Delving into the Latest Updates on TV-1106 with Synapse

Overview

Basic Info

Drug Type

Hormone

Synonyms

Albumin/somatropin fusion protein, Albusomatropin, Albutropin

+ [1]

Target

GHR

Action

agonists

Mechanism

GHR agonists(Growth hormone receptor agonists)

Therapeutic Areas

Nervous System DiseasesCongenital DisordersEndocrinology and Metabolic Disease+ [2]

Active Indication-

Inactive Indication

Dwarfism, PituitaryGrowth hormone deficiency

Originator Organization

Teva Pharmaceutical Industries Ltd.

Active Organization-

Inactive Organization

Teva Pharmaceutical Industries Ltd.

Drug Highest PhaseDiscontinuedPhase 3

First Approval Date-

Regulation-

Login to view timeline

Structure/Sequence

Sequence Code 9616461

Source: *****

AbstractSome biologics can modulate cytokines that may lead to changes in expression of drug‐metabolizing enzymes and cause drug‐drug interactions (DDI). DDI potential of TV‐1106—an albumin‐fused growth hormone (GH)—was investigated. In this study, human blood was exposed to recombinant human growth hormone (rhGH) or TV‐1106, followed by isolation of the plasma and its application to human hepatocytes. While the treatment of blood with rhGH increased multiple cytokines, treatment of blood with TV‐1106 had no effect on any of the nine cytokines tested. The interleukin (IL)‐6 concentration was higher in the rhGH then in the TV‐1106‐treated plasma (P < .05). While rhGH had little or no effect on CYP1A2 or CYP2C19 mRNA but increased CYP3A4 mRNA twofold, TV‐1106 had little or no effect on cytochrome P450 (CYP) mRNAs in hepatocytes. Although the plasma from rhGH‐treated blood lowered CYP1A2 activity, the TV‐1106 plasma had no effect on CYP activities. The CYP1A2 activity was lower in the rhGH‐ then in the TV‐1106‐plasma treated hepatocytes (P < .05). The results indicated that fusing GH with albumin made TV‐1106 an unlikely participant of CYP1A2, CYP2C19 or CYP3A4‐facilitated, direct or cytokine‐driven DDI.

01 Oct 2016·Growth Hormone & IGF ResearchQ3 · MEDICINE

Safety and PK/PD correlation of TV-1106, a recombinant fused human albumin-growth hormone, following repeat dose administration to monkeys

Q3 · MEDICINE

Article

Author: Rosenstock, Moti ; Ashkenazi, Nurit ; Bassan, Merav ; Rasamoelisolo, Michele ; Leuschner, Jost ; Hallak, Hussein ; Shinar, Doron

PURPOSETV-1106 is a recombinant human albumin genetically fused to growth hormone which is intended to reduce the frequency of injections for GH therapy users. We report the safety, tolerability, pharmacokinetics and pharmacodynamics of repeated subcutaneous injections of TV-1106 in Cynomolgus monkeys.METHODCynomolgus monkeys received four weekly subcutaneous injections of 0, 5, 10 or 20mg/kg TV-1106 and were monitored for safety signals throughout the study. Serum levels of TV-1106 and insulin-like growth factor 1 (IGF-1) were assayed.RESULTSTreated animals showed no adverse effects or histopathological changes. TV-1106 serum concentrations showed sustained exposure to the drug. Exposure increased in a dose-dependent manner with peak concentrations at approximately 24h post-dosing and elimination half-lives in the range of 12 to 24h. IGF-1 serum concentrations were elevated throughout the entire study duration, indicative of the pharmacological response. There was a clear correlation between change in IGF-1 levels and dose or exposure to TV-1106.CONCLUSIONSThe safety, pharmacokinetic and pharmacodynamic findings support the further development of TV-1106 as a once-weekly administered treatment for patients with GHD.

