UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d)
of The Securities Exchange Act of 1934
Date of Report (Date of Earliest Event Reported): November 29, 2016
Inotek Pharmaceuticals Corporation
(Exact name of registrant as specified in its charter)
| DELAWARE | 001-36829 | 04-3475813 | ||
| (State or other jurisdiction of incorporation) |
(Commission File Number) |
(I.R.S. Employer Identification No.) | ||
| 91 Hartwell Avenue Lexington, MA |
02421 | |||
| (Address of principal executive offices) | (Zip Code) | |||
Registrant’s telephone number, including area code (781) 676-2100
Not Applicable
(Former name or former address, if changed since last report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
| ☐ | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
| ☐ | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
| ☐ | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
| ☐ | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
| Item 7.01 | Regulation FD Disclosure |
Inotek Pharmaceuticals Corporation (the “Company”) is furnishing an investor presentation, attached as Exhibit 99.1 to this Report on Form 8-K, which the Company intends to use from time to time in meetings with investors and others beginning on November 29, 2016. The investor presentation will also be available on the Company’s website at http://ir.inotekpharma.com.
The information in this Report on Form 8-K and Exhibit 99.1 attached hereto is intended to be furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934 (the “Exchange Act”) or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933 or the Exchange Act, except as expressly set forth by specific reference in such filing.
| Item 9.01 | Financial Statements and Exhibits. |
(d) Exhibits
| Exhibit |
Description | |
| 99.1 | Inotek Pharmaceuticals Corporation November 2016 Corporate Presentation. | |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| Date: November 29, 2016 | INOTEK PHARMACEUTICALS CORPORATION
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| By: | /s/ Dale Ritter | |||||
| Dale Ritter | ||||||
| Vice President —Finance | ||||||
EXHIBIT INDEX
| Exhibit |
Description | |
| 99.1 | Inotek Pharmaceuticals Corporation November 2016 Corporate Presentation. | |
Exhibit 99.1
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November 2016 Corporate Presentation
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Forward Looking Statements
This presentation contains forward-looking statements that are based on our management’s belief and assumptions and on information currently available to our management. Although we believe that the expectations reflected in these forward-looking statements are reasonable, these statements relate to future events or our future financial performance, and involve known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance or achievements to be materially different from any future results, levels of activity, performance or achievements expressed or implied by these forward-looking statements.
In some cases, you can identify forward-looking statements by terminology such as “may,” “might,” “could,” “would,” “will,” “should,” “expect,” “intend,” “plan,” “anticipate,” “believe,” “estimate,” “predict,” “project,” “target,” “potential,” “continue” or the negative of these terms or other comparable terminology. These statements are only predictions. You should not place undue reliance on forward-looking statements because they involve known and unknown risks, uncertainties and other factors, which are, in some cases, beyond our control and which could materially affect results. If one or more of these risks or uncertainties occur, or if our underlying assumptions prove to be incorrect, actual events or results may vary significantly from those implied or projected by the forward-looking statements. No forward-looking statement is a guarantee of future performance.
The forward-looking statements in this presentation represent our views as of the date of this presentation. We anticipate that subsequent events and developments will cause our views to change. However, while we may elect to update these forward-looking statements at some point in the future, we have no current intention of doing so except to the extent required by applicable law. You should therefore not rely on these forward-looking statements as representing our views as of any date subsequent to the date of this presentation.
All trademarks and registered trademarks are the property of their respective owners.
Trabodenoson is an investigational compound and is not yet approved by the FDA for any indication.
