Delving into the Latest Updates on Vonapanitase with Synapse

Overview

Basic Info

Drug Type

Enzyme

Synonyms

Recombinant-human-type-I-pancreatic-elastase, Vonapanitase (USAN/INN)

+ [2]

Target-

Mechanism

ECM modulators(Extracellular matrix protein modulators)

Therapeutic Areas

Cardiovascular Diseases

Active Indication

Vascular Diseases

Inactive Indication

Chronic Kidney DiseasesPeripheral arterial occlusive disease

Originator Organization

Proteon Therapeutics, Inc.

Active Organization

Proteon Therapeutics, Inc.Qsv Pharma

Inactive Organization

ArTara Subsidiary, Inc.

Drug Highest PhasePhase 3

First Approval Date-

RegulationOrphan Drug (US)

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Gene Sequence

Sequence Code 1158664

Source: *****

This research study is designed to assess the safety and effectiveness of an experimental drug called vonapanitase (PRT-201) in patients both receiving or expecting to receive hemodialysis who have chronic kidney disease and who are undergoing surgery to create a new access point to their bloodstream for hemodialysis. Vonapanitase is a protein that has been shown in previous research studies to help keep vessels patent when applied to the outside surface of the blood vessels (arteries and veins) in patients who undergo surgery to create an arteriovenous fistula (AVF). The purpose of this study is to determine whether vonapanitase when applied to a limited segment of your blood vessel (about 2 inches) immediately after surgery is safe and improves the patency of your AVF.

Start Date01 Aug 2015

Sponsor / Collaborator

Proteon Therapeutics, Inc.

NCT02110901 / CompletedPhase 3

Multicenter, Double-Blind, Placebo-Controlled Study of PRT-201 Administered Immediately After Radiocephalic Arteriovenous Fistula Creation in Patients With Chronic Kidney Disease

This research study is designed to assess the safety and effectiveness of an experimental drug called PRT-201 in patients both receiving or expecting to receive dialysis who have chronic kidney disease and who are undergoing surgery to create a new access point to their bloodstream for hemodialysis. PRT-201 is a protein that has been shown in previous research studies to help keep vessels patent when applied to the outside surface of the blood vessels (arteries and veins) in patients who undergo surgery to create an arteriovenous fistula (AVF). The purpose of this study is to determine whether PRT-201 when applied to a limited segment of your blood vessel (about 2 inches) immediately after surgery is safe and improves the patency of your AVF.

Start Date01 Jul 2014

Sponsor / Collaborator

Proteon Therapeutics, Inc.

100 Clinical Results associated with Vonapanitase

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100 Translational Medicine associated with Vonapanitase

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100 Patents (Medical) associated with Vonapanitase

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10

Literatures (Medical) associated with Vonapanitase

01 Mar 2022·The Journal of Vascular AccessQ4 · MEDICINE

PATENCY-2 trial of vonapanitase to promote radiocephalic fistula use for hemodialysis and secondary patency

Q4 · MEDICINE

Article

Author: Teruya, Theodore H ; Wilson, Samuel E ; Mishler, Rick E ; Magill, Missy ; Lindow, Francesca ; Peden, Eric K ; Browne, Barry J ; Ferris, Brian L ; Dixon, Bradley S ; Ozaki, Charles Keith ; Gustafson, Pamela ; Settle, Stephen M ; Burke, Steven K ; Wong, Marco D ; Hendon, Kendra S ; Scavo, Vincent A ; Bleyer, Anthony J ; Moist, Louise ; Lucas, John F

