Delving into the Latest Updates on Blisibimod with Synapse

Overview

Basic Info

Drug Type

Peptibody

Synonyms

Blisibimod (USAN/INN), A-623, AMG-623

Target

BAFF

Action

inhibitors

Mechanism

BAFF inhibitors(B-cell-activating factor/B lymphocyte stimulator inhibitors)

Therapeutic Areas

Immune System DiseasesSkin and Musculoskeletal DiseasesUrogenital Diseases+ [5]

Active Indication-

Inactive Indication

Glomerulonephritis, IGAGranulomatosis With PolyangiitisMicroscopic Polyangiitis+ [3]

Originator Organization

Amgen, Inc.

Active Organization-

Inactive Organization

Anthera Pharmaceuticals, Inc.

Amgen, Inc.

License Organization

Zenyaku Kogyo Co., Ltd.

Amgen, Inc.

Anthera Pharmaceuticals, Inc.

Drug Highest PhaseDiscontinuedPhase 3

First Approval Date-

RegulationOrphan Drug (United States)

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Structure/Sequence

Sequence Code 1191632873

Source: *****

The purpose of this study is to evaluate the clinical efficacy of blisibimod as measured by a composite responder index in subjects who, despite corticosteroid use, continue to have seropositive, clinically-active Systemic Lupus Erythematosus (SLE) as defined by SELENA-SLEDAI score ≥10, and positive for anti-double stranded DNA and low complement (C3 or C4).

Start Date01 Jun 2016

Sponsor / Collaborator

Anthera Pharmaceuticals, Inc.

NCT02074020

/ WithdrawnPhase 3

A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study to Evaluate the Efficacy and Safety of Blisibimod Administration in Subjects With Systemic Lupus Erythematosus With or Without Nephritis

The purpose of this study is to evaluate the clinical efficacy of blisibimod as measured by a composite responder index in subjects who, despite corticosteroid use, continue to have autoantibody positive, clinically-active Systemic Lupus Erythematosus (SLE) as defined by SELENA SLEDAI score ≥10.

Start Date01 Dec 2015

Sponsor / Collaborator

Anthera Pharmaceuticals, Inc.

NCT01609452

/ WithdrawnPhase 2/3

MONICA-SC: A Randomized, Double-Blind, Placebo-Controlled Phase 2/3 Study to Evaluate the Efficacy, Safety and Tolerability of Blisibimod (A-623) Administration in Subjects With Immune Thrombocytopenic Purpura (ITP)

The purpose of this study is to evaluate efficacy, safety and tolerability of blisibimod when administered on top of standard-of-care to subjects with Immune Thrombocytopenic Purpura (ITP).

Start Date01 Dec 2015

Sponsor / Collaborator

Anthera Pharmaceuticals, Inc.

100 Clinical Results associated with Blisibimod

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100 Translational Medicine associated with Blisibimod

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100 Patents (Medical) associated with Blisibimod

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20

Literatures (Medical) associated with Blisibimod

01 Dec 2023·Clinical rheumatology

A narrative review of potential drug treatments for nephritis in children with IgA vasculitis (HSP)

Review

Author: Lamond, Megan ; Chetwynd, Andrew J ; Marro, Julien ; Oni, Louise ; Williams, Chloe E C

Abstract:

