Delving into the Latest Updates on Pegpleranib Sodium with Synapse

Overview

Basic Info

Drug Type

Aptamers

Synonyms

Fovista, Pegpleranib, DD50D2QKH1 (UNII code)

+ [7]

Target

PDGF

Action

inhibitors

Mechanism

PDGF inhibitors(Platelet-derived growth factor inhibitors)

Therapeutic Areas

Congenital DisordersEye DiseasesCardiovascular Diseases+ [3]

Active Indication-

Inactive Indication

Choroidal NeovascularizationDystrophy, MacularFibrosis+ [4]

Originator Organization

Archemix Corp.

Active Organization-

Inactive Organization

Ophthotech Corp. (New Jersey)

IVERIC bio, Inc.

National Eye Institute

License Organization

Oldtech, Inc.

Novartis AG

IVERIC bio, Inc.

Drug Highest PhaseDiscontinuedPhase 3

First Approval Date-

Regulation-

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Structure/Sequence

Sequence Code 239098577

Source: *****

Background: People with Von-Hippel-Lindau (VHL) disease may experience significant vision loss as a result of retinal capillary hemangiomas (RCH), the most common and often earliest manifestation of VHL.
Objective: To investigate the safety and possible efficacy of combination investigational treatment with serial intravitreal injections of E10030, a PDGF-B antagonist, and ranibizumab, a VEGF-A antagonist, in participants with severe ocular VHL disease.
Design: Three participants with severe ocular VHL disease will receive the combination investigational treatment in one eye and will be followed for 104 weeks.
Primary Outcome: The safety of the combination investigational treatment, assessed by tabulation of adverse events reported through Week 52.

Start Date23 Jan 2017

Sponsor / Collaborator

National Eye Institute

EUCTR2015-000518-23-CZ

/ TerminatedPhase 2

A phase 2b randomized, double-masked, controlled trial to establish the safety and efficacy of intravitreous administration of Fovista® (Anti-PDGFBB pegylated aptamer) administered in combination with Avastin® compared to Avastin® monotherapy in subjects with subfoveal neovascular age-related macular degeneration.

Start Date31 Aug 2016

Sponsor / Collaborator

Ophthotech Corp. (New Jersey)

NCT02387957

/ TerminatedPhase 2

A 24 Month Phase 2a Open Label, Randomized Study of Avastin®, Lucentis®, or Eylea® (Anti-VEGF Therapy) Administered in Combination With Fovista® (Anti-PDGF BB Pegylated Aptamer)

To evaluate the safety of intravitreal (IVT) Fovista® administered in combination with anti-VEGF therapy.

Start Date26 Apr 2016

Sponsor / Collaborator

Ophthotech Corp. (New Jersey)

100 Clinical Results associated with Pegpleranib Sodium

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100 Translational Medicine associated with Pegpleranib Sodium

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100 Patents (Medical) associated with Pegpleranib Sodium

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6

Literatures (Medical) associated with Pegpleranib Sodium

03 Jul 2017·Expert opinion on emerging drugsQ2 · MEDICINE

Emerging vascular endothelial growth factor antagonists to treat neovascular age-related macular degeneration

Q2 · MEDICINE

Review

Author: Hussain, Rehan M ; Ciulla, Thomas A.

INTRODUCTION:

