enrique ; Glavini, Katerina ; Surujbally, Bernadette ; Hua, Rui ; Gane, Edward ; Liang, Xieer ; Kao, Jia-Horng

BACKGROUNDXalnesiran, a small interfering RNA molecule that targets a conserved region of the hepatitis B virus (HBV) genome and silences multiple HBV transcripts, may have efficacy, with or without an immunomodulator, in patients with chronic HBV infection.METHODSWe conducted a phase 2, multicenter, randomized, controlled, adaptive, open-label platform trial that included the evaluation of 48 weeks of treatment with xalnesiran at a dose of 100 mg (group 1), xalnesiran at a dose of 200 mg (group 2), xalnesiran at a dose of 200 mg plus 150 mg of ruzotolimod (group 3), xalnesiran at a dose of 200 mg plus 180 μg of pegylated interferon alfa-2a (group 4), or a nucleoside or nucleotide analogue (NA) alone (group 5) in participants with chronic HBV infection who had virologic suppression with NA therapy. The primary efficacy end point was hepatitis B surface antigen (HBsAg) loss (HBsAg level, <0.05 IU per milliliter) at 24 weeks after the end of treatment. Safety was also assessed.RESULTSAmong 159 participants (30, 30, 34, 30, and 35 in groups 1 through 5, respectively), the primary end-point event occurred in 7% (95% confidence interval [CI], 1 to 22) of those in group 1, in 3% (95% CI, 0 to 17) of those in group 2, in 12% (95% CI, 3 to 28) of those in group 3, in 23% (95% CI, 10 to 42) of those in group 4, and in none (95% CI, 0 to 10) of those in group 5. In groups 1 through 5, respectively, HBsAg seroconversion occurred in 3%, none, 3%, 20%, and none of the participants at 24 weeks after the end of treatment. HBsAg loss with or without seroconversion occurred only in participants with a screening HBsAg level below 1000 IU per milliliter. In groups 1 through 5, respectively, grade 3 or 4 adverse events occurred in 17%, 10%, 18%, 50%, and 6% of the participants, with the most frequent event being an elevated alanine aminotransferase level.CONCLUSIONSAmong participants with chronic HBV infection who had virologic suppression with NA therapy, treatment with xalnesiran plus an immunomodulator resulted in HBsAg loss at 24 weeks after the end of treatment in a substantial percentage of participants. Grade 3 or 4 adverse events were not uncommon. (Funded by F. Hoffmann-La Roche; Piranga ClinicalTrials.gov number, NCT04225715.).

36

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

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

13 Sep 2023

·www.fiercebiotech.com

Eiger ends hepatitis med's journey after liver damage reported, hunts for cash

Eiger BioPharmaceuticals CEO David Apelian, M.D., Ph.D., called the discontinuation “disappointing” and pledged to work with FDA regulators toward an early termination. Eiger BioPharmaceuticals is finally putting a pin in efforts to find a home for peginterferon lambda, a drug once tried in COVID-19 that has now failed in a study for chronic hepatitis delta. In a short update Tuesday afternoon, the company said the phase 3 LIMT-2 study is being discontinued based on the recommendation of the data safety monitoring board after a quarterly safety review. The board recommended the trial be ended after four patients experienced hepatobiliary events that resulted in liver decompensation. Eiger CEO David Apelian, M.D., Ph.D., called the discontinuation “disappointing” and pledged to work with FDA regulators toward an early termination “in the interest of patient safety.” The open-label study just completed enrollment of 158 patients in 12 countries in July. In connection with the discontinuation, Eiger is no longer actively seeking a worldwide licensing partner for peginterferon lambda. In June, Eiger pledged to find companies to work with on their virology assets, which included lonafarnib, too. But now, “Eiger is no longer in active discussions with potential partners for a worldwide license for peginterferon lambda,” Apelian said Tuesday afternoon. While Eiger’s priorities had already shifted toward phase 3 metabolic disease treatment avexitide, work on the chronic hepatitis delta indication had continued, albeit with limited spending. Now, Apelian said the focus is completely on avexitide, but funding will need to be found for the company’s further development activities. "As we look toward the future for Eiger, we will continue to execute on our strategic pivot, announced on June 29 of this year, and seek the financial resources required to advance the company's development activities on avexitide in hyperinsulinemic hypoglycemia indications,” Apelian said. Eiger remains on the hunt to find partners for its remaining virology asset lonafarnib, marketed as Zokinvy. The therapy, which is FDA approved for Hutchinson-Gilford progeria syndrome, has since been tested with ritonavir in a phase 3 study for chronic hepatitis delta virus.