Immunoglobulin A (IgA) vasculitis (IgAV, also known as Henoch-Schoenlein purpura, HSP) is the most common vasculitis of childhood. It usually presents with a simple, self-limiting disease course; however, a small subset of patients may develop kidney involvement (IgAV-N) which occurs 4–12 weeks after disease onset and is the biggest contributor to long-term morbidity. Treatment currently targets patients with established kidney involvement; however; there is a desire to work towards early prevention of inflammation during the window of opportunity between disease presentation and onset of significant nephritis. There are no clinical trials evaluating drugs which may prevent or halt the progression of nephritis in children with IgAV apart from the early use of corticosteroids which have no benefit. This article summarises the latest scientific evidence and clinical trials that support potential therapeutic targets for IgAV-N that are currently being developed based on the evolving understanding of the pathophysiology of IgAV-N. These span the mucosal immunity, B-cell and T-cell modulation, RAAS inhibition, and regulation of complement pathways, amongst others. Novel drugs that may be considered for use in early nephritis include TRF-budesonide; B-cell inhibiting agents including belimumab, telitacicept, blisibimod, VIS649, and BION-1301; B-cell depleting agents such as rituximab, ofatumumab, and bortezomib; sparsentan; angiotensin converting enzyme inhibitors (ACE-Is); and complement pathway inhibitors including avacopan, iptacopan, and narsoplimab. Further clinical trials, as well as pre-clinical scientific studies, are needed to identify mechanistic pathways as there may be an opportunity to prevent nephritis in this condition.Key Points• Kidney involvement is the main cause of long-term morbidity and mortality in IgA vasculitis despite the current treatment recommendations.• The evolving understanding of the pathophysiology of IgA vasculitis is allowing exploration of novel treatment options which target underlying immune pathways.• Novel treatments currently being trialled in IgA nephropathy may have benefit in IgA vasculitis due to the similarities in the underlying pathophysiology, such as TRF-budesonide, B-cell modulators, and complement inhibitors.• Further studies, including clinical trials of novel drugs, are urgently needed to improve the long-term outcomes for children with IgA vasculitis nephritis.

01 Jul 2021·Annals of the rheumatic diseases

Correspondence to ‘Time to change the primary outcome of lupus trials’

Letter

Author: Oon, Shereen ; Nikpour, Mandana ; Huq, Molla

We note with interest and express our principle agreement with the views put forward by Professor Frederic Houssiau in the recent Editorial ‘Time to change the primary outcome of lupus trials’ published in Annals of the Rheumatic Diseases .1 Professor Houssiau advocated using steroid reduction as a primary outcome measure in systemic lupus erythematosus (SLE) clinical trials, or as a minimum, incorporating a steroid reduction target into the primary endpoint. This proposal was prompted by the observation that, like many other recent phase 3 clinical trials conducted with drugs that have a sound biological mechanism for benefit in SLE, the recently published CHABLIS-SC phase 3 clinical trial of subcutaneous blisibimod in SLE2 failed to meet its primary endpoint of a week 52-SLE Responder Index (SRI)-6. However, a significant steroid sparing effect was seen, with a modified endpoint of a week 52-SRI-6 combined with a reduction in steroid dose during weeks 40–52 compared with study entry, showing a trend to benefit for the blisibimod …

01 Jan 2019·Therapeutic advances in musculoskeletal diseaseQ3 · MEDICINE

Biological therapies and their clinical impact in the treatment of systemic lupus erythematosus

Q3 · MEDICINE

Review

Author: Magro, Rosalie

The development of biological therapies has had an impact on the management of several medical conditions. Their use in systemic lupus erythematosus (SLE), however, remains very limited. This review has summarized the evidence on the clinical effect of biologicals in SLE. Biological drugs with a number of targets have been studied in several phase II and III randomized controlled trials (RCTs). Positive results have been obtained in phase III RCTs with belimumab and this led to its license for active SLE. The clinical experience with belimumab has confirmed the efficacy and safety of belimumab in SLE. Promising results have been noted in phase II trials for blisibimod, sifalimumab, anifrolumab, and ustekinumab. Despite the fact that the RCTs with rituximab did not achieve their primary endpoint, clinical experience with rituximab is extensive and shows favorable clinical response in refractory renal and non-renal SLE. It is hoped that further ongoing phase III RCTs on a number of biological agents in SLE will highlight the potential role of other biologicals in the management of this challenging and heterogeneous condition.

