Delving into the Latest Updates on NGGT-001 with Synapse

Overview

Basic Info

Drug Type

AAV based gene therapy

Synonyms

Target

CYP4V2

Mechanism

CYP4V2 modulators(cytochrome P450 family 4 subfamily V member 2 modulators)

Therapeutic Areas

Congenital DisordersEye DiseasesOther Diseases

Active Indication

Retinal DegenerationRetinitis Pigmentosa

Inactive Indication-

Originator Organization

Suzhou Nuojiebei Biotechnology Co., Ltd.

Active Organization

Suzhou Nuojiebei Biotechnology Co., Ltd.

Inactive Organization-

Drug Highest PhasePhase 1/2

First Approval Date-

RegulationOrphan Drug (US)

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主要目的评价NGGT001视网膜下腔注射治疗结晶样视网膜变性的安全性和耐受性，推荐后期临床研究的给药剂量。初步探索NGGT001视网膜下腔注射治疗结晶样视网膜变性的有效性。次要目的评价NGGT001视网膜下腔注射后的药物代谢特性。评价NGGT001视网膜下腔注射后机体的免疫反应。

[Translation]

The primary objective is to evaluate the safety and tolerability of NGGT001 subretinal injection in the treatment of crystalline retinal degeneration and recommend the dosage for later clinical studies. To preliminarily explore the effectiveness of NGGT001 subretinal injection in the treatment of crystalline retinal degeneration. The secondary objective is to evaluate the drug metabolism characteristics of NGGT001 after subretinal injection. To evaluate the body's immune response after subretinal injection of NGGT001.

Start Date21 Mar 2024

Sponsor / Collaborator

Suzhou Nuojiebei Biotechnology Co., Ltd.

NCT06302608 / Active, not recruitingEarly Phase 1IIT

Clinical Trial on the Safety and Effectiveness of Subretinal Injection of NGGT001 for Treating Crystalline Retinal Degeneration

Evaluate the safety and tolerability of NGGT001 subretinal injection for the treatment of crystalline retinal degeneration (BCD)

Start Date08 Feb 2023

Sponsor / Collaborator-

ChiCTR2300067839 / SuspendedPhase 1IIT

A clinical study on the safety and efficacy of subretinal injection of NGGT001 for Bietti crystalline dystrophy

Start Date29 Jan 2023

Sponsor / Collaborator-

100 Clinical Results associated with NGGT-001

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100 Translational Medicine associated with NGGT-001

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100 Patents (Medical) associated with NGGT-001

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100 Deals associated with NGGT-001

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Retinal Degeneration	Phase 2	CN	Suzhou Nuojiebei Biotechnology Co., Ltd.	21 Mar 2024
Retinitis Pigmentosa	IND Approval	US	Suzhou Nuojiebei Biotechnology Co., Ltd.	01 Apr 2023