Phase 3Drug ApprovalLicense out/in

13 Sep 2023

·firstwordpharma.com

Eiger halts Phase III chronic hepatitis delta study, ends licensing talks

Eiger BioPharmaceuticals announced that it is discontinuing the Phase III LIMT-2 study of peginterferon lambda in patients with chronic hepatitis delta (CHD) and has ceased active discussions for a global license of the treatment. The company said its decision is based on a recommendation from the Data Safety Monitoring Board (DSMB) to end the trial following a quarterly safety review."The study discontinuation is disappointing, especially for patients with chronic hepatitis delta who have limited treatment options," said David Apelian, who was appointed CEO in June, when Eiger also announced its intention to focus on metabolic diseases with the GLP-1 receptor antagonist avexitide. "We will work closely with the FDA and our investigators to conduct an orderly termination of the LIMT-2 study in the interest of patient safety," he said.Liver decompensationAccording to the company, the DSMB earlier this month advised halting the study after four patients had hepatobiliary events that resulted in liver decompensation. In July, the trial completed enrolment of 158 patients with well-compensated CHD infection. The study randomly assigned 105 patients to peginterferon lambda 180 mcg once weekly for 48 weeks, and 53 patients to no treatment for 12 weeks followed by peginterferon lambda for 48 weeks. All participants were then to receive 24 weeks of follow-up.Strategic pivotApelian stated that "we will continue to execute on our strategic pivot… and seek the financial resources required to advance the company's development activities on avexitide in hyperinsulinaemic hypoglycaemia indications." He added that Eiger continues "to evaluate strategic partnering options for our virology assets."Eiger licensed worldwide rights to peginterferon lambda from Bristol Myers Squibb in 2016. Last year, the FDA rejected Eiger's attempt to get emergency approval for peginterferon lambda as a COVID treatment.

Phase 3Executive Change

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

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External Link

KEGG	Wiki	ATC	Drug Bank
D10078	-	-	DB14767

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Hepatitis C, Chronic	Phase 2	RO	Bristol Myers Squibb Co.	01 Mar 2012
Hepatitis C, Chronic	Phase 2	TR	Bristol Myers Squibb Co.	01 Mar 2012
Hepatitis C, Chronic	Phase 2	IN	Bristol Myers Squibb Co.	01 Mar 2012
Hepatitis C, Chronic	Phase 2	CN	Bristol Myers Squibb Co.	01 Mar 2012
Hepatitis C, Chronic	Preclinical	IE	Bristol Myers Squibb Co.	01 Mar 2012
Hepatitis C, Chronic	Discovery	CN	Bristol Myers Squibb Co.	01 Mar 2012
Hepatitis C, Chronic	Discovery	TR	Bristol Myers Squibb Co.	01 Mar 2012
Hepatitis C, Chronic	Discovery	IN	Bristol Myers Squibb Co.	01 Mar 2012
Hepatitis C, Chronic	Discovery	IE	Bristol Myers Squibb Co.	01 Mar 2012
Hepatitis C, Chronic	Discovery	RO	Bristol Myers Squibb Co.	01 Mar 2012

