Delving into the Latest Updates on EP-9001A with Synapse

Overview

Basic Info

Drug Type

Monoclonal antibody

Synonyms

EP 9001A, EP-9001A, EP9001A

Target

NGF

Action

inhibitors

Mechanism

NGF inhibitors(Nerve growth factor inhibitors)

Therapeutic Areas

Nervous System DiseasesOther Diseases

Active Indication

Cancer Pain

Inactive Indication

Neuralgia

Originator Organization

Chengdu Youluo Biotechnology Co., Ltd.

Active Organization

Chengdu Youluo Biotechnology Co., Ltd.

Inactive Organization

Chengdu Easton Biopharmaceuticals Co., Ltd.

License Organization-

Drug Highest PhasePhase 1/2

First Approval Date-

Regulation-

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主要目的：评价EP-9001A注射液在骨转移癌痛患者中的安全性和耐受性。次要目的： 1)评价EP-9001A注射液在骨转移癌痛患者中的药代动力学特征； 2)评价EP-9001A注射液在骨转移癌痛患者中的免疫原性； 3)评价EP-9001A注射液在骨转移癌痛患者中的初步有效性。

[Translation]

Primary purpose: To evaluate the safety and tolerability of EP-9001A injection in patients with bone metastasis cancer pain. Secondary purposes: 1) To evaluate the pharmacokinetic characteristics of EP-9001A injection in patients with bone metastasis cancer pain; 2) To evaluate the immunogenicity of EP-9001A injection in patients with bone metastasis cancer pain; 3) To evaluate the preliminary efficacy of EP-9001A injection in patients with bone metastasis cancer pain.

Start Date30 Oct 2023

Sponsor / Collaborator

Chengdu Youluo Biotechnology Co., Ltd.

NCT05278611

/ Unknown statusPhase 1

A Randomized, Double-blind, Placebo-controlled Dose Escalation Phase Ia Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of EP-9001A Injection in Healthy Subjects

Nerve Growth Factor（NGF）plays an important role in the pathogenesis of neuropathic pain including cancer pain. EP-9001A is a humanized monoclonal antibody targeting NGF, thus thought to alleviate neuropathic pain though the blockade of NGF signal pathway.
The primary objective of the study is to assess the safety and tolerability of a single dose of subcutaneous (SC) administered EP-9001A in healthy Chinese subjects.

Start Date23 Mar 2022

Sponsor / Collaborator

Chengdu Easton Biopharmaceuticals Co., Ltd.

100 Clinical Results associated with EP-9001A

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100 Translational Medicine associated with EP-9001A

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100 Patents (Medical) associated with EP-9001A

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100 Deals associated with EP-9001A

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Cancer Pain	Phase 2	China	Chengdu Youluo Biotechnology Co., Ltd.	30 Oct 2023
Neuralgia	Phase 1	China	Chengdu Easton Biopharmaceuticals Co., Ltd.	23 Mar 2022

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Clinical Result

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Biosimilar

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