Tag Archives: Biopharmaceutical

Ferring Pharmaceuticals Acquires Rebiotix, Inc.

Ferring acquires innovative biotechnology company and microbiome pioneer Rebiotix Inc.

  • Rebiotix’s RBX2660 is a non-antibiotic treatment in Phase 3 development for the prevention of recurrent Clostridium difficile infection (CDI) and has the potential to be the world’s first approved human microbiome product
  • CDI is one of the most common healthcare-associated infections in the US, affecting more than 500,000 people and causing approximately 29,000 deaths each year.1
  • Ferring’s global capabilities ensure broader patient access to any future approved human microbiome treatments derived from Rebiotix’s Microbiota Restoration Therapy™ (MRT™) drug platform

Saint-Prex, Switzerland & Roseville, MN, US – 05 April, 2018 — Ferring Pharmaceuticals* and Rebiotix Inc.  announce that they have agreed to the acquisition of Rebiotix by Ferring. This acquisition brings together two innovative healthcare companies that share a common commitment to exploring and understanding the human microbiome to develop new solutions for patients.

The most advanced investigational microbiome treatment from Rebiotix is RBX2660, a non-antibiotic treatment currently in Phase 3 development for the prevention of recurrent CDI. RBX2660 has the potential to be the first human microbiome product approved anywhere in the world. In the US, RBX2660 has received FDA Fast Track, Breakthrough Therapy and Orphan Drug Designations, which means the FDA considers it eligible for Expedited Review, once the submission has been made.

“The scientific advances Rebiotix has made add significant strategic value to Ferring’s leadership in gastroenterology,” said Michel Pettigrew, President of the Executive Board and Chief Operating Officer, Ferring Pharmaceuticals. “Therapies targeted towards the microbiome have the potential to transform healthcare. Together, we have a unique opportunity to help people living with debilitating and life-threatening conditions like Clostridium difficile infection.”

Rebiotix’s proprietary MRT drug platform delivers healthy, live, human-derived microbes into the gastrointestinal tract. It provides a standardised, stabilised product that is ready-to-use in an easy-to-administer format. The MRT pipeline consists of a number of investigational treatments including RBX7455, a non-frozen, lyophilised oral capsule formulation, in development for the prevention of recurrent CDI.

“Ferring shares our passion for understanding the role the microbiome plays in human health and has global capabilities that offer huge potential for the investigational therapies that we have in development,” said Lee Jones, Founder, President and Chief Executive Officer, Rebiotix, Inc. “Rebiotix was founded to revolutionise healthcare by harnessing the power of the human microbiome and this is a significant milestone in achieving that goal.”

“This acquisition strengthens our innovation pipeline and complements our own ongoing microbiome research as well as our partnerships with world-leading organisations in this area,” said Per Falk, Chief Science Officer, Ferring Pharmaceuticals. “Rebiotix’s culture and passion for high quality, innovative research fits with our own and complements our existing R&D capabilities.”

In addition to the acquisition of Rebiotix, Ferring, as a leader in gastroenterology, is supported by ongoing partnerships with world-leading research organisations in the field of microbiome research including the Karolinska Institutet and Science for Life Laboratory, the Centre for Translational Microbiome Research, Intralytix, The Institut Pasteur, the University of Lille, MyBiotics Pharma, March of Dimes and Metabogen.


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 women’s health, and in specialty areas within gastroenterology and urology. Ferring has been developing treatments for mothers and babies for over 50 years. Today, over one third of the company’s research and development investment goes towards finding innovative and personalised healthcare solutions to help mothers and babies, from conception to birth. Founded in 1950, 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.

About Rebiotix Inc.

Rebiotix Inc. is a late-stage clinical microbiome company focused on harnessing the power of the human microbiome to revolutionise the treatment of challenging diseases. Rebiotix possesses a deep and diverse clinical pipeline targeting several other disease states with drug products built on its pioneering MRT platform. The MRT platform is a standardised, stabilised drug technology that is designed to rehabilitate the human microbiome by delivering a broad consortium of live microbes into a patient’s intestinal tract via a ready-to-use and easy-to-administer format. For more information on Rebiotix and its pipeline of human microbiome-directed therapies, visit www.rebiotix.com.

About RBX2660

RBX2660 is the most advanced product utilising Rebiotix’s proprietary MRT drug platform. RBX2660 is in Phase 3 development for the prevention of recurrent CDI and has the potential to be the first human microbiome product approved anywhere in the world. It consists of a microbiota suspension of intestinal microbes and is administered via enema.

*Ferring Holding Inc. signed the agreement as part of Ferring Pharmaceuticals Group

Da Volterra Shared Results From Phase I Clinical Trial of DAV132 to Prevent Gut Microbiome Disruption Caused by Antibiotics and Prevent C. diff. Infections

DAV132 is a first-in-class product to protect the microbiome during antibiotic treatments and prevent Clostridium difficile infections.

French biotech Da Volterra is developing products to fight the rapidly rising rates of antibiotic resistance. During a Phase I study, the company’s medical device, DAV132, was used with the antibiotic, moxifloxacin, and successfully protected the intestinal microbiota from antibiotic residues. Overall, the product managed to reduce exposure of the microbiota to the antibiotic by 99% and maintain 97.8% of the microbiome’s genetic richness without affecting the drugs therapeutic efficacy.