Objective: Arteriovenous fistulas created for hemodialysis often fail to become usable and are frequently abandoned. This prospective trial evaluated the efficacy of vonapanitase, a recombinant human elastase, in increasing radiocephalic fistula use for hemodialysis and secondary patency. Methods: PATENCY-2 was a randomized, double-blind, placebo-controlled trial in patients on or approaching the need for hemodialysis undergoing radiocephalic arteriovenous fistula creation. Of 696 screened, 613 were randomized, and 603 were treated (vonapanitase n = 405, placebo n = 208). The study drug solution was applied topically to the artery and vein for 10 min immediately after fistula creation. The primary endpoints were fistula use for hemodialysis and secondary patency (fistula survival without abandonment). Other efficacy endpoints included unassisted fistula use for hemodialysis, primary unassisted patency, fistula maturation and unassisted maturation by ultrasound criteria, and fistula procedure rates. Results: The proportions of patients with fistula use for hemodialysis was similar between groups, 70% vonapanitase and 65% placebo, ( p = 0.33). The Kaplan–Meier estimates of 12-month secondary patency were 78% (95% confidence interval [CI], 73–82) for vonapanitase and 76% (95% CI, 70–82) for placebo ( p = 0.93). The proportions with unassisted fistula use for hemodialysis were 46% vonapanitase and 37% placebo ( p = 0.054). The Kaplan–Meier estimates of 12-month primary unassisted patency were 50% (95% CI, 44–55) for vonapanitase and 43% (95% CI, 35–50) for placebo ( p = 0.18). There were no differences in the proportion of patients with fistula maturation or in fistula procedure rates. Adverse events were similar between groups. Vonapanitase was not immunogenic. Conclusions: Vonapanitase treatment did not achieve clinical or statistical significance to meaningfully improve radiocephalic fistula surgical outcomes. Outcome in the placebo group were better than in historical controls. Vonapanitase was well-tolerated and safe. TRIAL REGISTRATION: clinicaltrials.gov: NCT02414841 ( https://clinicaltrials.gov/ct2/show/NCT02414841 )

01 Feb 2019·Journal of Vascular SurgeryQ2 · MEDICINE

A randomized trial of vonapanitase (PATENCY-1) to promote radiocephalic fistula patency and use for hemodialysis

Q2 · MEDICINE

Article

Author: Peden, Eric K ; Mishler, Rick ; Ozaki, C Keith ; Scavo, Vincent A ; Lee, Timmy ; Browne, Barry J ; Burke, Steven K ; Bleyer, Anthony J ; Kidd, Kendrah ; O'Connor, Timothy P ; Dixon, Bradley S ; Wilson, Samuel E ; Ferris, Brian L

OBJECTIVEArteriovenous fistulas created in patients with chronic kidney disease often lose patency and fail to become usable. This prospective trial evaluated the efficacy of vonapanitase, a recombinant human elastase, in promoting radiocephalic fistula patency and use for hemodialysis.METHODSPATENCY-1 was a double-blind, placebo-controlled trial that enrolled 349 patients on or approaching hemodialysis and being evaluated for radiocephalic arteriovenous fistula creation. Of these, 313 were randomized and 311 treated. Patients were assigned to vonapanitase (n = 210) or placebo (n = 103). The study drug solution was applied topically to the artery and vein for 10 minutes immediately after fistula creation. The primary and secondary end points were primary patency (time to first thrombosis or corrective procedure) and secondary patency (time to abandonment). Tertiary end points included use of the fistula for hemodialysis, fistula maturation by ultrasound, and procedure rates.RESULTSThe Kaplan-Meier estimates of 12-month primary patency were 42% (95% confidence interval [CI], 35-49) and 31% (95% CI, 21-42) for vonapanitase and placebo (P = .25). The Kaplan-Meier estimates of 12-month secondary patency were 74% (95% CI, 68-80) and 61% (95% CI, 51-71) for vonapanitase and placebo (P = .048). The proportions of vonapanitase and placebo patients were 39% and 25% (P = .035) with unassisted use for hemodialysis and 64% and 44% (P = .006) with unassisted plus assisted use.CONCLUSIONSVonapanitase treatment did not significantly improve primary patency but was associated with increased secondary patency and use for hemodialysis. Further research is needed to evaluate these end points.

01 Apr 2017·Journal of Vascular SurgeryQ2 · MEDICINE

Arteriovenous fistula patency in the 3 years following vonapanitase and placebo treatment

Q2 · MEDICINE

Article

Author: Sam, Albert D ; Schanzer, Andres S ; Dixon, Bradley S ; Peden, Eric K ; O'Connor, Timothy P ; Browne, Barry J ; Burke, Steven K ; Jensik, Stephen C

