BOONTON, N.J., Aug. 21,
2019 /PRNewswire/ -- Enteris BioPharma, Inc., a biotechnology
company developing innovative drug products built around its
proprietary oral peptide delivery technologies, today
announced its entry into a definitive licensing agreement with Cara
Therapeutics (Nasdaq: CARA) for Enteris' Peptelligence®
technology in the ongoing development of an oral formulation of
Cara's first-in-class KOR agonist, CR845/difelikefalin
(KORSUVA™). Peptelligence® is Enteris' proprietary
platform for the oral delivery of peptides and BCS class II, III
and IV small molecules.
The oral tablet formulation of KORSUVA™ (Oral KORSUVA™) was
engineered using Peptelligence®. Oral KORSUVA™ is
currently the subject of three separate Phase 2 clinical trials for
pruritis in patients with hepatic impairment due to primary biliary
cholangitis (PBC), stage III-V chronic kidney disease (CKD), and
atopic dermatitis (AD). The agreement announced today will
allow Cara to continue its Oral KORSUVA™ programs into Phase 3 and
beyond.
Under the terms of the deal, Enteris granted to Cara
Therapeutics a non-exclusive, royalty-bearing license to the
Peptelligence® technology to develop, manufacture and
commercialize Oral KORSUVA™ worldwide, excluding Japan and South
Korea. In exchange, Enteris will receive an upfront payment
equal to $8 million, with 50% payable
in cash and 50% payable in shares of Cara's common stock.
Cara is also obligated to pay Enteris milestone payments upon the
achievement of certain development, regulatory and commercial
milestones and low-single digit royalties based on net sales in the
licensed territory. Cara retains the right to buy-out the royalty
obligation for a period of two years under prespecified
conditions.
"This is a watershed moment for Enteris and our
Peptelligence® platform, and we greatly welcome the
opportunity to deepen our relationship with Cara Therapeutics in
the ongoing development of its Oral Korsuva™ pipeline," said
Joel Tune, CEO of Enteris BioPharma.
"The ability of our Peptelligence® platform to enable
the oral delivery of peptide therapeutics, such as
CR845/difelikefalin, is a potential game-changer for numerous
peptide and small molecule-based drugs in development and on the
market given the convenience and marketability of an orally
administered tablet in comparison to an injection. With Cara now
actively evaluating Oral KORSUVA™ in three separate Phase 2
clinical trials for differing pruritis indications, evidence
continues to mount suggesting that Peptelligence® not
only offers the ability to maximize the performance and
patient-acceptance of peptide therapeutics, but that entire
franchises could be developed around our technology."
"We are pleased to formalize our ongoing work with Enteris and
look forward to the continued advance of our Oral KORSUVA™ program,
which now includes three Phase 2 clinical trials in pruritis
settings," stated Derek Chalmers,
Ph.D., D.Sc., President and Chief Executive Officer of Cara
Therapeutics. "Effective treatment of pruritis remains a
significant unmet need in patients with atopic dermatitis, liver
disease and chronic kidney disease, adding to their discomfort and
seriously impacting patients' quality of life, including sleep
disruption, altered eating habits, anxiety and depression. We
believe that KORSUVA may provide a potential, first-in-class
therapeutic to treat pruritus across clinical populations, and the
ability to deliver it via an oral tablet formulation expands
patient accessibility to the benefits of the product, if
approved."
About Enteris BioPharma
Enteris BioPharma, Inc. is a
privately held, New Jersey-based
biotechnology company offering innovative formulation solutions
utilizing its proprietary drug delivery technology, Peptelligence.
The technology has been the subject of numerous feasibility studies
and active development programs, several of which are in late stage
clinical development. Additionally, Enteris BioPharma 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 most advanced
internal product candidate, Ovarest® (oral leuprolide
tablet), is an oral peptide being developed for the treatment of
endometriosis. Tobrate™ (oral tobramycin tablet) is also being
developed by Enteris BioPharma for the treatment of uncomplicated
urinary tract infection (uUTI). A third internal compound,
octreotide, is currently in preclinical development. For more
information on Enteris BioPharma and its proprietary oral delivery
technology, please visit http://www.EnterisBioPharma.com.
For Enteris
BioPharma:
|
Brian Zietsman,
President & CFO
+1.973.453.3527
Enteris Media
Relations:
Jason
Rando
Tiberend Strategic
Advisors, Inc.
+1.212.375.2665
jrando@tiberend.com
|
View original
content:http://www.prnewswire.com/news-releases/enteris-biopharma-and-cara-therapeutics-enter-into-licensing-agreement-for-peptelligence-to-advance-development-of-oral-korsuva-300905076.html
SOURCE Enteris BioPharma, Inc.