[Translation] A Phase II, double-blind, placebo-controlled, randomized withdrawal study to evaluate the safety and efficacy of XG005 in subjects with cancer-induced bone pain (CIBP)

评估XG005与安慰剂相比在癌性骨痛中的镇痛效果。评估XG005在癌性骨痛受试者中的安全性。评估XG005对生活质量（QoL）测量结果的影响。

[Translation]

To evaluate the analgesic efficacy of XG005 compared to placebo in cancer bone pain. To evaluate the safety of XG005 in subjects with cancer bone pain. To evaluate the effect of XG005 on quality of life (QoL) measures.

Start Date25 Dec 2023

Sponsor / Collaborator

Xgene Pharmaceutical, Inc.

NCT06017999 / RecruitingPhase 2/3

A Randomized, Double-Blind, Placebo Controlled Trial to Evaluate the Safety and Efficacy of XG005 Tablets in Subjects Undergoing Bunionectomy

This study will evaluate the safety, efficacy, and PK of low dose (750 mg) and high-dose (1250 mg) XG005 oral tablets compared with placebo in subjects undergoing bunionectomy. Subjects will be confined in the clinic from check-in through 72 hours post-surgery to monitor subject safety.

Start Date08 Aug 2023

Sponsor / Collaborator

Xgene Pharmaceutical, Inc.

CTR20222406 / RecruitingPhase 2

一项在疼痛性膝骨关节炎受试者中评价XG005的安全性和疗效的IIb期、随机、双盲、安慰剂对照和平行组研究

[Translation] A Phase IIb, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the safety and efficacy of XG005 in subjects with painful knee osteoarthritis

评估两种剂量水平的XG005与安慰剂相比的镇痛效果评估XG005在疼痛性膝骨关节炎（OA）受试者中的安全性评估XG005对膝关节功能和生活质量（QoL）测量指标的影响评估XG005的药代动力学

[Translation]

To evaluate the analgesic efficacy of two dose levels of XG005 compared to placebo To evaluate the safety of XG005 in subjects with painful knee osteoarthritis (OA) To evaluate the effects of XG005 on knee function and quality of life (QoL) measures To evaluate the pharmacokinetics of XG005

Start Date28 Nov 2022

Sponsor / Collaborator

Xgene Pharmaceutical, Inc.

100 Clinical Results associated with Pregabalin naproxencarbil

100 Translational Medicine associated with Pregabalin naproxencarbil

100 Patents (Medical) associated with Pregabalin naproxencarbil

Literatures (Medical) associated with Pregabalin naproxencarbil

01 May 2023·Cell Reports

Fortuitous somatic mutations during antibody evolution endow broad neutralization against SARS-CoV-2 Omicron variants

Article

Author: Gao, Yidan ; He, Jiaying ; Wang, Jiarong ; Chiang, Bing-Yu ; Wang, Zegen ; Sun, Lei ; Wu, Jianbo ; Wang, Qiao ; Xia, Anqi ; Jiang, Weiyu ; Chen, Zhenguo ; Zhan, Wuqiang ; Hao, Aihua ; Zhou, Yunjiao ; Zhang, Lunan ; Xie, Minxiang ; Wang, Bin ; Zhang, Xiang ; Wu, Fan ; Han, Yuru ; Xue, Song ; Mayer, Christian T.

Striking antibody evasion by emerging circulating severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) variants drives the identification of broadly neutralizing antibodies (bNAbs).However, how a bNAb acquires increased neutralization breadth during antibody evolution is still elusive.Here, we identify a clonally related antibody family from a convalescent individual.One of the members, XG005, exhibits potent and broad neutralizing activities against SARS-CoV-2 variants, while the other members show significant reductions in neutralization breadth and potency, especially against the Omicron sublineages.Structural anal. visualizing the XG005-Omicron spike binding interface reveals how crucial somatic mutations endow XG005 with greater neutralization potency and breadth.A single administration of XG005 with extended half-life, reduced antibody-dependent enhancement (ADE) effect, and increased antibody product quality exhibits a high therapeutic efficacy in BA.2- and BA.5-challenged mice.Our results provide a natural example to show the importance of somatic hypermutation during antibody evolution for SARS-CoV-2 neutralization breadth and potency.

Fortuitous Somatic Mutations during Antibody Evolution Endow Broad Neutralization against SARS-CoV-2 Omicron Variants

Author: Zhou, Yunjiao ; He, Jiaying ; Wu, Jianbo ; Wu, Fan ; Wang, Jiarong ; Chen, Zhenguo ; Sun, Lei ; Han, Yuru ; Wang, Qiao ; Xia, Anqi ; Jiang, Weiyu ; Mayer, Christian T ; Hao, Aihua ; Zhan, Wuqiang ; Zhang, Lunan ; Wang, Zegen ; Zhang, Xiang ; Gao, Yidan ; Wang, Bin ; Xie, Minxiang ; Xue, Song ; Chiang, Bing-Yu

ABSTRACTStriking antibody evasion by emerging circulating SARS-CoV-2 variants drives the identification of broadly neutralizing antibodies (bNAbs). However, how a bNAb acquires increased neutralization breadth during antibody evolution is still elusive. Here, we identified a clonally-related antibody family from a convalescent individual. One of the members, XG005, exhibited potent and broad neutralizing activities against SARS-CoV-2 variants, while the other members showed significant reductions in neutralization breadth and potency, especially against the Omicron sublineages. Structural analysis visualizing the XG005-Omicron spike binding interface revealed how crucial somatic mutations endowed XG005 with greater neutralization potency and breadth. A single administration of XG005 with extended half-life, reduced antibody-dependent enhancement (ADE) effect, and increased antibody product quality, exhibited a high therapeutic efficacy in BA.2- and BA.5-challenged mice. Our results provided a natural example to show the importance of somatic hypermutation during antibody evolution for SARS-CoV-2 neutralization breadth and potency.

100 Deals associated with Pregabalin naproxencarbil

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Acute Pain	Phase 3	US	Xgene Pharmaceutical, Inc.	08 Aug 2023
Cancer Pain	Phase 2	TW	Xgene Pharmaceutical, Inc.	25 Dec 2023
Cancer Pain	Phase 2	CN	Xgene Pharmaceutical, Inc.	25 Dec 2023
Osteoarthritis, Knee	Phase 2	CN	Xgene Pharmaceutical, Inc.	28 Nov 2022
Chronic Pain	Phase 2	CN	Xgene Pharmaceutical, Inc.	30 Jan 2022
Diabetic Neuropathies	Phase 1	CN	Xgene Pharmaceutical, Inc.	23 Sep 2020
Pain	Phase 1	AU	Xgene Pharmaceutical, Inc.	16 Oct 2017

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