5

News (Medical) associated with Blisibimod

28 Dec 2016

·www.biospace.com

Anthera Pharma Plunges After Cystic Fibrosis Drug Fails Late-Stage Trial

December 28, 2016 By Mark Terry , BioSpace.com Breaking News Staff Hayward, Calif. – Anthera Pharmaceuticals announced that its Sollpura to treat cystic fibrosis patients with exocrine pancreatic insufficiency (EPI) failed to meet its primary endpoint in a Phase III study. The company emphasized that it only narrowly missed the primary endpoint, which was non-inferiority for change in the Coefficient of Fat Absorption (CFA). And that the drug did meet the non-inferiority criterion. It also confirmed that the ratio of the three enzymes in the drug showed an appropriate response in the coefficient of nitrogen absorption (CNA). Anthera indicated that during its analysis, the patients were unable to increase their doses because of time restrictions and the protocol design. In addition, other patients couldn’t increase their dose to the daily limit for porcine pancreatic enzyme replacement therapies (PERTs). As a result, and because of faith in the analyzed Sollpura activity data, the company will launch an additional trial of the drug that it believes will optimize dosing and dose titration. It’s expected to start in the first quarter of 2017 and will result in “only a modest delay in the filing of the BLA” around the first quarter of 2018. Anthera took a dive at the news. Shares traded for $1.99 on December 27 and are currently trading for $0.72. The company faced another setback in November when it announced the CHABLIS-SC1 clinical trial with blisibimod to treat systemic lupus erythematosus (SLE) didn’t meet its primary endpoint. And shortly afterwards, the company shook up its leadership team. J. Crag Thompson stepped in as chief executive officer, replacing Paul Truex . Truex took over as chairman of the board, replacing Christopher Henney , who is remaining on the company’s board of directors. The company at the time indicated that Thompson’s promotion was in preparation for the commercial launch of Sollpura and the continued development of blisibimod for IgA nephropathy. Of Sollpura, John Carroll , writing for Endpoints News, said, “This is a drug with multiple failures to contend with. Eli Lilly tried the pancreatic enzyme replacement therapy liprotomase in a Phase III and failed in 2011. Anthera acquired the drug in 2014. It is designed to treat low digestive enzyme levels, or Exocrine Pancreatic Insufficiency, caused by CF.” Investors weren’t terribly happy in November when blisibimod failed its clinical trial, and the recent plunge indicated they’re even less happy about the results of the Sollpura trial. And in quoting from an optimistic investors’ note by Jefferies ’ Matthew Andrews written several weeks ago, Carroll speculates on whether the backlash will be even worse. Andrews wrote, “We believe the Phase III study has a high likelihood of success based on its non-inferiority design, a well-controlled patient population enrolled in the study (potential for less variability in efficacy), improved formulation (higher lipase dose), and weight-based dosing (vs. fixed dosing in the prior Lilly-sponsored Phase III study). The study has successfully passed two safety reviews by the data monitoring board.” It’s possible, of course, that the additional trial will solve the problem, although if it doesn’t, the company is going to have some explaining to do. “Although we are disappointed to narrowly miss the primary endpoint, we remain encouraged by the overall SOLUTION study results and look forward to releasing final data from its 12-week extension phase in the future, the SIMPLICITY study and the continuation of the open-label EASY study,” said William Shanahan , Anthera’s chief medical officer, in a statement. “We would like to thank the patients, investigators and study staff for their hard work and dedication to our study. We are most grateful for their commitment to our shared hope of developing new treatments for exocrine pancreatic insufficiency, and believe that the shortcomings of Sollpura in SOLUTION can be addressed in the new study that we plan to initiate in 1Q’17.”