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Inotek: Transforming Glaucoma Treatment
Phase 1 Monotherapy showed no Phase 2 Monotherapy showed clear First Phase 3 Monotherapy, dose related side effects (ocular or dose response, good ocular and MATrX-1, tests QD and BID systemic) at greater than Phase 3 systemic safety, ability to dose QD or doses against placebo. Results doses BID, additive efficacy to prostaglandins to be announced early Jan. 2017
First fixed-dose combination trial initiated in 2016 | Adenosine A1 activation is neuroprotective in the retina and brain.2-4
1Schwartz GF & Quigley HA, Survey of Ophthalmology 2008;53: S57-S58 2Gomes et al. 2011, 3Zhong et al. 2013, 4Cunha 2005
*Source: IMS Health in 2013
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Leadership with History Together
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$2 Billion U.S. Glaucoma Market
Unmet Need: Effective QD treatment with minimal side effects
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IOP Elevation Drives Treatment
Objective: Normalized Intraocular Pressure (IOP)
-Administration ed-Dose
Combination
Market Opportunity as First or Second Line
First Line: IOP Lowering; Safety/Tolerability = Compliance
Second Line: Additive efficacy to latanoprost; Minimal added side effects, QD dosing
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Trabecular Meshwork:
The Natural Mechanism for Regulating IOP
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Trabodenoson’s Novel Mechanism*
• Binds to A1 receptors on Trabecular Meshwork
• Upregulates MMP-2, digesting extracellular matrix proteins that clog the TM
• Research supporting trabodenoson’s MOA presented at the 2016 American Glaucoma Society
*Increased secretion of MMPs contributes to trabodenoson-induced changes in conventional outflow facility;
DS Albers, CE Crosson, JS Myers, CC Rich, R Baumgartner, and WK McVicar; American Glaucoma Society Annual Meeting, March 2016, Poster #: PO047
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From Adenosine to Trabodenoson
Trabodenoson Rational Design
Trabodenoson is an adenosine mimetic optimized to selectively target the A1 receptor
Compound A1 (Ki, nM) A2a (Ki, nM) A3 (Ki, nM)
Trabodenoson 0.97 4,690 704
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Phase 1: Good Safety Profile and Tolerable
xicity; no dose-stemic side effects; osure at high doses
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| No Clinically Significant Safety Signals in Trials to Date | ||||||||
| Phase 1 Comprehensive Safety Assessments included: | ||||||||
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Continuous cardiac monitor |
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Adverse events | |||||
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12-lead ECG |
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Physical examinations | |||||
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Orthostatic BP and heart rate |
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Clinical laboratory assessments | |||||
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Vital signs |
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Toxicology screen | |||||
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Blood cardiac troponin I |
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Ophthalmology assessments | |||||
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Spirometry – FEV1 |
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Slit lamp exam/hyperemia | |||||
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Blood pharmacokinetic sampling |
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Fundus exam | |||||
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Urine pharmacokinetic sampling |
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Best-corrected visual acuity | |||||
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Intraocular pressure | |||||||
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Renal biomarkers |
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Karolinska sleepiness scale |
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No Clinically Significant Safety Signals in Trials to Date
Phase 1 Comprehensive Safety Assessments included:
Continuous cardiac monitor
12-lead ECG
Orthostatic BP and heart rate
Vital signs
Blood cardiac troponin I
Spirometry –FEV1
Blood pharmacokinetic sampling
Urine pharmacokinetic sampling
Renal biomarkers
Karolinska sleepiness scale
•Adverse events
•Physical examinations
•Clinical laboratory assessments
•Toxicology screen
•Ophthalmology assessments
Slit lamp exam/hyperemia
Fundus exam
Best-corrected visual acuity
Intraocular pressure
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Phase 2: IOP Statistically Lowered at All Timepoints on Day 28
Pre-randomization
Post-randomization
FIG. 2.
Mean IOP for the trabodenoson 500 mcg and placebo groups pre- randomization
(Day -1) and after post-randomization (Days 14, 28, and 29).
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Phase 2 Dose Ranging Trial: Hyperemia Score Graded (0-3)
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MATrX-1 Phase 3 Trial Design
Identical population to Phase 2
• IOP ³24 mmHg
• ~ 300 patients treated for 12 weeks
ClinicalTrials.gov Identifier: NCT02565173
Three trabodenoson doses
1000 mcg QD
2000 mcg QD
1500 mcg BID
Placebo controlled
Statistical comparator
Timolol 0.5% BID
Internal control
Not part of statistical
comparisonvb
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Timolol Trial Experience – Range of Results
Year
IOP Reduction
Study
Published
(mmHg)
Timolol Phase III13
1979
4.9-7.6
Timolol versus Betaxolol14
1986
8.4
Timolol versus Epinephrine15
1988
7.1-8.9
Timolol versus Dorzolamide16
1995
5.4-7.1
Timolol versus Latanoprost17
1995
6.7
Timolol versus Latanoprost18
1995
8.3
Timolol versus Travoprost19
2001
3.8-7.1
Timolol versus Bimatoprost20
2001
5.6
Timolol versus Combigan21
2005
4.3-6.2
Timolol versus Xalacom22
2010
7.2
Timolol versus Latanoprostene
2016
6.6-8.0
Bunod23
Timolol versus Latanoprostene
2016
6.6-7.9
Bunod24
13. Zimmerman et al. Arch Ophthalmol 1979; 14. Stewart et al. Arch Ophthalmol 1986; 15. Alexander et al. Ophthalmology 1988; 16. Strahlman et al. Arch Ophthalmol 1995; 17. Alm et al.
Ophthalmology 1995; 18. Watson et al. Ophthalmology 1996; 19. Netland et al. Am J Ophthalmol 2001; 20. Sherwood et al. Survey of ophthalmology 2001; 21. Craven et al. J Ocul Pharmacol Ther 2005;
22. Higginbotham et al. Arch Ophthalmol 2010; 23. Weinreb et al. Ophthalmology 2016; 24. Medeiros et al. Am J Ophthalmol 2016.
