Ligand Completes Enrollment of Phase 1 Clinical Trial of Captisol-enabled Iohexol
May 2, 2019Top-line data expected Q3 of 2019
Also reports recent results from clinician survey on radiocontrast
agent selection and use
SAN DIEGO–(BUSINESS WIRE)–Ligand Pharmaceuticals Incorporated (NASDAQ: LGND) announces
completion of enrollment of the Company’s Phase 1 clinical trial of its
internal Captisol-enabled (CE) Iohexol program. The CE-Iohexol program
is designed to develop a Captisol-enabled, next-generation contrast
agent for diagnostic imaging with a reduced risk of renal toxicity.
Ligand also provides below a summary of the findings of a survey of
clinicians on radiocontrast agent selection and use.
“We are pleased to announce the progress of CE-Iohexol and look forward
to reporting Phase 1 data later this year. This program holds the
potential to increase the safety of widely-used commercial contrast
agents, and, if successful, provide Ligand later-stage out-licensing
opportunities,” said John Higgins, Chief Executive Officer of Ligand. “A
key priority of Ligand’s business model is to conduct targeted R&D with
the goal of advancing programs to secure significant financial terms
upon out-license. Recent market research validates our view that there
is a substantial unmet need for safer radiocontrast agents.”
Overview:
-
Contrast agents are used to enhance diagnostic imaging. Despite their
benefits and widespread use, contrast agents may place patients at an
increased risk for acute kidney injury (AKI), especially those with
certain risk factors undergoing cardiac interventional procedures
utilizing intravascular iodinated contrast.1 -
CE-Iohexol is designed to reduce the risk of AKI during imaging
procedures where iodinated contrast agents are administered. -
In animal models CE-Iohexol has been shown to prevent nephrotoxicity
by more than 50%.2
Trial:
-
The goal of the Phase 1 clinical trial is to establish pharmacokinetic
bioequivalence to support subsequent clinical trials and to provide
the basis for submitting a 505(b)(2) new drug application to the U.S.
Food and Drug Administration. -
The trial design consists of a single-center, randomized,
double-blind, two-period crossover study to determine relative
bioavailability of CE-Iohexol and a reference Iohexol injection
(OMNIPAQUE™) after IV administration in a population of 24 healthy
adults (ClinicalTrials.gov identifier: NCT03869983).
Third Party Survey Results:
-
The primary objective of this study sponsored by Ligand was to obtain
directional guidance from hospital specialists involved in
contrast-enhanced angiography, and to learn of perceptions, practices
and unmet needs regarding radiocontrast agents used for angiography. -
More than 60 specialists from U.S. hospitals surveyed, including
interventional cardiologists, radiologists, nephrologists and
radiopharmacists. -
Safety was a clear, predominant priority identified for product
improvement by all groups surveyed. -
Cardiologists also reported safety as the most important factor in
selecting a contrast agent and identified safety as the greatest area
for improvement. -
98% of specialists surveyed reported pre-screening prospective
patients for elevated kidney risk. -
Overall 23% of prescreened patients were identified as having elevated
kidney risk. Nephrologists indicated the high-risk pool of patients to
be twice as large as radiologists (32% vs. 16%, respectively). -
Among all groups the risk of contrast-induced AKI was highest among
high renal risk patients and among patients undergoing emergency
procedures.
About Captisol-enabled Iohexol
More than 30 million imaging procedures are performed each year in the
U.S. Iodinated contrast agents represent more than 60% of all X-ray
imaging agents sold with an annual U.S. market of approximately $1.5
billion.3 Iohexol, the most widely-used injectable diagnostic
contrast agent for imaging procedures, has global sales exceeding $500
million3.
Contrast-induced acute kidney injury (CI-AKI) is the acute impairment of
renal function following intravascular administration of an iodinated
contrast agent, and occurs most frequently following coronary
angiography, percutaneous coronary intervention and contrast-enhanced
computed tomography, especially among patients at risk of renal injury
such as those with advanced age, diabetes or heart failure. CI-AKI is an
issue with broad medical visibility as more than 50% of cardiovascular
imaging procedures are performed in patients age 65 or older.4
Currently no products are approved to prevent or treat CI-AKI in this
setting, and therefore a significant opportunity exists for a safer
formulation. The goal is for CE-Iohexol to establish a new safety
standard that enables a future partner to gain meaningful market share.