Evolving anti-vascular endothelial growth factor (VEGF) treatments for neovascular age-related macular degeneration (nAMD) include long acting agents, combination strategies involving new pathways, topical agents, sustained-release, and genetic therapy strategies. Areas covered: Brolucizumab and abicipar pegol have smaller molecular size, facilitating higher concentrations and potentially longer duration than current anti-VEGF agents. Agents being combined with anti-VEGFs include OPT-302 (to inhibit VEGF-C and VEGF-D); pegpleranib and rinucumab (to inhibit platelet derived growth factor, PDGF - but both failed to show consistently improved visual outcomes compared to anti-VEGF monotherapy); and RG7716, ARP-1536 and nesvacumab (to activate the Tie-2 tyrosine kinase receptor, which reduces permeability). X-82 is an oral anti-VEGF and anti-PDGF being tested in phase 2 studies. Topical anti-VEGF ± anti-PDGF drugs under study include pazopanib, PAN-90806, squalamine lactate, regorafinib, and LHA510. Sustained-release anti-VEGF delivery treatments, such as the ranibizumab Port Delivery System, GB-102, NT-503, hydrogel depot, Durasert, and ENV1305 aim to reduce the burden of frequent injections. Gene therapies with new viral vectors hold the potential to induce sustained expression of anti-angiogenic proteins via the retina's cellular apparatus, and include AVA-101/201, ADVM-202/302, AAV2-sFLT01, RGX314, and Retinostat. Expert opinion: There are many emerging anti-VEGF treatments that aim to improve visual outcomes and reduce the treatment burden of nAMD.

01 Feb 2017·OphthalmologyQ1 · MEDICINE

Dual Antagonism of PDGF and VEGF in Neovascular Age-Related Macular Degeneration

Q1 · MEDICINE

Article

Author: Eandi, Chiara M ; Jaffe, Glenn J ; Ciardella, Antonio P ; Ciulla, Thomas A ; Westby, Keith ; Masonson, Harvey ; Patel, Samir C ; Monés, Jordi ; Pearlman, Joel A ; Dugel, Pravin U ; Quaranta-El Maftouhi, Maddalena ; Devin, Francois ; Ricci, Federico

PURPOSE:

To assess the safety and efficacy of E10030 (Fovista; Ophthotech, New York, NY), a platelet-derived growth factor (PDGF) antagonist, administered in combination with the anti-vascular endothelial growth factor (VEGF) agent ranibizumab (Lucentis; Roche, Basel, Switzerland) compared with ranibizumab monotherapy in patients with neovascular age-related macular degeneration (nAMD).

DESIGN:

Phase IIb global, multicenter, randomized, prospective, double-masked, controlled superiority trial.

PARTICIPANTS:

Four hundred forty-nine patients with treatment-naïve nAMD.

METHODS:

Participants were randomized in a 1:1:1 ratio to 1 of the following 3 intravitreal treatment groups: E10030 0.3 mg in combination with ranibizumab 0.5 mg, E10030 1.5 mg in combination with ranibizumab 0.5 mg, and sham in combination with ranibizumab 0.5 mg (anti-VEGF monotherapy). Drugs were administered monthly in each of the groups for a total duration of 24 weeks.

MAIN OUTCOME MEASURES:

The prespecified primary end point was the mean change in visual acuity (VA; Early Treatment Diabetic Retinopathy [ETDRS] letters) from baseline to 24 weeks.

RESULTS:

No significant safety issues were observed in any treatment group. The E10030 (1.5 mg) combination therapy regimen met the prespecified primary end point of superiority in mean VA gain compared with anti-VEGF monotherapy (10.6 compared with 6.5 ETDRS letters at week 24; P = 0.019). A dose-response relationship was evident at each measured time point commencing at 4 weeks. Visual acuity outcomes favored the E10030 1.5 mg combination therapy group regardless of baseline VA, lesion size, or central subfield thickness on optical coherence tomography. All clinically relevant treatment end points of visual benefit (≥15 ETDRS letter gain, final VA ≥20/40 or ≥20/25) and visual loss (≥1 ETDRS line loss, ≥2 ETDRS line loss, final VA ≤20/125 or ≤20/200) favored the E10030 1.5 mg combination group.

CONCLUSIONS:

In this phase IIb clinical trial, a 62% relative benefit from baseline was noted in the E10030 1.5 mg combination therapy group compared with the anti-VEGF monotherapy group. A favorable safety and efficacy profile of E10030 combination therapy for nAMD was evident across multiple clinically relevant end points. This highly powered study provides strong rationale for a confirmatory phase III clinical trial.

