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

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.

Drug Highest PhasePendingPhase 2

First Approval Date-

Regulation-

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Gene Sequence

Sequence Code 63678

Background: Damaged cartilage can be treated using the creation of microfractures (MFxs) or the porcine-derived collagen-augmented chondrogenesis technique (C-ACT). Purpose: To provide the midterm results of a multicenter randomized controlled trial comparing MFx and C-ACT for knee cartilage defects. Study Design: Randomized controlled trial; Level of evidence, 1. Methods: The study cohort comprised 36 patients with medial femoral condyle cartilage defects who were followed up for 6 years with clinical and magnetic resonance imaging data (n = 14 treated with MFx alone, n = 22 treated with C-ACT). Clinical outcomes were assessed preoperatively and at 1, 2, and 6 years postoperatively using a visual analog scale (VAS) for pain, the Knee injury and Osteoarthritis Outcome Score (KOOS), and the International Knee Documentation Committee (IKDC) subjective score. Magnetic resonance imaging scans were performed preoperatively and at 1 and 6 years postoperatively, and the repaired cartilage tissue was evaluated using the magnetic resonance observation of cartilage repair tissue (MOCART) score. The repaired tissue/reference cartilage ratio was quantified using T2 mapping. Adverse events during follow-up were also evaluated. Results: In both groups, the VAS pain score improved and was maintained for 1, 2, and 6 years postoperatively compared with preoperatively ( P < .05 for all). Although there were no significant differences between groups in the VAS pain, KOOS, or IKDC scores at any time point, the change in the IKDC—Activities of Daily Living subscore from preoperatively to 6 years postoperatively was better in the C-ACT group than the MFx group ( P = .0423). At 6 years postoperatively, the MOCART assessment showed superior results regarding the surface of the repair tissue in the C-ACT group compared with the MFx group ( P = .0288). There were no differences between the groups in the total MOCART score or other subscores. Conclusion: The study results suggest that C-ACT has similar effects to MFx in improving pain, joint function, and imaging findings and may be superior to MFx in improving daily life function and improving the quality of the surface of the cartilage tissue. Registration: ClinicalTrials.gov identifier: NCT02539030.

01 Jun 2020·Arthroscopy: The Journal of Arthroscopic & Related SurgeryQ1 · MEDICINE

Microfractures Versus a Porcine-Derived Collagen-Augmented Chondrogenesis Technique for Treating Knee Cartilage Defects: A Multicenter Randomized Controlled Trial

Q1 · MEDICINE

Article

Author: Chang, Chong Bum ; Wang, Joon Ho ; Song, In Soo ; Yoo, Jae Doo ; Chon, Je-Gyun ; Choi, Nam Yong ; Chun, Churl Hong ; Kang, Seung-Baik ; Kim, Jin Goo ; Ha, Jeong Ku ; In, Yong ; Kim, Myung Ku ; Kim, Man Soo ; Moon, Chan Woong

PURPOSEThe purpose of this study was to evaluate the clinical efficacy and safety of treating patients with a cartilage defect of the knee with microfractures and porcine-derived collagen-augmented chondrogenesis technique (C-ACT).METHODSOne hundred participants were randomly assigned to the control group (n = 48, microfracture) or the investigational group (n = 52, C-ACT). Clinical and magnetic resonance imaging (MRI) outcomes were assessed 12 and 24 months postoperatively for efficacy and adverse events. Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) assessment was used to analyze cartilage tissue repair. MRI outcomes for 50% defect filling and repaired tissue/reference cartilage (RT/RC) ratio were quantified using T2 mapping. Clinical outcomes were assessed using the visual analogue scale (VAS) for pain and 20% improvement, minimal clinically important difference (MCID), and patient acceptable symptom state for Knee Injury and Osteoarthritis Outcome Score (KOOS) and the International Knee Documentation Committee score.RESULTSMOCART scores in the investigation group showed improved defect repair and filling (P = .0201), integration with the border zone (P = .0062), and effusion (P = .0079). MRI outcomes showed that the odds ratio (OR) for ≥50% defect filling at 12 months was statistically higher in the investigation group (OR 3.984, P = .0377). Moreover, the likelihood of the RT/RC OR becoming ≥1 was significantly higher (OR 11.37, P = .0126) in the investigation group. At 24 months postoperatively, the OR for the VAS 20% improvement rate was significantly higher in the investigational group (OR 2.808, P = .047). Twenty-three patients (52.3%) in the control group and 35 (77.8%) in the investigation group demonstrated more than the MCID of KOOS pain from baseline to 1 year postoperatively, with a significant difference between groups (P = .0116).CONCLUSIONIn this multicenter randomized trial, the addition of C-ACT resulted in better filling of cartilage defect of the knee joint.LEVEL OF EVIDENCELevel Ⅰ, Multicenter Randomized Controlled Trial.

01 Apr 2016·Diabetes CareQ1 · MEDICINE

Long-Acting C-Peptide and Neuropathy in Type 1 Diabetes: A 12-Month Clinical Trial

Q1 · MEDICINE

Article

Author: Foyt, Howard ; Wahren, John ; Arezzo, Joseph C. ; Daniels, Mark

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.

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	CA	Cebix, Inc.	01 Oct 2012
Diabetes Mellitus, Type 1	Phase 2	US	Cebix, Inc.	01 Oct 2012
Diabetes Mellitus, Type 1	Phase 2	SE	Cebix, Inc.	01 Oct 2012
Diabetic peripheral neuropathy	Phase 2	US	Cebix, Inc.	01 Oct 2012
Diabetic peripheral neuropathy	Phase 2	SE	Cebix, Inc.	01 Oct 2012
Diabetic peripheral neuropathy	Phase 2	CA	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	Diabetes Mellitus, Type 1	250	Long-acting C-peptide 0.8 mg	lvskyldeij(nijkpyqafd) = nuqmrtvkeq dncedqvuco (dseeqmychb ) View more	-	01 Apr 2016
				Long-acting C-peptide 2.4 mg	lvskyldeij(nijkpyqafd) = lghbdrtwjm dncedqvuco (dseeqmychb ) View more