A Phase 2, Multi-centeR, Randomized, DoUBle-Masked, Placebo-Controlled StudY to Evaluate the Clinical Safety and Efficacy of OKG-0301 in the Treatment of Acute Adenoviral Conjunctivitis

Acute adenoviral conjunctivitis is a highly contagious, widespread endemic disease associated with frequent outbreaks, significant patient discomfort, lost productivity, and in some cases permanent visual compromise from long-term immune mediated sequelae. OKG-0301 is a novel ophthalmic solution with a potent ribonuclease that has broad-spectrum antiviral properties relevant for the treatment of acute adenoviral conjunctivitis. This randomized, double masked, multi-center Phase 2 study is being conducted entirely within Australia and is designed to support the safety and efficacy of OKG-0301 for the treatment of acute adenoviral conjunctivitis. The study intends to show superiority of OKG-0301 Ophthalmic Solution compared to vehicle for the primary efficacy endpoint of mean change from baseline in viral titre in patients with acute adenoviral conjunctivitis. Secondary efficacy endpoints including adenoviral eradication, clinical cure of acute adenoviral conjunctivitis, subepithelial infiltrates, other clinical signs and symptoms, and rate of cross-over infection to the other eye will also be assessed. Safety will also be evaluated.

开始日期2019-02-11

申办/合作机构

Okogen, Inc.初创企业

ACTRN12619000177156 / Recruiting临床2期

A Phase 2, Multi-centeR, Randomized, DoUBle-Masked, Placebo-Controlled StudY to Evaluate the Clinical Safety and Efficacy of OKG-0301 in the Treatment of Acute Adenoviral Conjunctivitis (RUBY)

开始日期2019-02-11

申办/合作机构-

100 项与豹蛙酶相关的临床结果

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100 项与豹蛙酶相关的转化医学

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100 项与豹蛙酶相关的专利（医药）

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项与豹蛙酶相关的文献（医药）

Pathogens

Ranpirnase (OKG-0301), a Novel Ribonuclease, Demonstrates Antiviral Activity against Adenovirus in the Ad5/NZW Rabbit Ocular Replication Model

Article

作者: Romanowski, Eric G ; Daniels, Eric J ; Kowalski, Regis P ; Strem, Brian M ; Romanowski, John E ; Yates, Kathleen A

Adenovirus ocular infections are common ocular viral infections seen worldwide, for which there is no approved antiviral therapy available. Ranpirnase is a novel ribonuclease which preferentially degrades tRNA resulting in an inhibition of protein synthesis. The study goal was to determine the anti-adenoviral activity of topical formulations of ranpirnase (OKG-0301) on adenoviral replication in the Ad5/NZW rabbit ocular replication model. NZW rabbits were inoculated in both eyes with human adenovirus type 5 (HAdV5) after corneal scarification. A day later, topical therapy was initiated in both eyes with 0.03% OKG-0301, 0.003% OKG-0301, saline or 0.5% cidofovir. Eyes were cultured to determine HAdV5 eye titers over 2 weeks. OKG-0301 (0.03% and 0.003%) and 0.5% cidofovir decreased viral titers compared to saline. Furthermore, both OKG-0301 formulations and 0.5% cidofovir shortened the duration of the HAdV5 infection compared to saline. Both 0.03% OKG-0301 and 0.003% OKG-0301 demonstrated increased antiviral activity compared to saline in the Ad5/NZW rabbit ocular replication model. The antiviral activity of the OKG-0301 groups was similar to that of the positive antiviral control, 0.5% cidofovir. Ranpirnase (OKG-0301) may be a potential candidate for a topical antiviral for adenoviral eye infections. Further clinical development is warranted.

项与豹蛙酶相关的新闻（医药）

2021-04-29

·BioSpace

Safe, Effective and Dose Responsive Anti-Viral Activity of OKG-0301 in Patients with Acute Adenoviral Conjunctivitis--Phase 2 Interim Analysis Results from RUBY Clinical Trial

San Diego, California and Melbourne, Australia--(News - April 29, 2021) - Okogen, a clinical-stage specialty ophthalmic biotechnology company announced the interim analysis results from RUBY, the company's Phase 2, double-masked, placebo-controlled clinical trial evaluating the safety and efficacy of OKG-0301 in patients with acute adenoviral conjunctivitis. In 58 patients diagnosed with acute adenoviral conjunctivitis, OKG-0301 was safe and demonstrated an effective, dose-dependent anti-viral response. This data will be presented by Professor Stephanie Watson (Principal Investigator of the RUBY Trial) in greater detail at the ARVO virtual annual meeting, May 1-7, 2021. To view the full announcement, including downloadable images, bios, and more, click here. Key Takeaways: In 58 patients diagnosed with acute adenoviral conjunctivitis, OKG-0301 was safe and demonstrated an effective, dose-dependent anti-viral response. Data to be presented at Association for Research in Vision and Ophthalmology (ARVO) annual conference being held May 1-7, 2021 Building off this data, the company has put forth its planned clinical development steps to the US FDA, outlining a phase 3 program to begin in 2022. Click image above to view full announcement. About Okogen Okogen is a clinical-stage, specialty biotechnology company focused on developing therapeutics to help patients with ocular diseases. The company's lead development candidate, OKG-0502, is a fixed dose combination of a broad-spectrum antiviral (OKG-0301) that functions intracellularly to inhibit viral replication and an ocular decongestant that addresses the associated signs and symptoms of adenoviral conjunctivitis. These mechanisms of action are further expected to provide clinical benefit in addressing adenoviral infections of the eye as well as other classes of viruses that are active in the ocular space, including herpes simplex virus, varicella-zoster virus, and more. For more information about Okogen, visit . To learn more about the RUBY trial, visit or clinicaltrials.gov (NCT03856645). Contacts: Brian M. Strem, Ph.D. info@okogen.com Source: Okogen To view the source version of this press release, please visit

100 项与豹蛙酶相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D05702	-	-	DB04950

研发状态

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
结膜炎	临床2期	-	Tamir Biotechnology, Inc.	-
腺病毒性结膜炎	临床前	澳大利亚	Okogen, Inc.初创企业	2019-02-11

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临床结果

适应症

分期

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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


ARVO2021	临床2期	腺病毒科感染	219	OKG-0301 0.03%	(齋觸窪鏇鹹餘鏇遞壓襯) = 積鬱選鹽鬱積遞蓋窪願願顧選艱夢膚鬱淵鑰製 (齋築窪選鑰製鬱艱憲觸, +/ ~ 0.27)	-	2021-06-01
				OKG-0301 0.012%	(齋觸窪鏇鹹餘鏇遞壓襯) = 糧選壓鏇鏇醖膚窪齋積願顧選艱夢膚鬱淵鑰製 (齋築窪選鑰製鬱艱憲觸, +/ ~ 0.27)
RUBY (Corporate Publications) 人工标引	临床2期	腺病毒科感染	-	OKG-0301	(蓋窪壓觸艱鬱積淵製鑰) = statistically significant 選餘廠壓網鬱製窪製窪 (觸願製壓選醖築構鬱範 )	积极	2021-04-29
				Placebo