01 Feb 2017·Ophthalmic surgery, lasers & imaging retinaQ4 · MEDICINE

An Overview of the Fovista and Rinucumab Trials and the Fate of Anti-PDGF Medications

Q4 · MEDICINE

Review

Author: Dunn, Evan N. ; Sheth, Veeral S. ; Hariprasad, Seenu M.

SLACK Incorporated’s journal copyright agreements enable authors funded by the National Institutes of Health (NIH) to deposit their accepted manuscripts to PubMed Central for posting 12 months following publication by SLACK Incorporated. The agreement also allows posting of accepted manuscripts on authors’ institutional repositories, with the exception of open access repositories, 12 months following publication by SLACK Incorporated. Authors should include a link to the final published article on the journal website. SLACK Incorporated will retain copyright for these articles, which prohibits republication elsewhere, and SLACK Incorporated will retain the right to charge a fee for the final published versions of these articles in whatever format they appear.

5

News (Medical) associated with Pegpleranib Sodium

01 May 2023

·www.fiercebiotech.com

Astellas keeps the big buyouts rolling, inking $5.9B Iveric takeover ahead of FDA eye disease ruling

Astellas framed the deal to buy Iveric Bio as a way to further its focus on blindness and regeneration. The multibillion-dollar biotech buyouts keep on coming. Astellas Pharma is the latest drugmaker to get in on the act, agreeing to pay $5.9 billion to buy Iveric Bio and establish itself as a player in an emerging eye disease niche. Iveric is less than three months away from learning whether the FDA will approve avacincaptad pegol, a complement C5 protein inhibitor that reduced the rate of geographic atrophy (GA) progression in a phase 3 clinical trial. Patients with GA, a cause of irreversible loss of vision in patients with age-related macular degeneration (AMD), lacked treatments until recently, but the market is heating up fast. Apellis Pharmaceuticals won the first FDA approval for a GA drug, Syfovre, in February, and companies including AstraZeneca, Johnson & Johnson, Novartis and Roche are in pursuit. Iveric, a biotech formerly known as Ophthotech, is poised to be the first commercial rival to Apellis, though. That fact has caught Astellas’ attention. Astellas has agreed to pay $40 per share in cash to buy Iveric. The fee represents a 22% premium over Iveric’s closing price at the end of last week. That may seem light in the wake of the triple-digit premiums that GSK and Sanofi have paid recently for Bellus Health and Provention Bio, respectively, but it follows a steady rise in Iveric’s share price. The premium over Iveric’s March 31 share price is 64%. The willingness of Astellas to pay $5.9 billion for Iveric reflects the Japanese drugmaker’s desire to hit its 2025 sales target and need to add new growth drivers to offset the anticipated loss of revenue when the prostate cancer drug Xtandi loses patent protection in 2027. Astellas also framed the deal as a way to further its focus on blindness and regeneration. Cell and gene therapies are part of the strategy, but that side of the pipeline has stuttered, with enrollment in a phase 1 trial of GA candidate ASP7317 stopping for two years and a glaucoma prospect acquired in the Quethera buyout yet to reach the clinic. Buying Iveric will give Astellas a GA drug that could be approved by the time the deal closes in the third quarter and accelerate an expansion into ophthalmology by providing control of the commercial team and other infrastructure that the biotech has built up to support the launch. Earlier this year, Iveric said it was building a 120-person sales team that would include 50 to 70 field-based reps. The deal completes an impressive recovery for Iveric, which was on the ropes in 2017. Back then, a run of three clinical trial failures for Fovista sunk the biotech’s stock and wiped out the optimism generated when Novartis paid $200 million for ex-U.S. rights to the AMD asset. Yet, Iveric recovered, changing its name from Ophthotech and embarking on a GA strategy that culminates today in the Astellas buyout.