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Timolol
• Clinical efficacy in practice is lower than in clinical trials2
– Trinity Survey of 100 Ophthalmologists – Median IOP lowering of 4.5 mmHg (range 3.0 to 6.0 mmHg)
• IMS Data shows monotherapy use is low and continues to decline.3
• Real safety risks with timolol4
– Serious events, including death, have been reported even in patients with co-morbidities.
• While somewhat variable, timolol has generally demonstrated IOP drift over time (tachyphylaxis) 7-12
• 2 year data of people requiring second agent (LASER trial)
• Timolol dosing disadvantages: BID, loss of efficacy at night
1. Summary Health Statistics:NHIS:2014. 2. Trinity Health Survey:2016; 3. IMS Data; 4. Timoptic XE label; 5. Bachelor et al. Ophthalmology, 1979; 6. Schuman et al.
Ophthalmology, 2000; 7. Krieglstein et al. Klin Monatsbl Augenheilkd, 1979; 8. Steinert et al. Arch Ophthalmol, 1981; 9. Nielsen et al. Acta ophthalmologica, 1982; 10. Bengtsson et al. Invest Ophthalmol Vis Sci, 2001; 11. Gandolfi et al. Invest Ophthalmol Vis Sci, 1990; 12. Gandolfi et al. Invest Ophthalmol Vis Sci, 1996.
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Additional Phase 3 Trials
MATrX—2
Long—Term Safety Trial
• Similar design as MATrX-1
• Primary endpoint = safety
• Optimized dose to be selected from MATrX-1
• Greater IOP range
• Large sample size
• At least 300 patients treated for at least
6 months, and 100 patients for at least
12 months
• Similar patient population to Phase 2
Phase 3 Program
• Primary endpoint versus placebo
Optimized for Success:
• Higher doses than in Phase 2
– Below the maximum dose tested in Phase 1
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Phase 2 Fixed-dose Combination Trial of
Trabodenoson and Latanoprost
Trabo 6.0%
Trabo 6.0%
GOAL: Identify optimal benefit/
LP 0.005%
LP 0.005%
risk profile for confirmatory trials
Trabo 3.0%
Trabo 3.0%
• N ~165 subjects
LP 0.005%
LP 0.005%
• Diagnosis of ocular hypertension (OHT) or
Placebo
Trabo 6.0%
Trabo 6.0%
No Ocular
Primary Open-Angle Glaucoma (POAG)
LP 0.0025%
LP 0.0025%
• Baseline IOP ³25 and £34 mmHg
Run-In
Treatment
• Trabodenoson doses: 3% and 6%
LP 0.005%
LP 0.005%
• Latanoprost doses: 0.005% (commercial dose) and 0.0025%
LP 0.0025%
LP 0.0025%
• Subjects assigned 4 wks of AM and 4 wks of PM dosing in a masked manner 4 Weeks 4 Weeks
Data Readout: 2H 2017 Screening Washout Run-in Observation 2 Month Active Treatment (QD)
Period Period Period Period
Masked 4 Week AM and PM periods
1 to 14 1 to 39 5 to 9
Day 1 to Day 56
Days Days Days
7 Days
ClinicalTrials.gov Identifier: NCT 02829996
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Back of Eye: Potential for Orphan Indications Optic Neuropathies and Degenerative Retinal Diseases • Trabodenoson shows potential Adenosine receptors in the back of the eye/Retina in treating the back of the eye: Section through retina Retinal Layers Cells • Preclinical data support effect: Nerve fiber layer Inner limiting membrane – High Pressure Optic Neuropathy Ganglion cell layer Axons at surface of retina pass via optic nerve, chiasm, and tr to lateral geniculate body Model Inner plexiform layer – Eye drops shown to deliver drug to Ganglion cell Inner nuclear layer Müller cell (supporting glial cell) retina in rabbits and monkeys Bipolar cell A1 Receptors • Orphan indications being Amarcine cell Outer plexiform layer Horizontal cell evaluated: Rod Outer nuclear layer Cone – Retinitis Pigmentosa Pigment cells of choroid – Non-Arteritic Ischemic Optic Photoreceptor layer Neuropathy (NAION) Pigment epthelium 20
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Inotek Value Drivers e3 Meeting Glaucoma 360 Phase 3 MATrX-1 Trial ✓ Phase 3 MATrX-1 ✓ Presented Preclinical Results • Phase 3 MATrX-2 Initiation Research at AGS • Initiation of Phase 3 Results ✓ Presented at GTC BIO MATrX-2 • Monotherapy NDA ✓ ARVO Poster • Initiation of Submission Presentations Monotherapy Long- ✓ Publication of Phase term Safety Trial 1/2 Clinical Data • FDC Phase 2 Dose ✓ Initiated FDC Dose Ranging Results Ranging Trial ✓ Presented at OIS 21
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Thank you