Public Device & Biopharma Ophthalmology Company Showcase - Inotek Pharmaceuticals
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Public Device & Biopharma Ophthalmology Company Showcase - Inotek Pharmaceuticals at OIS@AAO 2016. Presenter: David Southwell, President & CEO Powered by: Healthegy For more ophthalmology innovation Visit us at www.ois.net
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Public Device & Biopharma Ophthalmology Company Showcase - Inotek Pharmaceuticals
- 1. Ophthalmology Innovation Summit at AAO 2016 DAVID P. SOUTHWELL, President & CEO October 13, 2016
- 2. 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. 2 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.
- 3. Inotek: Transforming Glaucoma Treatment 3 *Source: IMS Health in 2013 First fixed-dose combination trial initiated July 2016 1Schwartz GF & Quigley HA, Survey of Ophthalmology 2008;53: S57-S58. Phase 1 Monotherapy showed no dose related side effects (ocular or systemic) at greater than Phase 3 doses Phase 2 Monotherapy showed clear dose response, good ocular and systemic safety, ability to dose QD or BID, additive efficacy to prostaglandins First Phase 3 Monotherapy, MATrX-1, tests QD and BID doses against placebo. Results 4Q’16
- 4. * Per Latanoprost Package Insert Source: Share data represents total prescriptions for IMS Health in 2013 $2 Billion U.S. Glaucoma Market 4 Unmet Need: Effective QD treatment with minimal side effects
- 5. Trabodenoson’s Novel Mechanism* 5 • 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
- 6. Phase 1: Good Safety Profile and Tolerable 6 Laties A, et al. J Ocul Pharmacol Therap 2016;00:108. doi:10.1089/jop.2015.0147 No Dose Limiting Toxicity; no dose-related ocular or systemic side effects; limited systemic exposure at high doses
- 7. Phase 2: IOP Statistically Lowered at All Timepoints on Day 28 7 Myers JS, et al. J Ocul Pharmacol Therap 2016;00:1-8. doi:10.1089/jop.2015.0148 Pre-randomization Post-randomization FIG. 2. Mean IOP for the trabodenoson 500 mcg and placebo groups pre-randomization (Day −1) and post-randomization (Days 14, 28, and 29).
- 8. Placebo 50mcg 100mcg 200mcg 500mcg 0 1 2 3 Day -4 Day -1 Day 1 Day 14 Day 28 Placebo 50mcg 100mcg 200mcg 500mcg Placebo Run-In Drug Treatment Randomization 0 = none/trace 1 = mild 2 = moderate 3 = severe Phase 2 Dose Ranging Trial: Hyperemia Score Graded (0-3) 8 Hyperemia scores were low and unchanged by all doses of trabodenoson Myers et al., 2016, JOPT, e-pub ahead of print doi:10.1089/jop.2015.0148
- 9. MATrX-1 Phase 3 Trial Design 9 ClinicalTrials.gov Identifier: NCT02565173 Identical population to Phase 2 • IOP ≥24 mmHg • ~ 300 patients treated for 12 weeks 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 comparison Screening Period 1 to 14 Days Washout Period 1 to 39 Days Run-in Period 5 to 9 Days Observation Period 7 Days 3 Month Treatment Period Day 1 to Day 84 AM Timolol BID OU Trabodenoson 1500 mcg (4.5%) BID OU Trabodenoson 2000 mcg (6.0%) QD OU Placebo BID OU Day 28* Day 42* Day 84* Trabodenoson 1000 mcg (3.0%) QD OU Placebo BID No Ocular Treatment *Primary endpoint.
