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Inotek Pharmaceuticals Announces Top-line Results of Phase 2 Fixed-dose Combination Trial of Trabodenoson and Provides Corporate Update


Pharmaceuticals Corporation
(NASDAQ:ITEK), a clinical-stage
biopharmaceutical company focused on the discovery, development and
commercialization of therapies for ocular diseases, today announced
top-line results of the Phase 2 fixed-dose combination (FDC) trial of trabodenoson
and latanoprost for the treatment of glaucoma. The trial was
designed to assess the benefit/risk profile of the different fixed-dose
combinations being evaluated. It was not powered for statistical
differences among doses. After 28 Days of once-daily morning treatment
(QAM), the fixed combination of trabodenoson 3% and latanoprost
0.005% showed a 1.2 mmHg improvement in intraocular pressure
(IOP) reduction compared to the latanoprost 0.005% alone (p=0.061
for the mean comparison, p=0.020 for the median comparison). However, at
Day 56, after 4 additional weeks of treatment and night-time dosing
(QPM), no meaningful clinical advantage in IOP reduction for the fixed
dose combinations was observed.

"While the top-line results, which we received and analyzed over the
past week, demonstrated a good safety and tolerability profile of the
fixed-dose combinations of trabodenoson and latanoprost,
the efficacy of the FDC was only marginally differentiated from that of latanoprost
alone. When dosed in the AM and examined on Day 28, the trabodenoson 3%/latanoprost
0.005% combination showed 1.2 mmHg additivity to commercial latanoprost.
However by Day 56, while the IOP lowering effect of latanoprost
improved by 1.3 mmHg, the fixed dose combination of trabodenoson/latanoprost
remained unchanged. Therefore, the addition of trabodenoson to latanoprost
offered no clinically meaningful advantage in eye pressure reduction
over latanoprost alone," commented David P. Southwell, President
and Chief Executive Officer of Inotek. "Based on these results and the
results previously reported for our Phase 3 MATrX-1 monotherapy trial,
we are evaluating the future clinical potential of trabodenoson,
as well as other strategic options."

Mr. Southwell continued, "We remain focused on the interests of Inotek
shareholders and are committed to enhancing shareholder value. Inotek is
well-capitalized with an estimated $109M in cash and marketable
securities as of the end of the second quarter of 2017."

Inotek also announced today that it is exploring its strategic
alternatives. It has engaged Perella Weinberg Partners as a financial
advisor to assist with the strategic review process. There can be no
assurance a transaction will result from this process and Inotek does
not intend to disclose additional details unless and until it has
entered into a specific transaction or otherwise determines that further
disclosure is appropriate.

About the Phase 2 Fixed-dose Combination Trial of Trabodenoson and

The randomized, double-masked, Phase 2
dose-ranging trial assessed 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 FDCs of trabodenoson and latanoprost were
investigated as well as two separate concentrations of latanoprost
alone. The treatments were: 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 201 subjects (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 was
administered to both eyes for a total of eight weeks.

The primary endpoint of the FDC trial measured IOP reduction from
diurnal baseline for a two month treatment period. The treatment period
was divided into two four-week periods consisting of double-masked AM or
PM dosing. The table below has the Daily IOP Change from Diurnal
Baseline for the trial.


After 4 weeks
QAM (LS Mean)


After 4 weeks
QPM (LS Mean)


Significance vs LTN
0.005% LS Mean


Significance vs LTN
0.005% Median

                  QAM QPM     QAM QPM
Trabo 6%/LTN 0.005%    

-6.3 mmHg

    -6.2 mmHg     0.367 0.219     0.175 0.275
Trabo 3%/LTN 0.005%     -6.9 mmHg     -7.0 mmHg     0.061 0.999     0.020 0.791
Trabo 6%/LTN 0.0025%     -5.8 mmHg     -6.4 mmHg     0.612 0.527     0.695 0.893
LTN 0.005%     -5.7 mmHg     -7.0 mmHg                
LTN 0.0025%     -5.5 mmHg     -5.9 mmHg                
All 3 FDC vs LTN 0.005%     0.226 0.374     0.109 0.244
Trabo 6%/LTN 0.005% and Trabo 3%/LTN 0.005% vs LTN 0.005%     0.107 0.477     0.032 0.432

Top-line results suggest that after 28 days of AM dosing, the FDC composed
of trabodenoson 3%/latanoprost 0.005% provided greater IOP
lowering when compared to latanoprost alone. However, by Day 56,
after 4 weeks of PM dosing, no clinical meaningful additivity was
observed. This was driven by the fact that the efficacy of PM latanoprost
improved by 1.3 mmHg from Day 28 to Day 56.

