Sucampo Announces Completion of Patient Enrollment in a Phase 3 Clinical Study
of Unoprostone Isopropyl for Retinitis Pigmentosa
Study Conducted by Development Partner R-Tech Ueno and Majority-Funded by
Japan Science and Technology Agency (JST)
BETHESDA, Md., Oct. 21, 2013 (GLOBE NEWSWIRE) -- Sucampo AG, a subsidiary of
Sucampo Pharmaceuticals, Inc. (Nasdaq:SCMP) ("Sucampo"), today announced that
its development partner, R-Tech Ueno, Ltd. (R-Tech), completed the enrollment
on-time for a Phase 3 study of unoprostone isopropyl ophthalmic solution 0.15%
for the treatment of retinitis pigmentosa (RP). R-Tech is conducting the
clinical trial at 38 medical institutions in Japan.
The randomized, double-blind, placebo-controlled study will evaluate whether
unoprostone isopropyl ophthalmic solution improves central retinal sensitivity
as determined by Humphrey Field Analyzer (HFA) in patients with RP. The
study's primary endpoint is the value of mean retinal sensitivity at four
central points at one year, and the target sample size is 180 patients.
"There are no drugs currently approved for the treatment of RP anywhere in the
world, and we believe that unoprostone isopropyl may be a promising candidate
for this indication," said Ryuji Ueno, M.D., Ph.D., Ph.D., Chairman, Chief
Executive Officer and Chief Scientific Officer of Sucampo. "With the
completion of the Phase 3 trial enrollment, R-Tech expects to complete this
study by the end of 2014 with top-line results available in early 2015. Upon
successful results, Sucampo intends to work with regulatory authorities in the
United States and the European Union to determine the incremental data that
will be necessary to form application packages for each region, and we look
forward to the possibility of helping to meet the unmet needs of patients
suffering from RP in these countries."
This study is being funded through an agreement established in February 2013
between R-Tech and the Japan Science and Technology Agency (JST), the
governmental agency responsible for the implementation of science and
technology policy in Japan (News Release - Feb. 4, 2013). Sucampo licensed
from R-Tech the exclusive development and commercialization rights to
unoprostone isopropyl globally except for Japan, Peoples Republic of China,
Taiwan, and Korea. Both the U.S. Food and Drug Administration and the European
Medicines Agency have granted orphan drug designation to unoprostone isopropyl
for treatment of RP.Sucampo is not responsible for any development costs for
the Phase 3 RP trial in Japan.
Retinitis pigmentosa is a genetic disease characterized by progressive,
irreversible vision loss and decreasing visual acuity. As RP progresses, daily
life becomes increasingly difficult. Blindness from all causes is among the
most significant injuries to a patient's qualify of life and is a major driver
of patient-based cost of care and lifestyle maintenance.
Further details of the study can be found at www.clinicaltrials.gov using the
About Unoprostone Isopropyl
Unoprostone isopropyl, a member of Sucampo's family of ion channel activators
knows as prostones, is a synthetic docosanoid that may have a local effect on
BK (Big Potassium) channels in the eye. BK channels are expressed in neural
and contractile tissues like retina and vascular smooth muscle. A form of
unoprostone isopropyl, with a trade name RESCULA®, is currently approved in
the U.S. for use in patients with open-angle glaucoma or ocular hypertension.
Important Safety Information
RESCULA is contraindicated in patients with hypersensitivity to unoprostone
isopropyl or any other ingredient in this product.
Warnings and precautions
Unoprostone isopropyl ophthalmic solution may gradually increase the
pigmentation of the iris. The pigmentation change is believed to be due to
increased melanin content in the melanocytes rather than to an increase in the
number of melanocytes. The long term effects of increased pigmentation are not
known. Iris color changes seen with administration of unoprostone isopropyl
ophthalmic solution may not be noticeable for several months to years.
Treatment with RESCULA solution can be continued in patients who develop
noticeably increased iris pigmentation. Patients who receive treatment with
RESCULA should be informed of the possibility of increased pigmentation which
is likely to be permanent.
Unoprostone isopropyl has been reported to cause pigment changes (darkening)
to periorbital pigmented tissues and eyelashes. The pigmentation is expected
to increase as long as unoprostone isopropyl is administered, but has been
reported to be reversible upon discontinuation of unoprostone isopropyl
ophthalmic solution in most patients.
RESCULA should be used with caution in patients with active intraocular
inflammation (e.g., uveitis) because the inflammation may be exacerbated.