01 Nov 2015·European Journal of EndocrinologyQ1 · MEDICINE

Safety, pharmacokinetic and pharmacodynamic properties of TV-1106, a long-acting GH treatment for GH deficiency

Q1 · MEDICINE

Article

Author: Sakov, Anat ; Bassan, Merav ; Spiegelstein, Ofer ; Brown, Kurt ; Cohen-Barak, Orit ; Rasamoelisolo, Michele ; Mendzelevski, Boaz

BackgroundTV-1106 (Teva Pharmaceuticals) is a genetically fused recombinant protein of human GH (hGH) and human serum albumin, in development for treatment of GH deficiency (GHD). TV-1106 is expected to have an extended duration of action compared to daily GH treatment and may enable a reduction in the frequency of injections and improve compliance and quality of life for adults and children requiring GHD therapy.ObjectiveTo assess the safety, local tolerability, pharmacokinetics and pharmacodynamics of TV-1106 following single s.c. injections in healthy male volunteers.MethodsSubjects (n=56) were assigned to one of seven ascending dose groups (3–100 mg) and received either a single dose of TV-1106 (n=6) or placebo (n=2) by s.c. injection.ResultsEighteen subjects reported 43 adverse effects (AEs), which were mild to moderate; no serious AEs (SAEs) occurred. In 50, 70 and 100 mg groups there were mild to moderate increases in heart rate and systolic blood pressure that significantly correlated with higher levels of IGF1. TV-1106 showed pharmacokinetic characteristics of a long-acting hGH as demonstrated by a terminal elimination half-life of 23–35 h, delayed time of peak concentration, and systemic levels seen up to 7 days after dosing. IGF1 levels increased in a dose-dependent manner, before reaching a plateau, with levels above baseline extending beyond 7 days post dose.ConclusionSingle administration of TV-1106 up to 100 mg was safe in healthy volunteers. Pharmacokinetics and pharmacodynamics support once-weekly administration in patients with GHD.

100 Deals associated with TV-1106

Login to view more data

External Link

KEGG	Wiki	ATC	Drug Bank
-	-	-	DB12950

R&D Status

10 top R&D records.

Login

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Dwarfism, Pituitary	Phase 3	Bulgaria	Teva Pharmaceutical Industries Ltd.	01 Apr 2015
Dwarfism, Pituitary	Phase 3	Greece	Teva Pharmaceutical Industries Ltd.	01 Apr 2015
Dwarfism, Pituitary	Phase 3	Greece	Teva Pharmaceutical Industries Ltd.	01 Apr 2015
Dwarfism, Pituitary	Phase 3	Ukraine	Teva Pharmaceutical Industries Ltd.	01 Apr 2015
Dwarfism, Pituitary	Phase 3	Ukraine	Teva Pharmaceutical Industries Ltd.	01 Apr 2015
Dwarfism, Pituitary	Phase 3	Italy	Teva Pharmaceutical Industries Ltd.	01 Apr 2015
Dwarfism, Pituitary	Phase 3	Italy	Teva Pharmaceutical Industries Ltd.	01 Apr 2015
Growth hormone deficiency	Phase 3	Hungary	Teva Pharmaceutical Industries Ltd.	-
Growth hormone deficiency	Phase 3	Austria	Teva Pharmaceutical Industries Ltd.	-
Growth hormone deficiency	Phase 3	United States	Teva Pharmaceutical Industries Ltd.	-

Login to view more data

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02410343 (CTgov)	Phase 3	Growth hormone deficiency	14	Placebo (Placebo)	fnminmcdns(aawitshmev) = ekkupnvqwn csvfatjlih (vbbtvzuwfh, qefafttidk - oajbkkfayc) View more	-	11 Jun 2018
				TV-1106 (TV-1106)	fnminmcdns(aawitshmev) = xkrfosxsig csvfatjlih (vbbtvzuwfh, qeusuxizmc - bhubvrnmsq) View more

Login to view more data

Translational Medicine

Boost your research with our translational medicine data.

login

or

view full example data

Boost your research with our translational medicine data.

Deal

Boost your decision using our deal data.

login

or

view full example data

Boost your decision using our deal data.

Core Patent

Boost your research with our Core Patent data.

login

or

view full example data

Boost your research with our Core Patent data.

Clinical Trial

Identify the latest clinical trials across global registries.

login

or

view full example data

Identify the latest clinical trials across global registries.

Approval

Accelerate your research with the latest regulatory approval information.

login

or

view full example data

Accelerate your research with the latest regulatory approval information.

Biosimilar

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.

login

or

view full example data

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.

Regulation

Understand key drug designations in just a few clicks with Synapse.

login

or

view full example data

Understand key drug designations in just a few clicks with Synapse.

TV-1106

Overview

Basic Info

Structure/Sequence

Related

External Link

R&D Status

Clinical Result

Translational Medicine

Deal

Core Patent

Clinical Trial

Approval

Biosimilar

Regulation