G03-52-01(G03-52-01) - 药物靶点：toxA x toxB_专利_临床

概要

基本信息

药物类型

生物药

别名-

靶点

toxA x toxB

作用机制

toxA抑制剂(艰难梭菌毒素A抑制剂)、toxB抑制剂(艰难梭菌毒素B抑制剂)

治疗领域-

在研适应症-

非在研适应症-

原研机构

Resilience Government Services, Inc.

在研机构

Resilience Government Services, Inc.

非在研机构-

最高研发阶段临床2期

首次获批日期-

最高研发阶段(中国)-

特殊审评-

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关联

2

项与 G03-52-01 相关的临床试验

NCT05348993

/ Active, not recruiting临床2期

A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacodynamics, and Immunogenicity of G03-52-01 in Adult Subjects

A Phase 2, randomized, double-blind, placebo-controlled single or repeat dose trial

开始日期2022-06-29

申办/合作机构

Resilience Government Services, Inc.

[+1]

NCT04171115

/ Completed临床1期

A Phase 1, Randomized, Double-Blind, Dose Escalation Study to Evaluate the Safety and Pharmacokinetics of a Single IM Dose of G03-52-01 vs Placebo in Adult Subjects

A Phase 1, randomized, double-blind, placebo-controlled dose escalation trial of four dose cohorts of 10 subjects (1: 10mg, 2: 25mg, 3: 50mg, 4: 100mg).

开始日期2020-06-01

申办/合作机构

Resilience Government Services, Inc.

[+1]

100 项与 G03-52-01 相关的临床结果

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100 项与 G03-52-01 相关的转化医学

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100 项与 G03-52-01 相关的专利（医药）

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2

项与 G03-52-01 相关的文献（医药）

Toxins2区 · 医学

Neutralizing Concentrations of Anti-Botulinum Toxin Antibodies Positively Correlate with Mouse Neutralization Assay Results in a Guinea Pig Model

2区 · 医学

ArticleOA

作者: Farr-Jones, Shauna ; Niemuth, Nancy ; Marks, James D ; Pham, Khanh ; Martinez, Zacchary ; Kobs, Dean ; Hackett, Michael J ; Tomic, Milan T ; Snow, Doris M ; Cobb, Ronald R ; Syar, Emily S ; Espinoza, Yero

Botulinum neurotoxins (BoNT) are some of the most toxic proteins known and can induce respiratory failure requiring long-term intensive care. Treatment of botulism includes the administration of antitoxins. Monoclonal antibodies (mAbs) hold considerable promise as BoNT therapeutics and prophylactics, due to their potency and safety. A three-mAb combination has been developed that specifically neutralizes BoNT serotype A (BoNT/A), and a separate three mAb combination has been developed that specifically neutralizes BoNT serotype B (BoNT/B). A six mAb cocktail, designated G03-52-01, has been developed that combines the anti-BoNT/A and anti-BoNT/B mAbs. The pharmacokinetics and neutralizing antibody concentration (NAC) of G03-52-01 has been determined in guinea pigs, and these parameters were correlated with protection against an inhalation challenge of BoNT/A1 or BoNT/B1. Previously, it was shown that each antibody demonstrated a dose-dependent mAb serum concentration and reached maximum circulating concentrations within 48 h after intramuscular (IM) or intraperitoneal (IP) injection and that a single IM injection of G03-52-01 administered 48 h pre-exposure protected guinea pigs against an inhalation challenge of up to 93 LD50s of BoNT/A1 and 116 LD50s of BoNT/B1. The data presented here advance our understanding of the relationship of the neutralizing NAC to the measured circulating antibody concentration and provide additional support that a single IM or intravenous (IV) administration of G03-52-01 will provide pre-exposure prophylaxis against botulism from an aerosol exposure of BoNT/A and BoNT/B.

Toxins2区 · 医学

A Monoclonal Antibody Combination against both Serotypes A and B Botulinum Toxin Prevents Inhalational Botulism in a Guinea Pig Model

2区 · 医学

ArticleOA

作者: Tomic, Milan T ; Kobs, Dean ; Marks, James D ; Martinez, Juan ; Farr-Jones, Shauna ; Collins, Laura ; Terpening, Sara ; Cobb, Ronald R ; Niemuth, Nancy ; Syar, Emily S ; Snow, Doris M ; Finger-Baker, Isaac ; Barnewall, Roy

Botulinum neurotoxins (BoNT) are extremely potent and can induce respiratory failure, requiring long-term intensive care to prevent death. Recombinant monoclonal antibodies (mAbs) hold considerable promise as BoNT therapeutics and prophylactics. In contrast, equine antitoxin cannot be used prophylactically and has a short half-life. Two three-mAb combinations are in development that specifically neutralize BoNT serotype A (BoNT/A) and B (BoNT/B). The three-mAb combinations addressing a single serotype provided pre-exposure prophylaxis in the guinea pig inhalation model. A lyophilized co-formulation of six mAbs, designated G03-52-01, that addresses both A and B serotypes is in development. Here, we investigated the efficacy of G03-52-01 to protect guinea pigs against an aerosol exposure challenge of BoNT/A1 or BoNT/B1. Previously, it was found that each antibody demonstrated a dose-dependent exposure and reached maximum circulating concentrations within 48 h after intramuscular (IM) or intravenous (IV) injection. Here we show that G03-52-01, in a single IM injection of G03-52-01 administered 48 h pre-exposure, protected guinea pigs against an aerosol challenge of up to 238 LD50s of BoNT/A1 and 191 LD50s of BoNT/B1. These data suggest that a single IM administration of G03-52-01 provides pre-exposure prophylaxis against botulism from an aerosol exposure of BoNT/A1 or BoNT/B1.

100 项与 G03-52-01 相关的药物交易

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研发状态

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临床结果

适应症

分期

评价

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT04171115 (CTgov)	临床1期	-	40	Placebo+G03-52-01 (10mg of G03-52-01)	網簾鹽衊製鏇齋鑰選築(獵鹹鹹淵積範膚遞淵餘) = 衊艱範築遞艱繭觸築鑰襯衊願範遞繭窪鬱顧夢 (簾簾鹽窪築艱選鬱齋構, 製繭構觸憲鬱糧壓範鑰 ~ 艱願鏇製淵鏇獵範襯築) 更多	-	2024-10-04
				Placebo+G03-52-01 (25mg of G03-52-01)	網簾鹽衊製鏇齋鑰選築(獵鹹鹹淵積範膚遞淵餘) = 廠築遞襯顧範醖壓鏇廠襯衊願範遞繭窪鬱顧夢 (簾簾鹽窪築艱選鬱齋構, 鹽網憲齋餘鬱鬱遞鬱鹹 ~ 簾鬱築膚膚淵鑰醖廠構) 更多