In a randomized, controlled clinical trial performed in 44 healthy human volunteers, DAV132 was used in association with moxifloxacin, a widely used fluoroquinolone antibiotic. It was demonstrated that DAV132 is able to effectively capture residual antibiotics in the colon and reduce their concentration to very low levels. DAV132 reduced exposure of the intestinal microbiota to moxifloxacin by 99%. Meanwhile the plasma concentration of the antibiotic was essentially unaffected by the co-administration DAV132, meaning that its therapeutic efficacy will be maintained.

The ability of DAV132 to protect the intestinal microbiome was explored by identifying changes in bacterial gene richness as well as a detailed statistical analysis of the evolution of bacterial species throughout the study. In volunteers who received moxifloxacin alone, gene richness was drastically diminished to 54.6% of baseline after antibiotic treatment and failed to return to baseline even one month after treatment; 39% of bacterial species identified in the intestinal microbiota were affected. The co-administration of DAV132 with moxifloxacin largely protected the intestinal microbiome from disruption (97.8% of baseline for bacterial gene richness, and 93% of bacterial species protected).

The primary endpoints for the study were fully achieved and DAV132 showed an excellent tolerability profile.

Annie Ducher MD, Chief Medical Officer of Da Volterra, declared: “This clinical study is indicative of the potential of DAV132 to become one of the first preventative solutions to protect the intestinal microbiome and further avoid the detrimental consequences of antibiotic treatments, such as Clostridium difficile infections, for patients. We look forward to advancing the development of DAV132 in a pivotal patient study in 2018.”

Jean de Gunzburg PhD, Chief Scientific Officer of Da Volterra, added: “This study constitutes the first scientific demonstration of the protection of the intestinal microbiome from dysbiosis caused by a fluoroquinolone antibiotic treatment; our data suggests that this effect should be extendable to many different antibiotics from several therapeutic classes. The metagenomics analysis is outstanding and thoroughly convincing that DAV132 is highly effective at protecting the commensal bacteria in the intestines.”

The results are available under the reference: Gunzburg et al. Protection of the human gut microbiome from antibiotics. The Journal of Infectious Diseases, jix604, https://doi.org/10.1093/infdis/jix604.

***

About DAV132:
With a novel and unique mechanism of action, DAV132 is a product candidate aiming to protect the intestinal microbiome from the side effects of antibiotics, hence preventing the onset of C. difficile infections. DAV132 is an adsorbent with a proprietary coating with colon targeted delivery. DAV132 has been tested in four Phase 1 clinical studies with no adverse safety events. DAV132 is currently entering a Phase 2 clinical trial.

About Da Volterra:
Da Volterra is a biopharmaceutical company based in France that develops new strategies aimed at protecting the intestinal microbiome from the deleterious effects of antibiotics, and preventing multi-resistant and life-threatening infections. Da Volterra’s innovative approaches promise a substantial medical progress to combat deadly pathogens. http://www.davolterra.com

(January 2018)

To read the article in its entirety, please click on the following link to be redirected:

https://www.businesswire.com/news/home/20180116005398/en/Da-Volterra-Announces-Publication-Full-Results-Clinical

C. diff. Spores and More Global Broadcasting Network Welcomes Guests; Dr. Michael Stecher, Dr. Sushma Shivaswamy, and Mr. Kelly Thornburg of XBiotech

XBiotech will discuss their novel True Human ™ approach on Tuesday, February 2nd at
10 a.m. Pacific Time,,   11 a.m. Mountain Time,
12 p.m. Central Time,    1 p.m. Eastern Time.

on C. diff. Spores and More™”  Global Broadcasting Network – an educational program dedicated to  C. difficile Infections  and more —  brought to you by VoiceAmerica and sponsored by Clorox Healthcare

http://www.voiceamerica.com/show/2441/c-diff-spores-and-more

 

This episode introduces XBiotech, developer of True Human ™ therapeutic antibodies.  XBiotech has an exciting pipeline of product candidates in various areas of medicine.  The Company recently anounced the launch of a research and development program to develop a first-in-class oral monoclonal antibody against Clostridium difficile (C. diff. ) infection.  The Company will discuss the need for an effective C. difficile therapy, their novel approach to treating the infection as well as efficiency in their manufacturing technology.

Join guests Dr. Michael Stecher,MD,  Medical Director, Dr. Sushma Shivaswamy, Ph.D., Vice President of Research and Development and Mr. Kelly Thornburg, Senior Vice President of Operations as they discuss how XBiotech is pioneering a new era in the discovery and development of targeted antibodies therapeutics.

 

XBiotech

 

XBiotiech is rethinking the way medicines are discovered and commercialized– from pioneering ways to create safer drugs that harness our natural immunity to disease, to developing technology that enables rapid transition from discovery to large-scale manufacturing.  “At XBiotech we believe there is vast potential for next generation antibody therapies derived from natural immunity to disease.  We believe our innovation in technology and in the clinic enables us to bring our new discoveries to patients more efficiently than any other bio-pharmaceutical developer in the industry. ”