Phase 3Executive ChangePhase 2

07 Dec 2016

·www.biospace.com

Bay Area’s Anthera Names a New CEO in Shakeup

December 7, 2016 By Alex Keown , BioSpace.com Breaking News Staff HAYWARD, Calif. – Shares of Anthera Pharmaceuticals are up more than 48 percent this morning after the company announced changes in leadership as it moves closer to commercializing its cystic fibrosis drug, Sollpura. On Tuesday, the Bay Area-based company announced it promoted announced J. Craig Thompson to Chief Executive Officer. He takes over for Paul Truex , who will now assume the responsibilities of the Chairman of the Board and continue to provide guidance to Anthera’s senior executive team. After 10 years as chairman, Christopher Henney is stepping down from that role, but will remain on the company’s board of directors. In a statement Tuesday, Truex said Thompson’s promotion will prepare the company for the commercialization of Sollpura and the continued development of blisibimod for IgA nephropathy. Thompson joined the company at the beginning of 2016. Truex said over the course of the year Thompson “has proven his ability to lead and to fully integrate his experiences into the operation of Anthera.” Prior to Anthera, Thompson served as chief operating officer for Tetraphase Pharmaceuticals where he oversaw the development and implementation of the marketing, sales strategy, business development and the commercial manufacturing for Tetraphase. Before Tetraphase, Thompson served as chief commercial officer for Trius Therapeutics until the company was acquired by Cubist Pharmaceuticals, Inc. in September 2013. Thompson said he looks forward to executing the company’s strategy to “commercialize Sollpura while further exploring opportunities for blisibimod.” “This is an exciting time for Anthera with new data emerging on both Sollpura and blisibimod, which could transform the company’s future,” Thompson said in a statement. Sollpura is an enzyme replacement therapy being developed for cystic fibrosis patients who suffer from exocrine pancreatic insufficiency. The drug is designed for patients who are either unable to swallow multiple pills or are forced to use gastric tubes in order to maintain appropriate nutritional health, according to the company’s website. The company expects to announce Phase III results before the end of the year, or in early 2017. Anthera is preparing to begin a Phase III clinical trial for Sollpura in toddlers. In a separate announcement on Tuesday, Anthera also reported positive trends from its Phase II proof-of-concept study blisibimod for IgA nephropathy. Blisibimod is a selective peptibody antagonist of the B-cell activating factor (BAFF) cytokine. In its announcement, Anthera said patients taking the drug through 48 weeks demonstrated “stable to slightly decreasing levels of estimated 24 hour urinary protein excretion… as compared to slowly increasing levels of proteinuria in the placebo group.” No safety or tolerability concerns were observed with blisibimod during routine reviews, the company added. Development of blisibimod suffered a small setback earlier this year when Anthera’s Japanese development partner, Zenyaku , ended a two-year-old collaboration agreement. Shares of Anthera are trading at $2.17 as of 10:50 a.m. The stock closed at $1.47 on Tuesday, Dec. 6.