- 10. Phase 2 Fixed-dose Combination Trial of Trabodenoson and Latanoprost 10 GOAL: Identify optimal benefit/ risk profile for confirmatory trials ClinicalTrials.gov Identifier: NCT 02829996 LP 0.005% LP 0.005% LP 0.0025% LP 0.0025% Trabo 3.0% Trabo 3.0% LP 0.005% LP 0.005% Trabo 6.0% Trabo 6.0% LP 0.0025% LP 0.0025% Screening Period 1 to 14 Days Washout Period 1 to 39 Days Run-in Period 5 to 9 Days Observation Period 7 Days 2 Month Active Treatment (QD) Masked 4 Week AM and PM periods Day 1 to Day 56 4 Weeks 4 Weeks Trabo 6.0% Trabo 6.0% LP 0.005% LP 0.005% Placebo Run-In No Ocular Treatment • N ~165 subjects • Diagnosis of ocular hypertension (OHT) or Primary Open-Angle Glaucoma (POAG) • Baseline IOP ≥25 and ≤34 mmHg • Trabodenoson doses: 3% and 6% • Latanoprost doses: 0.005% (commercial dose) and 0.0025% • Subjects assigned 4 wks of AM and 4 wks of PM dosing in a masked manner Data Readout: 2H 2017
- 11. Inotek Value Drivers End-of Phase 2 Meeting Phase 3 MATrX-1 Initiation Presented at Glaucoma 360 Presented Preclinical Research at AGS Presented at GTC BIO ARVO Poster Presentations Publication of Phase 1/2 Clinical Data Initiated FDC Dose Ranging Trial Presenting at OIS • Top-Line Phase 3 MATrX-1 Results • Initiation of Phase 3 MATrX-2 • Initiation of Monotherapy Long-Term Safety Trial • FDC Phase 2 Dose Ranging Results • Initiation of FDC Phase 3 Trial • Phase 3 MATrX-2 Results • Monotherapy NDA Submission 11
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Notas del editor
- Hi, my name is David Southwell . . I’m President and CEO of Inotek Pharmaceuticals I’m here today to talk about glaucoma, an unmet need in the market And how our company, Inotek, is taking a new approach to treating glaucoma We are investigating both elevated IOP and the optic neuropathy that occurs in patients with glaucoma
- The glaucoma market is an attractive market-$5.6 billion worldwide. We haven’t seen innovation in medical therapies for glaucoma since the late 90s. And, this is a market with very low compliance. Our compound, Trabodenoson, is an adenosine mimetic that stimulates a natural pathway in the body. We also demonstrated additive efficacy to the prostaglandin, latanoprost We’re able to do this based on the safety profile of Trabodenoson. We’re expecting results in 4Q of this year.
- Glaucoma is an attractive market… $2 Billion in the U.S. We’ve already discussed the two main classes of available glaucoma drugs. These drugs have insufficient efficacy – in 50% of patients more than 1 is required in the effort to achieve target IOP reductions. They all come with side effects, including ocular tolerability and in the case of the 2nd line agents, systemic effects that can be serious safety issues in rare cases Poor tolerability and dosing frequencies of 2 or 3 times daily have a negative impact on patient compliance and thus put patients at risk of progressive vision loss We need new drugs with efficacy from MOAs complementary to existing drugs. There is an unmet need for a once daily treatment with effective IOP lowering and minimal side effects
- Trabo works at the TM, by increasing the metabolism of proteins that can clog the outflow path (the “drain”) and it allows the normal pressure control by the TM to be “reset” to a lower, healthier level. We have shown in animals the mechanism by which trabodenoson exerts its biological effect. Trabo binds to A1 receptors on Trabecular Meshwork. Upregulates MMP-2, digesting extracellular matrix proteins that clog the TM. This research was just presented at the American Glaucoma Society.
- Our Phase 1 results demonstrated Trabodenoson is safe and tolerable The chart on the left shows the design of the phase 1 trial. We dosed subjects up to 3200ug in a single eye dose administered BID for 14 days And up to 6400ug in both eyes (3200ug per eye) The chart on the right hand side of the slide shows how the systemic exposure to the drug is limited as the ocular dose increases. We believe this limited exposure helps to explain the complete lack of systemic effect detected in this trial.
- The solid green and blue curves seen here are the IOP measurements done at day 28 with the highest dose tested – in blue – and the matching Placebo group – in green. The hashed grey placebo curve shows the natural circadian changes in IOP over the day, in the placebo group before the study started. The difference between this curve and the green curve - measured 28 days later at the end of the study – is the placebo response. Our results showed the placebo response to be about 2mm, which is the same as the placebo response well–documented in the literature To see the IOP improvement over placebo, you need to look at the differences in the matched timepoints between the green and blue curves, statistically. What you see is that our drug, at every single timepoint, consistently lowered IOP relative to placebo. The endpoint and statistical testing in our ongoing Phase 3 trial is identical to this analysis from our phase 2 study, but will be done at several timepoints – 4, 6 and 12 weeks. The same subjects (POAG and OHT with IOPs >24 mmHg) in Phase 3, and all elements of the Phase 3 design were agreed to with FDA.
- Our Phase 3 program consists of three main trials The MATrX-1 trial has the same patient population and same statistical comparison as our phase 2 that was highly statistically significant and gives us confidence in the Phase 3 study outcome. This trial is right on target . .slightly ahead of our initial screening projections
- As you know, we had a successful End-of Phase 2 Meeting last year and we started our Phase 3 MATrX-1 trial This year, we have a busy year. We’re presenting at many medical congresses and are expecting data from our Phase 3 MATrX-1 trial by the end of the year.