Rebiotix Leaders to Discuss Microbiome Product Development Challenges and Regulation at Microbiome Movement – Drug Development Summit 2019
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ROSEVILLE, MN – June 26, 2019 — Rebiotix, Inc., a Ferring Pharmaceuticals company, announced today that two members of their senior leadership team, Dr. Ken Blount, Chief Scientific Officer and Dr. Edward Burd, Head of Regulatory Affairs, will engage in key panel discussions at the 2019 Microbiome Movement – Drug Development Summit. The fourth annual summit will take place on June 26-28 in Boston, MA.
An established figure in the microbiome field, Dr. Blount will speak at the Microbiome Industry Leaders panel, where he will highlight the ongoing scientific and product-development challenges within the category, including highlights from Rebiotix’s clinical and microbiome research under the company’s innovative, investigational MRT™ drug platform.
In addition to the panel, Dr. Blount will deliver a presentation about Rebiotix’s pioneering Microbiome Health Index™ (MHI). The talk will focus on the company’s advances in developing the algorithm as a means to assess restoration of a patient’s microbiome communities after treatment with one of the company’s investigational MRT formulations. Currently, there are two formulations in clinical development – the lead candidate, RBX2660, is a liquid suspension in Phase 3; RBX7455, an investigational, first-of-its-kind lyophilized, non-frozen, room-temperature stable oral capsule formulation. Both formulations are currently focused on reducing recurrent Clostridioides difficile (C. diff) infection in adults.
“It is exciting to take part in an event that showcases innovations that harness the power of the microbiome. I am honored to participate in the Microbiome Industry Leaders panel to engage with other authorities in the field,” said Dr. Blount. “It’s events like these that enable us to come together, share ideas and shape the future prospect of microbiome-based therapies.”
Beyond scientific and clinical innovation in the category, the regulatory landscape for microbiota-based therapies continues to evolve. Initially outlined by the U.S. Food and Drug Administration (FDA) in 2013, additional standards specific to fecal microbiota transplantation (FMT) are anticipated in the near future and continue to be a focal point of discussion. To highlight the most recent developments and impact on the field, Dr. Burd will chair the Building Clear Regulatory Guidelines for Microbiome-based Therapeutics panel during the summit. The panel will address the growing complexities within microbiome product development, including donor testing, product characterization, and the dynamic international regulatory landscape for this emerging class of products.
“It is critical that the players in this space focus on developing safe products and procedures for the patients we serve,” said Dr. Burd. “With representatives from key microbiome companies and regulatory bodies offering commentary on this important topic, we can continue to emphasize the need for regulatory oversight and careful clinical investigation when it comes to patient-safety.”
Details for the panels and presentation are as follows:
- Title: Microbiome Industry Leaders Panel Discussion
- Date and Time: Thursday, June 27, 2019 8:30 AM
- Title: A Prototype Biomarker for Microbiome Rehabilitation in Patients with Clostridium Difficile Infections: Application to a Clinical Trial of a Lyophilized, Non-Frozen, Oral, Microbiota-Based Drug RBX7455
- Date and Time: Friday, June 28, 2019 12:30PM; Track C
- Title: Building Clear Regulatory Guidelines for Microbiome-based Therapeutics
- Date and Time: Thursday, June 27, 2019 6:15 PM
For more information regarding the Microbiome Movement – Drug Development Summit 2019, please visit https://microbiome-summit.com.
About RBX2660 and RBX7455
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 Status designations from the U.S. Food and Drug Administration (US FDA). Rebiotix’s clinical pipeline also features RBX7455, a lyophilized, non-frozen, oral capsule part of a recently completed investigator-sponsored Phase 1 trial studied for the reduction of recurrent C. diff infection.
About Rebiotix Inc.
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 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 personalized 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.
For more information, please contact:
+1 (651) 705-8774