As detailed in the Investigational New Drug (IND) application, which was accepted by the U.S. Food and Drug Administration (FDA) in April, Tobrate™ will initially be evaluated in a randomized, double-blind, single ascending dose/multiple ascending dose (SAD/MAD) Phase 1 pharmacokinetic (PK) study in 24 healthy volunteers. Data from the Phase 1 study is expected in the first quarter of 2017.
Enteris is also pleased to announce it has partnered with RRD International, LLC (RRD), a leading product development company providing expert-level support to biopharmaceutical companies, for the development of Tobrate™. Working closely with Enteris, under a product development structure, RRD will provide strategic, regulatory and clinical development support to advance Tobrate™ in the clinic through the end of Phase 2 meeting with FDA. As part of this relationship, RRD will share risk by taking an equity stake in Enteris.
"Our relationship with Enteris began late last year, collaboratively developing the regulatory strategy and clinical development pathway for Tobrate™," said Scott Tarrant, president of RRD International. "The announcement of our product development partnership signifies both our excitement in the Company's proprietary delivery technologies and the attractiveness an oral formulation of tobramycin offers to patients for the treatment of uUTI."
Mr. Tune commented, "We are excited that an industry leader like RRD has agreed to partner with us on the Tobrate program. Their willingness to take this project further validates our deep belief in the strength and broad applicability of our Peptelligence™ platform."
Since its founding in 2013, Enteris BioPharma has advanced multiple internal and external programs leveraging its Peptelligence™ platform. The technology has been developed and proven effective over the last decade to enable the safe delivery of peptide-based therapeutics and other molecules with low oral bioavailability. Currently, Enteris BioPharma's internal product pipeline consists of Ovarest™ (oral leuprolide tablet) and Tobrate™. External market analyses demonstrate projected annual U.S. revenue potential for these two products in excess of $1 billion in the aggregate.
Additionally, Enteris BioPharma's oral peptide delivery technology is the subject of several active external development programs, the most advanced of which include Tarsa Therapeutics' TBRIA, an oral calcitonin for patients with postmenopausal osteoporosis and an oral formulation of Cara Therapeutics' CR845, a potent peripheral kappa opioid receptor agonist which demonstrated positive safety, tolerability, PK and efficacy data in a recently completed Phase 2a clinical trial in chronic pain patients with osteoarthritis of the knee or hip.
About RRD International
RRD International is a product development company that provides integrated, expert-level strategic, regulatory and operational support to biopharmaceutical companies and investors. The Company's unique Product Development Team model (PDT) provides an effective, asset-centric alternative to traditional industry practices. While comprehensive in value, structure and function – encompassing all aspects of a development program including strategic planning, management and execution – the PDT model is also highly resource efficient with an intense focus on minimizing cost, time and risk to achieve human proof-of-concept (POC). Since 2002, RRD has worked with more than 100 organizations across all major classes and therapeutic areas. For more information, visit www.rrdintl.com.
About Enteris BioPharma
Enteris BioPharma, Inc. is a privately held, New Jersey-based biotechnology company offering innovative formulation solutions built around its proprietary drug delivery technologies. The Company's proprietary oral delivery technology – Peptelligence™ - has been the subject of numerous feasibility studies and active development programs, several of which are in late stage clinical development. Additionally, Enteris BioPharma has built and is advancing an internal product pipeline of oral tablet reformulations of drug products that address significant treatment opportunities for which there is no oral delivery option. Enteris BioPharma's internal pipeline currently consists of Ovarest™ (oral leuprolide tablet), a Phase 2a-ready oral peptide for endometriosis, and Tobrate™ (oral tobramycin tablet) for the treatment of uncomplicated urinary tract infection (uUTI).
For more information on Enteris BioPharma and its proprietary oral delivery technology, please visit www.EnterisBioPharma.com.
For Enteris BioPharma:
Brian Zietsman, President & CFO
Enteris Media Relations:
Jason Rando / Amy Wheeler
Tiberend Strategic Advisors, Inc.
To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/enteris-biopharma-initiates-clinical-program-for-tobrate-oral-tobramycin-tablet-in-uncomplicated-urinary-tract-infection-300297880.html
SOURCE Enteris BioPharma, Inc.