Phase 2Executive ChangeClinical ResultPhase 3Acquisition

15 Sep 2015

·www.biospace.com

Anthera Shares Slump as Zenyaku Kogyo Backs Out of Blisibimod Deal

September 15, 2015 By Mark Terry , BioSpace.com Breaking News Staff Hayward, Calif.-based Anthera Pharmaceuticals, Inc. announced today that its Japanese development partner, Zenyaku , had ended a December 2014 Collaboration and License Agreement. The deal will terminate Jan. 7, 2016. The original deal was for the development of blisibimod in Japan. Blisibimod is a selective peptibody antagonist of the B-cell activating factor (BAFF) cytokine. It was originally developed to treat lupus and IgA nephropathy. BAFF is vital to the development, maintenance and survival of B-cells, a type of immune cell. The drug appears to inhibit BAFF, which in turn seems to regulate B-cell activity, which is involved in certain types of autoimmune disorders. “Progress of blisibimod in Japan, particularly for IgA nephropathy, has been disappointing,” said Paul Truex , president and chief executive officer of Anthera in a statement. “ Zenyaku ’s termination of the License Agreement will provide flexibility for us to pursue a potentially optimized development path for blisibimod in IgA nephropathy and facilitate discussions with alternative partners in Asia at the appropriate time. As a result of our financing efforts over the past twelve months, including Zenyaku ’s substantial equity investments and cost reimbursements, we remain well funded to advance the development of blisibimod and Sollpura.” In the original deal , Anthera kept full development and commercialization rights for global territories including North America and the European Union, outside Asia. As part of that deal, Zenyaku was to pay up to $26 million over an 18-month period through a combination of a forgivable loan and multiple equity purchases of Anthera common stock priced to a 33 percent premium over the volume weighted average stock price at the time. Zenyaku was also to reimburse Anthera for some of the clinical trial expenses. An additional $22 million was to be paid out for various milestones. Amgen originally developed blisibimod. As part of that deal, Amgen was also eligible for some milestone payments in the Asian markets if the drug was commercialized. At Anthera ’s 2015 second quarter financial reporting in August, the company reported a net loss for the quarter of $8.9 million and for the six-month period, $16.6 million, improvements over the same periods in 2014. The company reported that its drug, Sollpura (liprotamase), for cystic fibrosis patients who suffer from exocrine pancreatic insufficiency, was about to start a Phase III clinical trial. It has also started planning another clinical study with a powder formulation of the drug in infants and toddlers. The company also received a $1.1 million research award in June 2015 from the Cystic Fibrosis Foundation Therapeutics, Inc. Anthera is also currently enrolling patients in the Phase III CHABLIS-SC1 clinical study of blisibimod for systemic lupus erythematosis (SLE). The funding in part comes from a July public offering. is rather volatile at the moment. Shares traded on June 19 for $9.21, dropped on July 9 to $7.47, rose on July 27 to $11.15. Shares dropped again to $7.01 on Aug. 25, rose to $8.18 on Sept. 10 and are currently trading for $7.63. “Regaining full worldwide control of blisibimod development, and in particular the IgA nephropathy program, is exciting as we are now free to consider additional approaches including the potential examination of the clinical data from the BRIGHT-SC study at an earlier time point than originally planned,” said Colin Hislop , Anthera ’s chief medical officer in a statement. “The BRIGHT-SC study remains fully blinded and will continue as planned with all currently enrolled patients continuing to follow the protocol.”

License out/inPhase 3Financial Statement

100 Deals associated with Blisibimod

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External Link

KEGG	Wiki	ATC	Drug Bank
D10311	Blisibimod	-	DB12330

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Nephritis	Phase 3	United States	Anthera Pharmaceuticals, Inc.	01 Jun 2016
Purpura, Thrombocytopenic, Idiopathic	Phase 3	-	Anthera Pharmaceuticals, Inc.	01 Dec 2015
Glomerulonephritis, IGA	Phase 3	Germany	Anthera Pharmaceuticals, Inc.	01 Jun 2013
Glomerulonephritis, IGA	Phase 3	South Korea	Anthera Pharmaceuticals, Inc.	01 Jun 2013
Glomerulonephritis, IGA	Phase 3	United Kingdom	Anthera Pharmaceuticals, Inc.	01 Jun 2013
Systemic Lupus Erythematosus	Phase 3	United States	Anthera Pharmaceuticals, Inc.	01 Feb 2013
Systemic Lupus Erythematosus	Phase 3	Belarus	Anthera Pharmaceuticals, Inc.	01 Feb 2013
Systemic Lupus Erythematosus	Phase 3	Brazil	Anthera Pharmaceuticals, Inc.	01 Feb 2013
Systemic Lupus Erythematosus	Phase 3	Colombia	Anthera Pharmaceuticals, Inc.	01 Feb 2013
Systemic Lupus Erythematosus	Phase 3	Guatemala	Anthera Pharmaceuticals, Inc.	01 Feb 2013