AcquisitionPhase 1Phase 3Drug Approval

05 Apr 2021

·www.biospace.com

Iveric Bio’s Co-Founder Leaves to Return to Venture Capitalist Role

IVERIC bio’s co-founder and Executive Chairman David R. Guyer is stepping down from his role to return to his first love – investing. He’ll make a return to his former role at SV Health Investors as a Venture Partner. In it from day one, Guyer has guided the company from the boardroom since the retinal disease company’s 2007 inception. Then named Ophthotech, Guyer also led as CEO from 2013-2017. Iveric has been through some highs and lows in Guyer’s time. After a somewhat promising Phase II combination trial, the company’s wet age-related macular degeneration (AMD) drug Fovista flopped badly in Phase III, failing to show any measurable benefit. Guyer had to make the tough call to cut 80% of staff, leaving its headcount at less than 50. From there, the company pivoted toward gene therapies, in-licensing a portfolio of eye disease-related treatments in development. This move led to the renaming of the Ophthotech to Iveric Bio, updating its Nasdaq symbol to the clever “ISEE” on the ticker. Iveric’s lead drug Zimura is a C5 inhibitor currently in development for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD). Zimura published positive Phase III results last fall and continues in a Phase II study for autosomal recessive Stargardt disease. “I am very excited about Iveric's phase 3 program of Zimura for the treatment of geographic atrophy secondary to age-related macular degeneration and look forward to continuing to serve the company as a senior advisor,” Guyer said. Guyer will remain a senior advisor to Iveric, without the weight of any executive powers. “As a co-founder, former Chief Executive Officer and most recently Executive Chair, David has been an integral part of Iveric Bio’s leadership, a trusted advisor and visionary in retinal medicine, and I sincerely thank him for his hard work and significant contributions to the Company,” stated Glenn P. Sblendorio, chief executive officer and president of Iveric Bio. “Iveric Bio's strong management team has evolved to the point where there is no longer a need for an Executive Chair,” Guyer added. “After more than 14 years on the Board, I feel that this is a good departure point such that I can return to my passion as a venture capitalist."

02 Mar 2017

·www.bioportfolio.com

Ophthotech Corp OPHT Pharmaceuticals Healthcare Deals and Alliances Profile Prices from USD $250

Summary Ophthotech Corp Ophthotech is a biopharmaceutical company that provides developing therapeutics for agerelated macular degeneration. The company's products include Fovista, an antiplateletderived growth factor PDGF, Zimura an anticomplemente is a central component of the complement cascade that is supposed to be involved in the development of AMD. Ophthotech utilizes aptamer technology, a single strands of nucleic acid to targets such as PDGF, comparable to a monoclonal antibody. The company's Fovista is used to inhibit abnormal new blood vessel growth associated with wet AMD. Ophthotech is headquartered in New York, the US. Ophthotech Corp OPHT Pharmaceuticals Healthcare Deals and Alliances Profile provides you comprehensive data and trend analysis of the company's Mergers and Acquisitions MAs, partnerships and financings. The report provides detailed information on Mergers and Acquisitions, Equity/Debt Offerings, Private Equity, Venture Financing and Partnership transactions recorded by the company over a five year period. The report offers detailed comparative data on the number of deals and their value categorized into deal types, subsector and regions. GlobalData derived the data presented in this report from proprietary inhouse Pharma eTrack deals database, and primary and secondary research. Scope Financial Deals Analysis of the company's financial deals including Mergers and Acquisitions, Equity/Debt Offerings, Private Equity, Venture Financing and Partnerships. Deals by Year Chart and table displaying information encompassing the number of deals and value reported by the company by year, for a five year period. Deals by Type Chart and table depicting information including the number of deals and value reported by the company by type such as Mergers and Acquisitions, Equity/Debt Offering etc. Deals by Region Chart and table presenting information on the number of deals and value reported by the company by region, which includes North America, Europe, Asia Pacific, the Middle East and Africa and South and Central America. Deals by Subsector Chart and table showing information on the number of deals and value reported by the company, by subsector. Major Deals Information on the company's major financial deals. Each such deal has a brief summary, deal type, deal rationale; and deal financials and target Company's major public companies key financial metrics and ratios. Business Description A brief description of the company's operations. Key Employees A list of the key executives of the company. Important Locations and Subsidiaries A list and contact details of key centers of operation and subsidiaries of the company. Key Competitors A list of the key competitors of the company. Key Recent Developments A brief on recent news about the company. Reasons to Buy Get detailed information on the company's financial deals that enable you to understand the company's expansion/divestiture and fund requirements The profile enables you to analyze the company's financial deals by region, by year, by business segments and by type, for a five year period. Understand the company's business segments' expansion / divestiture strategy The profile presents deals from the company's core business segments' perspective to help you understand its corporate strategy. Access elaborate information on the company's recent financial deals that enable you to understand the key deals which have shaped the company Detailed information on major recent deals includes a summary of each deal, deal type, deal rationale, deal financials and Target Company's key financial metrics and ratios. Equip yourself with detailed information about the company's operations to identify potential customers and suppliers. The profile analyzes the company's business structure, locations and subsidiaries, key executives and key competitors. Stay uptodate on the major developments affecting the company Recent developments concerning the company presented in the profile help you track important events. Gain key insights into the company for academic or business research Key elements such as break up of deals into categories and information on detailed major deals are incorporated into the profile to assist your academic or business research needs. Note*: Some sections may be missing if data is unavailable for the company.

