Inotek Pharmaceuticals Announces the Completion of the Recruitment Phase of MATrX-1, the First Phase 3 Clinical Trial of Trab...
August 24 2016 - 7:00AM
Business Wire
- Top-line Data Expected in December 2016 -
Inotek Pharmaceuticals Corporation (NASDAQ: ITEK), a
clinical-stage biopharmaceutical company focused on the discovery,
development and commercialization of therapies for ocular diseases,
today announced the completion of the active recruitment phase of
MATrX-1, the first pivotal Phase 3 trial of trabodenoson for the
treatment of glaucoma. Trabodenoson, the Company’s lead clinical
candidate, is a first-in-class selective adenosine A1 mimetic under
investigation for reduction of intraocular pressure (IOP) which has
been observed in Phase 2 clinical trials to reduce IOP. Top-line
data from the MATrX-1 study are expected in December 2016.
“As anticipated, MATrX-1 has recruited on time, consistent with
our fourth-quarter guidance for top-line data,” said Rudolf
Baumgartner, MD, Executive Vice President and Chief Medical
Officer. “Trabodenoson has the potential to be a convenient, safe
and innovative treatment option for patients suffering from
glaucoma based on its targeted approach of restoring the natural
pressure-regulating process in the eye to lower IOP, and we are
looking forward to the results of this trial.”
About the MATrX-1 Phase 3 TrialMATrX-1 is a Phase 3
randomized, double-masked, placebo-controlled trial of trabodenoson
in (~)335 patients suffering from primary open angle glaucoma
(POAG) or ocular hypertension (OHT) that is designed to assess the
efficacy, safety and tolerability of trabodenoson over three months
of treatment. The primary endpoint is reduction of IOP as compared
to the placebo treatment arm. The study includes three doses of
trabodenoson: 3% (1000 mcg) once daily, 4.5% (1500 mcg) twice
daily, and 6% (2000 mcg) once daily. In addition, the study
contains a timolol 0.5% arm to validate the sensitivity of the
patient population and will serve as an internal control.
Enrollment criteria include patients with IOP greater than or equal
to 24 mm Hg and less than or equal to 34 mm Hg, which represents
the patients most likely to receive treatment for glaucoma or
ocular hypertension.
About Inotek Pharmaceuticals CorporationInotek
Pharmaceuticals is a clinical-stage biopharmaceutical company
focused on the discovery, development and commercialization of
therapies for glaucoma and other eye diseases. The Company’s lead
product candidate, trabodenoson, is a first-in-class selective
adenosine mimetic currently in Phase 3
development. Trabodenoson was developed in Inotek’s
laboratories and is designed to restore the eye’s natural pressure
control mechanism. Additionally, the Company is evaluating the
potential for selective adenosine mimetics to address optic
neuropathies and other degenerative retinal diseases. For more
information, please visit www.inotekpharma.com. The inclusion of
our website address here and elsewhere in this press release does
not include or incorporate by reference the information on our
website into this press release.
Forward-Looking StatementsThis press release contains
forward-looking statements, which are subject to substantial risks,
uncertainties and assumptions. These forward-looking statements
often include words such as “believe,” “expect,” “anticipate,”
“intend,” “plan,” “estimate,” “seek,” “will,” “may” or similar
expressions. Accordingly, you should not place undue reliance on
these forward-looking statements. All such statements speak only as
of the date made, and the Company undertakes no obligation to
update or revise publicly any forward-looking statements, whether
as a result of new information, future events or otherwise.
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version on businesswire.com: http://www.businesswire.com/news/home/20160824005271/en/
Inotek Contact:Claudine Prowse, Ph.D., 781-552-4305Vice
President, Strategy, Business Development, and
IROIR@inotekpharma.comorInvestor Contact:MacDougall
Biomedical CommunicationsChris Erdman,
781-235-3060cerdman@macbiocom.comorMedia Contact:MacDougall
Biomedical CommunicationsKaren Sharma,
781-235-3060ksharma@macbiocom.com
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