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Clinical Result

Indication

Phase

Evaluation

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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)	aobgwxvccj(hzafcjxlit) = dgsekanghm dphqnyysso (niozldksgm, hpunlckuck - ueyejockws) View more	-	13 Jun 2023
				Lambda+DCV+Ribavirin (Cohort B: HCV GT-1 or GT-4)	aobgwxvccj(hzafcjxlit) = dsyeyhlscp dphqnyysso (niozldksgm, mcczjtsaqa - gzqjcydkgb) View more
NCT02765802 (LIMT, CTgov)	Phase 2	Hepatitis D, Chronic	33	Peginterferon Lambda-1A (Lambda 180 μg)	ovsgyekbpi(vggnnvcyym) = ncaihuuafu zxtberukpa (eeawjnrrgv, zlyqdkqhni - popoawxgvq) View more	-	17 Jan 2023
				Peginterferon Lambda-1A (Lambda 120 μg)	ovsgyekbpi(vggnnvcyym) = umwgtpcqvh zxtberukpa (eeawjnrrgv, wwziiojlsb - kblxikoxkz) View more
NCT04343976 (CTgov)	Phase 2	COVID-19	14	Pegylated interferon lambda (Lambda Treatment)	ejeayytsmr(uiflntjpyd) = alimxefckh gtgqgkyxbc (cdzhqzppbs, imidacxzwe - jcwdfmgcon) View more	-	21 Jul 2022
				Pegylated interferon lambda (Saline Placebo)	ejeayytsmr(uiflntjpyd) = ochoplzqsw gtgqgkyxbc (cdzhqzppbs, elvnszcrpn - uoztikxksc) View more
NCT04354259 (Pubmed \| Lancet Respir Med) Manual	Phase 2	COVID-19	60	Peginterferon lambda 180 μg	rijvoraorc(dbyljwncdj): 2.42, P-Value = 0.041 View more	Positive	01 May 2021
				Placebo
NCT04331899 (Pubmed \| Nat Commun)	Phase 2	COVID-19	120	Peginterferon Lambda-1a	jeyidzlyjq(eovulckwsx) = obyuxosqly esubxhcqjl (qgrwalwufu ) View more	Negative	30 Mar 2021
				Placebo	jeyidzlyjq(eovulckwsx) = pekykzqrjn esubxhcqjl (qgrwalwufu ) View more
NCT01741545 (MAGNITUDE, CTgov)	Phase 3	Hemophilia \| Hepatitis C, Chronic	71	Lambda+daclatasvir+Ribavirin (Cohort A)	chchhjjaif(gmrumisunf) = ntwkplhnpy srklbpfnbt (mfmhjrkopl, wlmtodskpm - goudwysvuu) View more	-	24 Jun 2019
				Lambda+daclatasvir+Ribavirin (Cohort B)	chchhjjaif(gmrumisunf) = xhebgmaabu srklbpfnbt (mfmhjrkopl, oevdkkifpo - bpyydnshdz) 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))	mmuxeidpzj(ulsbdzrvkd) = vgbpcrdxnm nejosekpqg (rvfmsqmiuu, gsnywlknfg - aqdzofgqzo) View more	-	21 May 2019
				TVR+Peginterferon Lambda-1a+RBV (Part B: Peginterferon Lambda-1a + RBV + TVR)	mjtgrpelmt(firgpfywah) = jeyrlqcusc sojqtuwezt (mjqyotwfyz, rlsbwvjcvg - rbetfujpxo) View more
LIMT HDV study (EASL2019)	Not Applicable	Hepatitis D, Chronic	33	Lambda 120 μg	zsvnmcpgor(mrdxcrbzib) = nrrqoitodv dpqqbitlmj (nktgwgykuv, ±1.4)	-	11 Apr 2019
				Lambda 180 μg	zsvnmcpgor(mrdxcrbzib) = ecqlurjwae dpqqbitlmj (nktgwgykuv, ±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)	(kyuresetgy) = gqaojnjgqo yyqaytidxp (wrqfduxcfb ) View more	Positive	01 Mar 2017
				Ribavirin+Daclatasvir+pegylated interferon-lambda-1a (HCV GT-1(a or b) or -4)	(kyuresetgy) = nmdoexefpr yyqaytidxp (wrqfduxcfb ) View more
NCT01718158 (Pubmed \| J Interferon Cytokine Res) Manual	Phase 3	Hepatitis C, Chronic	440	Peginterferon Lambda-1a+Ribavirin+Daclatasvir	(xfqcvpxqrz) = zlmmgalqus yvvphcilvr (ojvmumgvba )	Superior	01 Nov 2016
				peginterferon alfa-2a+Ribavirin+telaprevir	(xfqcvpxqrz) = ademandmly yvvphcilvr (ojvmumgvba )