About Captisol®
Captisol is a patent-protected, chemically modified cyclodextrin with a
structure designed to optimize the solubility and stability of drugs.
Captisol was invented and initially developed by scientists in the
laboratories of Dr. Valentino Stella, University Distinguished Professor
at the University of Kansas’ Higuchi Biosciences Center for specific use
in drug development and formulation. This unique technology has enabled
several FDA-approved products, including Amgen’s Kyprolis®,
Baxter International’s Nexterone®, Acrotech Biopharma’s
EVOMELA®, Melinta Therapeutics’ Baxdela™ and Sage
Therapeutics’ ZULRESSO™. There are many Captisol-enabled products
currently in various stages of development.
About Ligand Pharmaceuticals
Ligand is a biopharmaceutical company focused on developing or acquiring
technologies that help pharmaceutical companies discover and develop
medicines. Our business model creates value for stockholders by
providing a diversified portfolio of biotech and pharmaceutical product
revenue streams that are supported by an efficient and low corporate
cost structure. Our goal is to offer investors an opportunity to
participate in the promise of the biotech industry in a profitable,
diversified and lower-risk business than a typical biotech company. Our
business model is based on doing what we do best: drug discovery,
early-stage drug development, product reformulation and partnering. We
partner with other pharmaceutical companies to leverage what they do
best (late-stage development, regulatory management and
commercialization) to ultimately generate our revenue. Ligand’s Captisol®
platform technology is a patent-protected, chemically modified
cyclodextrin with a structure designed to optimize the solubility and
stability of drugs. OmniAb® is a patent-protected transgenic
animal platform used in the discovery of fully human mono-and bispecific
therapeutic antibodies. Ligand has established multiple alliances,
licenses and other business relationships with the world’s leading
pharmaceutical companies including Amgen, Merck, Pfizer, Gilead,
Janssen, Baxter International and Eli Lilly.
Follow Ligand on Twitter @Ligand_LGND.
Forward-Looking Statements
This news release contains forward-looking statements by Ligand that
involve risks and uncertainties and reflect Ligand’s judgment as of the
date of this release. These include statements regarding: the timing of
results from our Phase 1 clinical trial of CE-Iohexol; the potential
that Ligand’s CE-iohexol program to increase the safety of widely-used
commercial contrast agents and deliver significant out-licensing
opportunities; the market size of contrast agent procedures and the
addressable market of CE-Iohexol; the potential that CE-Iohexol could
reduce renal toxicity and deliver a safer radiocontrast agent; Ligand’s
expectations that it will partner the program or obtain a higher royalty
rate or milestone payments due to Ligand’s development activities;
Ligand’s view of that there is a significant unmet need for safer
radiocontrast agents; and the opinion of clinicians, including
cardiologist, on the need to address safety for radiocontrast agents;.
Actual events or results may differ from our expectations. For example,
there can be no assurances that the Phase 1 clinical trial will be
completed on the expected timeline or all; the Phase 1 clinical trial
may not produce positive results; Ligand may choose to abandon the
program for any reason or no reason; the anticipated benefits of
CE-Iohexol, including the possible improvements in kidney safety, may
not materialize; and Ligand may be unable to secure licensing partners
or buyers for products developed from the contrast agent program. The
failure to meet expectations with respect to any of the foregoing
matters may reduce Ligand’s stock price. Additional information
concerning these and other important risk factors affecting Ligand can
be found in Ligand’s prior press releases available at www.ligand.com as
well as in Ligand’s public periodic filings with the Securities and
Exchange Commission, available at www.sec.gov.
Ligand disclaims any intent or obligation to update these
forward-looking statements beyond the date of this press release, except
as required by law. This caution is made under the safe harbor
provisions of the Private Securities Litigation Reform Act of 1995.
References
- McCullough, J Am College of Cardiology 2016;68:1465-73
- Rowe ES, et al. Journal of Neuroimaging 2016; 26(5):511-8
-
The Global Imaging Agents Market (Report MCP-3336) Global Industry
Analysts, Inc., September 2016 - See: http://www.onlinejacc.org/content/71/11_Supplement/A1637
Contacts
Ligand Pharmaceuticals Incorporated
Todd Pettingill
[email protected]
(858)
550-7893
@Ligand_LGND
LHA
Bruce Voss
[email protected]
(310)
691-7100