欢迎访问文传商讯!

全部新闻

Rebiotix, a Ferring Company, Completes Enrollment for First-Ever, Pivotal Phase 3 Clinical Trial of Microbiota-based RBX2660

发布时间:2020-02-05 10:01


Enrollment completion for the first Phase 3 clinical trial in microbiome industry
Largest randomized, double-blinded study, with over 300 patients enrolled aimed to demonstrate the potential benefit of RBX2660 in reducing rates of recurrent Clostridioides difficile (C. diff) infection
Rebiotix intends to use the results from the Phase 3 trial to serve as the basis for licensure application to the US FDA

SAINT-PREX, Switzerland -- (BUSINESS WIRE) --

Rebiotix, a Ferring company, announced today that it has completed enrollment of the pivotal Phase 3 clinical trial for RBX2660, an investigational therapy aimed at breaking the cycle of recurrent Clostridioides difficile (C. diff) infection, which is responsible for the deaths of thousands of people in the US alone. The Centers for Disease Control and Prevention (CDC) has classified C. diff as an urgent public health threat, with limited options for treatment.

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20200204005532/en/

RBX2660 was developed under Rebiotix’s investigational microbiota-based MRT™ drug platform with the goal of delivering standardized, stabilized formulations to meet unmet medical needs. Conducted in the US and Canada, this is the first Phase 3 trial of its kind to be completed using a broad consortia microbiota-based formulation.

“Rebiotix was founded to harness the power of the human microbiome to treat debilitating diseases,” said Lee Jones, Rebiotix Founder and CEO. “Microbiota-based therapies have shown tremendous potential as an innovative, non-antibiotic therapy, starting with C. diff. The completion of enrollment of this trial is a critical next step in making microbiota-based products accessible to patients - we are excited about this important milestone and look forward to sharing results later this year.”

The Phase 3 trial builds on the company’s extensive history with the formulation, including several hundred participants previously enrolled in multiple Phase 2 clinical trials. The robust data collected over the course of the company’s multi-year clinical development program will be eventually presented to the US FDA as part of a Biological License Application (BLA).

Ferring Pharmaceuticals, also with a rich and vast history of microbiome research of its own, led the industry by becoming the first major pharmaceutical company to acquire a microbiome therapeutics company in April 2018. Headquartered in Saint-Prex, Switzerland, Ferring is expected to have the first regulatory approved microbiota-based therapeutic in the world through the potential approval of the RBX2660 in the US.

About Clostridioides difficile Infection

Clostridioides difficile (also known as C. diff) is a bacterium that causes diarrhea and colitis (an inflammation of the colon). C. diff, impacts nearly a half a million people each year in the United States; of those impacted, up to one in five patients will experience a recurrent episode.1 In 2019, the U.S. Centers for Disease Control listed C. diff as an urgent threat to public health.2

About RBX2660

RBX2660 is currently in Phase 3 clinical development for the reduction of recurrent Clostridioides difficile (C. diff) infection. RBX2660 has been granted Fast Track, Orphan, and Breakthrough Therapy Status designations from the US FDA. For more information about the RBX2660 Phase 3 study, visit www.clinicaltrials.gov (NCT03244644).

About Rebiotix

Rebiotix Inc., part of the Ferring Pharmaceuticals Group, is a late-stage clinical microbiome company focused on harnessing the power of the human microbiome to revolutionize the treatment of challenging diseases. Rebiotix has a diverse pipeline of investigational drug products built on its pioneering microbiota-based MRT™ drug platform. The platform consists of investigational drug technologies designed to potentially rehabilitate the human microbiome by delivering a broad consortium of live microbes into a patient’s intestinal tract. For more information on Rebiotix and its pipeline of human microbiome-directed therapies for diverse disease states, visit www.rebiotix.com.

About Ferring Pharmaceuticals

Ferring Pharmaceuticals is a research-driven, specialty biopharmaceutical group committed to helping people around the world build families and live better lives. Headquartered in Saint-Prex, Switzerland, Ferring is a leader in reproductive medicine and maternal health, and in specialty areas within gastroenterology and urology. Founded in 1950, privately-owned Ferring now employs approximately 6,500 people worldwide, has its own operating subsidiaries in nearly 60 countries and markets its products in 110 countries.

Learn more at www.ferring.com, or connect with us on Twitter, Facebook, Instagram, LinkedIn and YouTube.

References:

1Centers for Disease Control and Prevention. What Is C. Diff?,17 Dec. 2018. Available at: https://www.cdc.gov/cdiff/what-is.html.

2enters for Disease Control and Prevention. Biggest Threats and Data, 14 Nov. 2019. Available at: https://www.cdc.gov/drugresistance/biggest-threats.html.

# # #

US-GAS-2000005

View source version on businesswire.com: https://www.businesswire.com/news/home/20200204005532/en/

CONTACT:

For more information, please contact
Courtney Jones
Marketing Manager
Rebiotix Inc., A Ferring Company
+1 651 705 8774 (Office)
courtney.jones@ferring.com

Lindsey Rodger
Senior Manager, Corporate Communications
Ferring Pharmaceuticals Inc.
+41 58 451 4023 (direct)
+41 79 191 0486 (mobile)
lindsey.rodger@ferring.com

金联创 xinhua08 cacs takungpao China.com 和讯 财讯 C114.net 看商界 畅享网 中国能源网 证券之星 金融界 中金在线 天和网 中国金融网 中汽传媒 国际财经日报 中国环保网 今日亚洲新闻网 百歌新闻专线 亚洲商机 新华网能源频道 IT资讯网 中国智能卡论坛 广西物流网 品牌世家 汽车点评网 中国电子标签网 360教育在线 21世纪保险网 中国能源投资网 中国电子商业联盟 中国汽车咨询中心网 煤炭供应链 美国证券网 百奥知 CTI论坛 中国测控网 北极星电力网 能源财经网 福建之窗 智库在线 eeworld 电脑商情在线 中国电池网 赢商网 湖南信息港 赢在中国网 比邻星环保网 中国制造业门户 中国涂料在线 渝网 - 了解重庆第一站,重庆城市生活门户网站 中国云计算第一门户网站—中云网 投资界 i美股 天和财富网 太阳能信息网 爱中国能源网 世纪新能源网 中国新能源网 PVMate.com 环球外汇 橡胶网-hc360慧聪网 百年企业在线 IT168 米内 汽车工业网 第一车市汽车网 股市资讯 中国西部网 中原汽配网 科技在线 煤炭网 51招生网 教育人生 驴皮网 物流北京 51电池搜索网 大众医学 岭南医药网 5联网 股城网 BIT CNELC XXTLW 外汇通 供应链中国网 中国粘合剂网 中国储能网 家具迷 家居装修网 中華检测网 中国食品招商网 华东化工网 新疆第一汽车网 中国汽车用品交易网 大娱网 中国汽配网 山东化工网 960化工网 妈咪爱 塑胶五金网 慧聪电子网 迈点酒店网 火爆网 emcsino eetrend 绿色节能网 赤浪绿色新能源网 中国商业网 生物无忧 全球医疗器械网 贷商网 手机在线 汽车轻量化在线 中国汽车材料网 科易网 中国电子顶级开发网 中国POS机网 乐康家居 必修 国易网