Delving into the Latest Updates on Pegylated synthetic human c-peptide with Synapse

Overview

Basic Info

Drug Type

Synthetic peptide

Synonyms

C-peptide long-acting, Ersatta, PEGylated C-peptide

+ [3]

Target

C-peptide x NGF

Action

modulators, stimulants

Mechanism

C-peptide modulators(Connecting peptide modulators), NGF stimulants(Nerve growth factor stimulants), Adenosine triphosphatase stimulants

Therapeutic Areas

Immune System DiseasesNervous System DiseasesEndocrinology and Metabolic Disease

Active Indication-

Inactive Indication

Diabetes Mellitus, Type 1Diabetic peripheral neuropathy

Originator Organization

Cebix, Inc.

Active Organization-

Inactive Organization

Cebix, Inc.

License Organization-

Drug Highest PhasePendingPhase 2

First Approval Date-

Regulation-

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Structure/Sequence

Sequence Code 63678

Source: *****

OBJECTIVELack of C-peptide in type 1 diabetes may be an important contributing factor in the development of microvascular complications. Replacement of native C-peptide has been shown to exert a beneficial influence on peripheral nerve function in type 1 diabetes. The aim of this study was to evaluate the efficacy and safety of a long-acting C-peptide in subjects with type 1 diabetes and mild to moderate peripheral neuropathy.RESEARCH DESIGN AND METHODSA total of 250 patients with type 1 diabetes and peripheral neuropathy received long-acting (pegylated) C-peptide in weekly dosages of 0.8 mg (n = 71) or 2.4 mg (n = 73) or placebo (n = 106) for 52 weeks. Bilateral sural nerve conduction velocity (SNCV) and vibration perception threshold (VPT) on the great toe were measured on two occasions at baseline, at 26 weeks, and at 52 weeks. The modified Toronto Clinical Neuropathy Score (mTCNS) was used to grade the peripheral neuropathy.RESULTSPlasma C-peptide rose during the study to 1.8–2.2 nmol/L (low dose) and to 5.6–6.8 nmol/L (high dose). After 52 weeks, SNCV had increased by 1.0 ± 0.24 m/s (P < 0.001 within group) in patients receiving C-peptide (combined groups), but the corresponding value for the placebo group was 1.2 ± 0.29 m/s. Compared with basal, VPT had improved by 25% after 52 weeks of C-peptide therapy (Δ for combined C-peptide groups: −4.5 ± 1.0 μm, placebo group: −0.1 ± 0.9 μm; P < 0.001). mTCNS was unchanged during the study.CONCLUSIONSOnce-weekly subcutaneous administration of long-acting C-peptide for 52 weeks did not improve SNCV, other electrophysiological variables, or mTCNS but resulted in marked improvement of VPT compared with placebo.

01 Jul 2015·International Journal of ToxicologyQ4 · MEDICINE

A 9-Month Toxicity and Toxicokinetic Assessment of Subcutaneous Pegylated Human C-peptide (CBX129801) in Cynomolgus Monkeys

Q4 · MEDICINE

Article

Author: Kousba, Ahmed ; Naas, Dennis ; Morris, Teresa ; Mazzoni, Michelle

C-peptide is formed in the biosynthesis of insulin and is therefore deficient in patients with type 1 diabetes mellitus. A pegylated form of human synthetic C-peptide (CBX129801) has been developed to extend the half-life of the native peptide and is undergoing clinical investigation as replacement therapy to treat diabetic peripheral neuropathy. This monkey study was conducted to evaluate the toxicity of CBX129801 with weekly subcutaneous dosing for 39 weeks at dose levels of 0 (vehicle), 0.4, 1.33, and 4.0 mg/kg/wk. No systemic adverse effects were observed at any dose with maximal CBX129801 plasma concentrations of 735 to 1050 nmol/L during the dosing period (physiological range is 1-3 nmol/L). CBX129801-related effects were limited to minimal macrophagic vacuolization at the injection sites and in the associated draining (axillary) lymph nodes; these local effects largely resolved by the end of a 7-week recovery period. No systemic macrophagic vacuolization was observed. Additionally, there was no histological evidence for plaque formation in the major arteries of these nondiabetic animals.

100 Deals associated with Pegylated synthetic human c-peptide

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External Link

KEGG	Wiki	ATC	Drug Bank
-	-	-	DB16283

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Diabetes Mellitus, Type 1	Phase 2	Sweden	Cebix, Inc.	01 Oct 2012
Diabetes Mellitus, Type 1	Phase 2	Canada	Cebix, Inc.	01 Oct 2012
Diabetes Mellitus, Type 1	Phase 2	United States	Cebix, Inc.	01 Oct 2012
Diabetic peripheral neuropathy	Phase 2	Canada	Cebix, Inc.	01 Oct 2012
Diabetic peripheral neuropathy	Phase 2	United States	Cebix, Inc.	01 Oct 2012
Diabetic peripheral neuropathy	Phase 2	Sweden	Cebix, Inc.	01 Oct 2012

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT01681290 (Pubmed \| Diabetes Care)	Phase 2	Diabetic Neuropathies	250	Long-acting C-peptide 0.8 mg	vceupcshpb(eexfuomewp) = lthqazeqhc hydcfsjera (oruliwdniq ) View more	-	01 Apr 2016
				Long-acting C-peptide 2.4 mg	vceupcshpb(eexfuomewp) = firxbwbkwl hydcfsjera (oruliwdniq ) View more

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Biosimilar

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