AntibodyAcquisition

100 Deals associated with Pegpleranib Sodium

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Dystrophy, Macular	Phase 3	Belgium	IVERIC bio, Inc.	01 Aug 2013
Dystrophy, Macular	Phase 3	Denmark	IVERIC bio, Inc.	01 Aug 2013
Dystrophy, Macular	Phase 3	Switzerland	IVERIC bio, Inc.	01 Aug 2013
Dystrophy, Macular	Phase 3	Turkey	IVERIC bio, Inc.	01 Aug 2013
Dystrophy, Macular	Phase 3	United Kingdom	IVERIC bio, Inc.	01 Aug 2013
Wet age-related macular degeneration	Phase 3	United States	Ophthotech Corp. (New Jersey)	01 Aug 2013
Wet age-related macular degeneration	Phase 3	Argentina	Ophthotech Corp. (New Jersey)	01 Aug 2013
Wet age-related macular degeneration	Phase 3	Australia	Ophthotech Corp. (New Jersey)	01 Aug 2013
Wet age-related macular degeneration	Phase 3	Austria	Ophthotech Corp. (New Jersey)	01 Aug 2013
Wet age-related macular degeneration	Phase 3	Belgium	Ophthotech Corp. (New Jersey)	01 Aug 2013

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02859441 (Pubmed \| Clin Exp Ophthalmol) Manual	Phase 1/2	Von Hippel-Lindau Disease	3	E10030+ranibizumab	dbhsvltcmb(bqmrzrpaqo) = One participant manifested mild episodic ocular hypertension in the study eye ocbyclokmm (kfvgnntfzd ) View more	Negative	21 Sep 2021
NCT01940887 (OPH1004, CTgov)	Phase 3	Wet age-related macular degeneration	645	aflibercept+E10030+bevacizumab (E10030 + Bevacizumab or Aflibercept)	logyqlojqy(plksdtaqry) = qhebiodeyj xyaasnhcbs (tgtpmylhxc, 0.85) View more	-	30 Sep 2020
				aflibercept+E10030 sham injection+bevacizumab (Sham + Bevacizumab or Aflibercept)	logyqlojqy(plksdtaqry) = mzyfepehtb xyaasnhcbs (tgtpmylhxc, 0.85) View more
NCT02214628 (CTgov)	Phase 2	Wet age-related macular degeneration	101	Fovista (Fovista® (Anti-PDGF BB) Plus Anti-VEGF Simultaneous Regimen)	xfjkpcoiht = ajqluhucyc czzaqwgodt (cphqekxskd, nbmbuqxvzr - pizuyaxrbc) View more	-	10 Jul 2019
				Fovista (Fovista® (Anti-PDGF BB) Plus Anti-VEGF Pre-Treatment Regimen)	xfjkpcoiht = bgpgejagnu czzaqwgodt (cphqekxskd, aotmedkxad - eocholgwgo) View more