OBJECTIVEThis study explored the long-term outcomes of arteriovenous fistulas treated with vonapanitase (recombinant human elastase) at the time of surgical creation.METHODSThis was a randomized, double-blind, placebo-controlled trial of 151 patients undergoing radiocephalic or brachiocephalic arteriovenous fistula creation who were randomized equally to placebo, vonapanitase 10 μg, or vonapanitase 30 μg. The results after 1 year of follow-up were previously reported. The current analysis occurred when the last patient treated was observed for 3 years. For the current analysis, the primary end point was primary patency; the secondary end points included secondary patency, use of the fistula for hemodialysis, and rate of procedures to restore or to maintain patency.RESULTSThere was no significant difference in the risk of primary patency loss with vonapanitase 10 μg or 30 μg vs placebo. When seven initial patency loss events related to cephalic arch and central vein balloon angioplasty were excluded, the risk of patency loss was reduced with vonapanitase overall (hazard ratio [HR], 0.63; P = .049) and 30 μg (HR, 0.51; P = .03). In patients with radiocephalic fistulas (n = 67), the risks of primary and secondary patency loss were reduced with 30 μg (HR, 0.37 [P = .02] and 0.24 [P = .046], respectively). The rate of procedures to restore or to maintain fistula patency was reduced with 30 μg vs placebo (0.23 vs 0.72 procedure days/patient/year; P = .03) and also reduced in patients with radiocephalic fistulas with 30 μg vs placebo (0.17 vs 0.85 procedure days/patient/year; P = .048).CONCLUSIONSIn this study, vonapanitase did not significantly improve primary patency in the primary analysis but did significantly improve primary patency in an analysis that excluded patency loss due to cephalic arch and central vein balloon angioplasty. In patients with radiocephalic fistulas, 30 μg significantly improved primary and secondary patency. Vonapanitase 30 μg decreased the rate of procedures to restore or to maintain patency in the analysis that included all patients and in the subset with radiocephalic fistulas.

100 Deals associated with Vonapanitase

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External Link

KEGG	Wiki	ATC	Drug Bank
D11770	-	-	DB11690

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Vascular Diseases	Phase 3	-	Qsv Pharma	-
Vascular Diseases	Phase 3	-	Proteon Therapeutics, Inc.	-
Peripheral arterial occlusive disease	Preclinical	US	Proteon Therapeutics, Inc.	01 Oct 2012
Chronic Kidney Diseases	Discovery	US	Proteon Therapeutics, Inc.	01 Jul 2014

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02414841 (PATENCY-2, Pubmed \| J Vasc Access) Manual	Phase 3	-	613	Vonapanitase	dpvlpdhjun(nydjztrskj) = droqextxlm nyyquefupb (drdbltwvni ) View more	Negative	22 Jan 2021
				Placebo	dpvlpdhjun(nydjztrskj) = bebperwkng nyyquefupb (drdbltwvni ) View more
NCT02414841 (PATENCY-2, CTgov)	Phase 3	Chronic Kidney Diseases	696	Vonapanitase (Vonapanitase)	vjkpcupytp(ucovjrwple) = ubzifkdarh pjyyncvycs (kadicwonjl, korgmriuto - mmiitzbjuq) View more	-	13 Aug 2019
				Placebo (Placebo)	vjkpcupytp(ucovjrwple) = zzbctxknkx pjyyncvycs (kadicwonjl, xroqpowcud - wpluimbabp) View more
NCT02110901 (PATENCY-1, CTgov)	Phase 3	Chronic Kidney Diseases	349	Placebo	liukqikdef(ibrvjpjjli) = vwotuwxxhj oivozjnrkg (mwttkywqra, chxvxesgea - iobnrcrasa) View more	-	09 Jul 2019
NCT02110901 (PATENCY-1, Pubmed) Manual	Phase 3	Chronic Kidney Diseases	313	vonapanitase	xhznrnsvjs(chvbwcoyxv) = njeuvacazz jpuqtsthlk (msuzzethps, 35 - 49) View more	Negative	01 Feb 2019
				Placebo	xhznrnsvjs(chvbwcoyxv) = xqasycziqs jpuqtsthlk (msuzzethps, 21 - 42) View more
NCT02110901 (ASN2017)	Phase 3	Chronic Kidney Diseases	311	Vonapanitase	dmyerwqlif(ztklkzgajz) = vkvtsogvda yfpaboouhm (qbchufaaym ) View more	Positive	31 Oct 2017
				Placebo	dmyerwqlif(ztklkzgajz) = fkzjlesdns yfpaboouhm (qbchufaaym ) View more
NCT01305824 (Pubmed \| J Vasc Surg)	Phase 2	Arteriovenous Fistula	151	Placebo	hzwhkywanj(umeamzkuaj) = jvvyfduwoa xzuajygrid (ecpvvcqifo )	Positive	01 Aug 2014
				PRT-201 10 μg	hzwhkywanj(umeamzkuaj) = qtztodirws xzuajygrid (ecpvvcqifo )