BOONTON, N.J., Jan. 7, 2021 /PRNewswire/ --
- Rajiv Khosla, Ph.D., named Chief
Executive Officer
- Gary A. Shangold, M.D.,
appointed Chief Medical Officer
- Received two milestone payments totaling $5 million from Cara Therapeutics per licensing
agreement for Peptelligence to advance development of Oral
KORSUVA™
-
- Additional potential milestone payments expected over the next
several quarters, subject to the achievement of certain development
milestones for Oral KORSUVA
- Oral KORSUVA currently the subject of three separate, ongoing
clinical programs focused on distinct pruritis indications
- Expansion of manufacturing facility to enable Phase 3 and small
volume commercial scale production, including dedicated containment
for High Potency Active Pharmaceutical Ingredients (HPAPIs), is
expected to be operational within the first few months of 2021
Enteris BioPharma, Inc., a biotechnology company developing
innovative drug products based on its proprietary delivery
technologies, and a wholly-owned subsidiary of SWK Holdings
Corporation (Nasdaq: SWKH), provided a review of its 2020 business
achievements and development activities as the company anticipates
growth opportunities during 2021 involving its industry-leading
Peptelligence® and ProPerma™
oral peptide and small molecule delivery technologies, and
extensive pharmaceutical expertise.
"2020 was a year unlike any in recent times with the COVID-19
pandemic impacting all aspects of business and society.
Despite the challenges, Enteris persevered, and we are now
positioned for a variety of growth opportunities built around our
transformative oral delivery technologies, Peptelligence and
ProPerma," said Rajiv Khosla, Ph.D.,
Chief Executive Officer of Enteris. "Key to our success in 2020,
and our ongoing optimism, is the strong, collaborative relationship
between Enteris and SWK Holdings. With SWK's support, we have
enacted and are beginning to see the results of a multi-pronged
strategy to establish Enteris as the industry leader in
enabling the safe and efficacious oral delivery of peptides and
other molecules with low oral bioavailability. The foundation
we built in 2020, including a reconstitution of our senior
leadership, will enable us to maximize this very sizable
opportunity through the advancement of external development
agreements, our own internal development pipeline, and
implementation of our manufacturing capability."
Executive Appointments – New Chief Executive Officer and
Chief Medical Officer
During 2020, Enteris significantly enhanced the company's
executive leadership with the appointment of Dr. Khosla as Chief
Executive Officer and Gary A.
Shangold, M.D., as Chief Medical Officer. Collectively, Drs.
Khosla and Shangold bring more than 60 years' industry experience
to Enteris with expertise in business development, intellectual
property monetization, drug development, regulatory relations and
product commercialization. Importantly, both executives
possess a deep knowledge of several drug delivery systems
technologies, which will be critical to Enteris as the company
seeks to capture more value-creating opportunities and maximize the
potential of its comprehensive pharmaceutical proficiency.
Dr. Khosla continued, "Since being appointed CEO in May 2020, I have worked closely with Enteris'
leadership, including Gary Shangold,
and the SWK team to implement several measures focused on
strengthening the company's internal and external operations.
Namely, we have initiated an aggressive business development and
marketing program designed to identify and secure potential
licensing opportunities with pharmaceutical companies seeking to
develop orally delivered versions of their peptide and small
molecule products. We have made significant inroads with
several companies, which we will continue to advance during
2021."
"Additionally, under the direction of our Chief Operating
Officer, Paul Shields, Enteris has
completed the physical construction of our expanded manufacturing
facility. We now have the ability to produce clinical trial
material (CTM) through to Phase 3, including dedicated containment
for HPAPIs. Having a manufacturing facility of this sophistication
is an important growth opportunity for Enteris, not only for our
existing partners, but also in our efforts to secure new,
high-value relationships. Remarkably, Paul and his team were able
to advance the construction of this facility on schedule despite
disruptions caused by COVID-19."
Cara Therapeutics Milestone Payments and Oral KORSUVA
Clinical Advancements
Enteris advanced its work with Cara Therapeutics per the
definitive licensing agreement for Peptelligence in the ongoing
development of an oral formulation of Cara's first-in-class KOR
agonist, CR845/difelikefalin (Oral KORSUVA). During the fourth
quarter of 2020, Enteris received two separate milestone payments
from Cara totaling $5 million.
Enteris is eligible to receive additional potential milestone
payments, subject to the achievement of certain development
milestones for Oral KORSUVA in 2021.
Oral KORSUVA is currently the subject of three separate
late-stage clinical trials for pruritus in patients with hepatic
impairment due to primary biliary cholangitis (PBC), stage III-V
chronic kidney disease (CKD), and atopic dermatitis (AD).
Previously, Cara announced positive top-line results from its Phase
2 clinical trial of Oral KORSUVA for the treatment of pruritus in
patients with stage III-IV (moderate-to-severe) chronic kidney
disease. Since then, Cara announced it intends to complete an
End of Phase 2 Meeting with the FDA in the first quarter of
2021. Separately, Cara announced that it has completed full
enrollment of its KARE Phase 2 dose-ranging clinical trial of Oral
KORSUVA for the treatment of moderate-to-severe pruritus in atopic
dermatitis patients.
Dr. Khosla continued, "The licensing agreement with Cara is an
important value driver for Enteris as it showcases our ability to
monetize our Peptelligence and ProPerma platforms via the
development of oral formulations for partner companies.
Additionally, the comprehensive nature of the collaboration, has
clearly demonstrated the depth and breadth of pharmaceutical
expertise at Enteris, including analytical method development, GMP
manufacture, and novel formulation
development.
Foreseeing Multiple Growth Drivers in 2021 and Beyond
Dr. Khosla concluded, "We expect 2021, subject to any COVID-19
constraints, to be a positive year for Enteris, with the continued
support of SWK, as we implement several initiatives started in
2020, and which have positioned us very well for our future
growth. We will advance our activities to secure partnerships
with pharmaceutical and biotech companies to develop oral tablet
formulations of molecules with low oral bioavailability utilizing
our novel technology. In addition, we will actively pursue
partnership discussions with companies seeking US domestic CDMO
capabilities, such as manufacture of clinical trials material
(CTM), formulation development, and analytical method development,
including for HPAPIs."
About Enteris BioPharma
Enteris BioPharma, Inc. is a wholly-owned subsidiary of SWK
Holdings Corporation (Nasdaq: SWKH) offering innovative formulation
solutions utilizing its proprietary drug delivery technologies,
Peptelligence® and ProPerma™.
The technologies have 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 endocrine
disorders. 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.
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SOURCE Enteris BioPharma, Inc.