There were no significant safety or tolerability events reported,
consistent with previous trials of trabodenoson. The most common
adverse event for the fixed-dose combination was urinary tract infection
(12.7% in overall trabodenoson/latanoprost combinations, 12.2% in latanoprost
0.005%, and 11.9% in latanoprost 0.0025%). Only 1 subject
discontinued the trial due to a treatment-related adverse event, and
this subject was randomized to the latanoprost 0.0025%
monotherapy group (2.4% of this group). There were no discontinuations
in any of the FDC groups and the incidence of hyperemia between the
overall trabodenoson/latanoprost combinations and the latanoprost
alone groups were similar which continues to support that trabodenoson
is not associated with hyperemia.

For more information on the trial, please visit

Conference Call Information
Inotek will host a conference
call and webcast on Monday, July 10, 2017, at 8:30 am ET to discuss the
top-line results from the FDC trial. To participate in the conference
call, please dial (844) 358-9183 in the U.S. or (478) 219-0400 outside
of the U.S. five minutes prior to the start of the call and provide the
Conference ID: 51052887, or access the listen-only webcast by visiting
the Company's website

An archive of today's conference call will be available shortly after
the conclusion of the call and accessed by dialing (855) 859-2056 in the
U.S. or (404) 537-3406 outside of the U.S. and referencing the
Conference ID: 51052887, or by visiting Inotek's website. The audio
replay will be available for two weeks following the call and the
webcast for thirty days.

About Inotek Pharmaceuticals Corporation
Pharmaceuticals is a clinical-stage biopharmaceutical company focused on
the discovery, development and commercialization of therapies for
glaucoma and other eye diseases. For more information, please visit
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 Statements
Various statements in this
release concerning Inotek's future expectations, plans and prospects,
including without limitation, Inotek's expectations regarding the use of trabodenoson
and its fixed-dose combination (FDC) program with latanoprost as
treatments for primary open-angle glaucoma or ocular hypertension;
Inotek's expectations regarding reporting top-line data of its Phase 2
trial for its FDC; Inotek's expectations with respect to the timing and
success of its clinical studies and pre-clinical studies for trabodenoson
its FDC, orphan diseases, and the possibility of selective adenosine
mimetics to address optic neuropathies and other degenerative retinal
diseases, including NAION, and to improve the patho-physiology
associated with dry eye disease; may constitute forward-looking
statements for the purposes of the safe harbor provisions under The
Private Securities Litigation Reform Act of 1995 and other federal
securities laws and are subject to substantial risks, uncertainties and
assumptions. You should not place reliance on these forward looking
statements, which often include words such as "believe," "expect,"
"anticipate," "intend," "plan," "will give," "estimate," "seek," "will,"
"may," "suggest" or similar terms, variations of such terms or the
negative of those terms. Although the Company believes that the
expectations reflected in the forward-looking statements are reasonable,
the Company cannot guarantee such outcomes. Actual results may differ
materially from those indicated by these forward-looking statements as a
result of various important factors, including, without limitation,
Inotek's ability to successfully demonstrate the efficacy and safety of
, its FDC program, its pre-clinical studies for orphan
diseases, or selective adenosine mimetics to address optic neuropathies
and other degenerative retinal diseases, including NAION, and to improve
the patho-physiology associated with dry eye disease, the pre-clinical
and clinical results for its product candidates, which may not support
further development and marketing approval, the potential advantages of
Inotek's product candidates, actions of regulatory agencies, which may
affect the initiation, timing and progress of pre-clinical studies and
clinical trials of its product candidates, Inotek's ability to obtain,
maintain and protect its intellectual property, Inotek's ability to
enforce its patents against infringers and defend its patent portfolio
against challenges from third parties, the timing, cost or other aspects
of a potential commercial launch of Inotek's product candidates and
potential future sales of our current product candidates or any other
potential products if any are approved for marketing, competition from
others developing products for similar uses, Inotek's ability to manage
operating expenses, Inotek's ability to obtain additional funding to
support its business activities and establish and maintain strategic
business alliances and new business initiatives, Inotek's ability to
identify and execute on its strategic alternatives, Inotek's dependence
on third parties for development, manufacture, marketing, sales and
distribution of product candidates, the outcome of litigation, and
unexpected expenditures, as well as those risks more fully discussed in
the section entitled "Risk Factors" in Inotek's most recent Quarterly
Report on Form 10-Q filed with the Securities and Exchange Commission as
well as discussions of potential risks, uncertainties, and other
important factors in Inotek's subsequent filings with the Securities and
Exchange Commission. 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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