Inotek Completes Patient Recruitment in Phase 2 Trial of a Fixed-dose Combination (FDC) of Trabodenoson and Latanoprost
April 11 2017 - 7:00AM
Business Wire
- Scheduled to Meet with FDA on Monotherapy
Program –
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
the Phase 2 dose-ranging trial of a fixed-dose combination (FDC) of
trabodenoson and latanoprost for the treatment of glaucoma.
Trabodenoson is a highly selective adenosine mimetic that
lowers intraocular pressure (IOP) by augmenting the natural
function of the trabecular meshwork, the primary outflow pathway in
the eye. Latanoprost, a prostaglandin analog, targets the secondary
uveoscleral pathway and is the most commonly used drug for lowering
IOP. Top-line data from the FDC study are expected in July.
“We have completed active recruitment of glaucoma patients in
our Phase 2 FDC trial,” said David P. Southwell, President and
Chief Executive Officer of Inotek. “This is an important milestone
as we continue to believe our FDC program has the potential to
address a larger market opportunity than monotherapy and provide
patients with a novel treatment option that includes two
complementary eye pressure lowering mechanisms. We look forward to
reporting the top-line results in July.”
Inotek also announced today that the Company has secured a
meeting with the US Food and Drug Administration (FDA) in the
second quarter to discuss the trabodenoson monotherapy program.
“Inotek has submitted a briefing book to the FDA detailing the
results of the completed MATrX-1 trial in order to seek their
guidance on its continued development,” said Rudolf Baumgartner,
MD, Executive Vice President and Chief Medical Officer of Inotek.
“We look forward to communicating the potential path forward for
the monotherapy program once it is better defined.”
About the Phase 2 Fixed-dose Combination Study of
Trabodenoson and LatanoprostThe randomized, double-masked,
Phase 2 dose-ranging trial will assess the overall benefit/risk
profile of binocular topical application of different daily doses
of trabodenoson (3.0% and 6.0%) when combined with latanoprost
(0.005% or 0.0025%) for eight weeks in patients with ocular
hypertension or primary open-angle glaucoma.
Three treatment combinations of trabodenoson and latanoprost
will be investigated as well as two separate concentrations of
latanoprost alone. The treatments are: trabodenoson 6%/latanoprost
0.005%, trabodenoson 3%/latanoprost 0.005%; trabodenoson
6%/latanoprost 0.0025%; latanoprost 0.005%; and latanoprost
0.0025%. Trabodenoson doses were selected to optimize IOP lowering,
while maintaining the favorable tolerability and safety profile
observed to date. Latanoprost doses were selected based on
efficacy and safety profiles which vary based on dose.
The trial enrolled approximately 200 patients (original
enrollment was exceeded due to a lower than anticipated screen
failure rate) with an IOP greater than or equal to 25 mmHg and less
than or equal to 34 mmHg; which represents the patients most likely
to receive treatment for glaucoma or ocular hypertension. Following
a placebo run-in period, treatment will be administered to both
eyes for a total of eight weeks.
For more information, please visit
www.clinicaltrials.gov/ct2/show/NCT02829996.
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. You should not place reliance on
these statements which often include words such as "believe,"
"expect," "anticipate," "intend," "plan," "estimate," "seek,"
"will," "may" or similar expressions. Although the Company believes
that the expectations reflected in the forward-looking statements
are reasonable, the Company cannot guarantee such outcomes.
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/20170411005143/en/
Inotek Contact:Claudine Prowse, PhD, 781-552-4305Vice
President, Corporate Development and IROIR@inotekpharma.com
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