NCT02387957 (CTgov)	Phase 2	Age Related Macular Degeneration	63	Fovista®+bevacizumab (Fovista® Plus Bevacizumab)	snopojofjw = wumthbhmlc tjguplqynk (lyedvljyjl, huhqcpkmqt - xbjbkegvtv) View more	-	05 Mar 2019
				ranibizumab+Fovista® (Fovista® Plus Ranibizumab)	snopojofjw = herlfgarub tjguplqynk (lyedvljyjl, jdwwmczrog - yfrwgelnla) View more
NCT01940900 (OPH1003, CTgov)	Phase 3	Wet age-related macular degeneration	627	ranibizumab+E10030 (E10030 + Ranibizumab)	ibtxjkyadv(ejrtcgpowu) = zfgmxonccz rbhkvwscpl (xcrohuvhsm, 0.88) View more	-	15 Aug 2018
				ranibizumab+E10030 sham intravitreal injection (Sham + Ranibizumab)	ibtxjkyadv(ejrtcgpowu) = zlenwnxzkq rbhkvwscpl (xcrohuvhsm, 0.87) View more
NCT01944839 (OPH1002, CTgov)	Phase 3	Wet age-related macular degeneration	619	ranibizumab+E10030 (E10030 + Ranibizumab)	xzazkrvxjb(tnvlwdcjve) = dbtqytxnvj wozbnfcutn (oraqkstffo, 0.86) View more	-	10 Aug 2018
				ranibizumab+E10030 sham intravitreal injection (Sham + Ranibizumab)	xzazkrvxjb(tnvlwdcjve) = vbtyohqtgd wozbnfcutn (oraqkstffo, 0.86) View more
NCT01940887 (OPH1004, PipelineReview) Manual	Phase 3	Wet age-related macular degeneration	640	Aflibercept+Avastin+Fovista	ehtqsnskkt(fzhotowbqi) = dotsqhsfaw fpqsoreast (gmjcrvopna )	Negative	15 Aug 2017
				Aflibercept+Avastin+Placebo	ehtqsnskkt(fzhotowbqi) = vizrxpgdem fpqsoreast (gmjcrvopna )
NCT01940900 (OPH1003, PipelineReview) Manual	Phase 3	Wet age-related macular degeneration	627	Ranibizumab+Pegpleranib Sodium	djodhvtiot(ovlohakchh) = npesplymzj anetypzfxl (nlswrgsthl )	Negative	12 Dec 2016
				Ranibizumab+Placebo	djodhvtiot(ovlohakchh) = orjtgyrfbu anetypzfxl (nlswrgsthl )
NCT01944839 (OPH1002, PipelineReview) Manual	Phase 3	Wet age-related macular degeneration	621	Ranibizumab+Pegpleranib Sodium	lrgzzdwdgy(ekgyuqnprm) = pgaomskbof boumvksyrs (eanwjogszq )	Negative	12 Dec 2016
				Ranibizumab+Placebo	lrgzzdwdgy(ekgyuqnprm) = pyazyhavbo boumvksyrs (eanwjogszq )
ARVO2016	Phase 2	Blindness PDGF \| VEGF	449	Fovista 0.3mg + ranibizumab 0.5mg	ykkcrrutbd(wzqyatxljw) = xkwpwphnub racjsprvvd (fsfkhuadad )	Positive	01 May 2016
				Fovista 1.5mg + ranibizumab 0.5mg	ykkcrrutbd(wzqyatxljw) = pjrcrigqmm racjsprvvd (fsfkhuadad )