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT01395745 (CHABLIS-SC1, Pubmed) Manual	Phase 3	Systemic Lupus Erythematosus	442	blisibimod	gjrvkcfkxp(dquptohyfu) = The SRI-6 primary end point was not met yhmjldftvk (gfpislznxr ) View more	Negative	01 Jun 2018
				Placebo
NCT01395745 (CHABLIS-SC1, EULAR2017)	Phase 3	Systemic Lupus Erythematosus anti-nuclear antibodies \| anti-dsDNA \| complement C3	442	Blisibimod 200 mg	lielzookkk(kqkjrhnsen) = xgqgjcjoxy wbjxdozdsw (sgowrguxch ) View more	Negative	14 Jun 2017
				Placebo	lielzookkk(kqkjrhnsen) = rnqvmzzjaq wbjxdozdsw (sgowrguxch ) View more
NCT01395745 (CHABLIS-SC1, EULAR2016)	Phase 3	Systemic Lupus Erythematosus anti-double-stranded DNA (dsDNA) \| low complement C3 or C4	442	Blisibimod	gwihlsfube(nbeojfzmra) = dexgnykkub auzorwkbqi (akdlabvvfb ) View more	Positive	08 Jun 2016
NCT02411136 \| NCT02443506 (Pubmed \| Arthritis Res Ther)	Phase 1	Systemic Lupus Erythematosus BAFF	-	Blisibimod	yewowjryyr(koyhipmpcz) = With time, memory B cells reverted to baseline, leading to a calculated 30 % reduction in total B cells by approximately 160 days after the first dose teedwhqogl (txlefmkypj )	-	01 Dec 2015
NCT01162681 (PEARL-SC, Pubmed \| Arthritis Rheumatol \| Ann Rheum Dis) Manual	Phase 2	Systemic Lupus Erythematosus	547	blisibimod	qiayboisfw(ukaocempft) = SRI-5 response rates were not significantly improved in the pooled blisibimod groups furifsdhyh (ltvkkfzqtr )	Positive	01 Sep 2015
				Placebo
NCT01162681 (PEARL-SC, EULAR2015)	Phase 2	Systemic Lupus Erythematosus anti-double-stranded DNA \| anti-nuclear antibodies	547	Blisibimod 200 mg QW	znfrjdlasg(pwugayfpot) = sdgbdrdvce vsjiuhtuza (omxsrottfg ) View more	Positive	10 Jun 2015
				Placebo	znfrjdlasg(pwugayfpot) = gxwqgzaaua vsjiuhtuza (omxsrottfg ) View more
PEARL-SC and OLE (EULAR2014)	Phase 2	Systemic Lupus Erythematosus proteinuria \| renal biomarkers \| inflammation biomarkers ... View more	547	Blisibimod 200 mg monthly SC	hvczvybggc(ifortnhkhd) = Blisibimod was safe and well-tolerated at all dose levels with no meaningful imbalances in serious adverse events or infections between blisibimod and placebo in the PEARL-SC study, and continued to be well-tolerated through the OLE study. kmgyfxfums (frtjpkoknc ) View more	-	11 Jun 2014
				Blisibimod 100 mg weekly SC
ACR2013	Not Applicable	Systemic Lupus Erythematosus	-	Blisibimod	lhemweifje(mxkvdwvcsy) = no meaningful imbalances in serious adverse events or infections between blisibimod and placebo in the PEARL-SC study, and continued to be well-tolerated through the OLE study arbdamumin (byebudcyhp ) View more	-	25 Oct 2013
				Placebo
NCT01162681 (PEARL-SC, ACR2013)	Phase 2	Systemic Lupus Erythematosus anti-double-stranded DNA \| anti-nuclear antibodies	547	Blisibimod 100 mg QW	dorozztqzb(jhewrahzau) = During the placebo-controlled study, critically low IgG levels (<4g/L) were observed in 1/280 subjects in blisibimod group compared with 0/266 subjects on placebo cgtcnzkfwf (tqgnsgdjey ) View more	Positive	25 Oct 2013
				Blisibimod 200 mg QW
Phase 2b (EULAR2013)	Phase 2	Systemic Lupus Erythematosus proteinuria \| inflammation \| anti-dsDNA antibodies ... View more	547	Blisibimod	sqkrnunxxm(nvuwkfkmpa) = gqtzzaabms vbqzbtkuwq (iwykcptgco, -35.0%)	Positive	12 Jun 2013
				Placebo	sqkrnunxxm(nvuwkfkmpa) = xfgsvbyhqp vbqzbtkuwq (iwykcptgco, -5.1%)

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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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Blisibimod

Overview

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Core Patent

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