Macular edema, including cystoid macular edema, has been reported. RESCULA
should be used with caution in aphakic patients, in pseudophakic patients with
a torn posterior lens capsule, or in patients with known risk factors for
To minimize contaminating the dropper tip and solution, care should be taken
not to touch the eyelids or surrounding areas with the dropper tip. Keep
bottle tightly closed when not in use. There have been reports of bacterial
keratitis associated with the use of multiple-dose containers of topical
RESCULA contains benzalkonium chloride, which may be absorbed by soft contact
lenses. Contact lenses should be removed prior to application of solution and
may be reinserted 15 minutes following its administration.
In clinical studies, ocular adverse events above 5% with use of RESCULA were
burning/stinging (22.4%), burning/stinging upon drug instillation (18.6%),
itching (13.2%), injection (11.6%), dry eyes (10.7%), foreign body sensation
(9.0%), abnormal vision (8.2%), lacrimation disorder (6.2%) and eyelid
disorder (5.8%). Approximately 10-14% of patients were observed to have an
increase in the length of eyelashes (≥ 1mm) at 12 months, while 7% of patients
were observed to have a decrease in the length of eyelashes. Corneal lesions
were reported in 2.3% of patients.
The most frequently reported nonocular adverse event associated with the use
of RESCULA in the clinical trials was flu-like syndrome, observed in
approximately 6% of patients.
Use in specific populations
Pregnancy Category C - There are no adequate and well-controlled studies in
pregnant women. Because animal studies are not always predictive of human
response, RESCULA should be used during pregnancy only if the potential
benefit justifies the potential risk to the fetus.
Pediatric Use - the safety and efficacy of RESCULA in pediatric patients have
not been established.
It is not known whether RESCULA is excreted in human milk. Because many drugs
are excreted in human milk, caution should be exercised when RESCULA is
administered to a nursing woman.
No overall differences in safety or effectiveness of RESCULA have been
observed between elderly and other adult populations.
About Sucampo Pharmaceuticals, Inc.
Sucampo Pharmaceuticals, Inc., is focused on the discovery, development and
commercialization of drugs based on ion channel activators knows as prostones.
Discovered by the company's scientific founder, prostones are naturally
occurring fatty acid metabolites with unique physiological activities. Sucampo
has two marketed products – AMITIZA® and RESCULA – and a pipeline of
prostone-based product candidates in clinical development. A global company,
Sucampo is headquartered in Bethesda, Maryland, and has operations in the
United Kingdom, Switzerland and Japan. For more information, please visit
The Sucampo logo and the tagline, The Science of Innovation, are registered
trademarks of Sucampo AG. RESCULA is a registered trademark of R-Tech Ueno,
Ltd, and has been licensed to Sucampo AG.
About R-Tech Ueno, Ltd.
R-Tech Ueno is a publicly traded company listed on the JASDAQ exchange. It is
a bio-venture company established in September 1989 for the purpose of R&D and
marketing of drugs. Under the leadership of CEO Yukihiko Mashima, M.D., Ph.D.,
also a medical doctor, the company is developing new drugs on the theme
"Physician-Oriented New Drug Innovation," targeting ophthalmologic and
dermatologic diseases that previously had no effective therapeutic agent.
Sucampo Forward-Looking Statement
This press release contains "forward-looking statements" as that term is
defined in the Private Securities Litigation Reform Act of 1995. These
statements are based on management's current expectations and involve risks
and uncertainties, which may cause results to differ materially from those set
forth in the statements. The forward-looking statements may include statements
regarding product development, product potential, future financial and
operating results, and other statements that are not historical facts. The
following factors, among others, could cause actual results to differ from
those set forth in the forward-looking statements: the impact of
pharmaceutical industry regulation and health care legislation; Sucampo's
ability to accurately predict future market conditions; dependence on the
effectiveness of Sucampo's patents and other protections for innovative
products; the risk of new and changing regulation and health policies in the
U.S. and internationally and the exposure to litigation and/or regulatory
actions. No forward-looking statement can be guaranteed and actual results may
differ materially from those projected. Sucampo undertakes no obligation to
publicly update any forward-looking statement, whether as a result of new
information, future events, or otherwise. Forward-looking statements in this
presentation should be evaluated together with the many uncertainties that
affect Sucampo's business, particularly those mentioned in the risk factors
and cautionary statements in Sucampo's most recent Form 8-K and 10-K, which
Sucampo incorporates by reference.
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CONTACT: Silvia Taylor
Senior Vice President, IR, PR, and Corporate Communications
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