Slide 1: Heron Post-Operative Pain Program: HTX-011 Phase 1 Single-Ascending-Dose Study
Heron Post-Operative Pain Program: HTX-011 Phase 1 Single-Ascending-Dose Study HERON THERAPEUTICS Advancing medicine. Improving Health.
Slide 2: Legal Disclaimer
Legal 4Disclaimer This presentation contains “forward-looking statements” as defined by the Private Securities Litigation Reform Act of 1995. These forward-looking statements involve risks and uncertainties, including uncertainties associated with the development, regulatory approval, manufacture, l
Slide 3: Heron Post-Operative Pain Program Objective
Heron Post-Operative Pain Program Objective: Develop a best-in-class therapeutic for post-operative pain 3 HERON THERAPEUTICS Advancing medicine. Improving Health.
Slide 4: Target Product Profile
Heron Post-Operative Pain Program Target Product Profile: Maximal pain relief that lasts for 2-3 days Maximal reduction of opioid use Maximal reduction of length of hospital stay Elimination of dose-limiting peak of bupivacaine 4 HERON THERAPEUTICS Advancing medicine. Improving Health.
Slide 5: Introducing HTX-011
Heron Post-Operative Pain Program Introducing HTX-011: An injectable pain therapeutic that utilizes proprietary Biochronomer® polymer-based drug delivery platform technology Contains both bupivacaine (anesthetic) and meloxicam (anti-inflammatory) Designed to deliver both drugs evenly over 2-3 days w
Slide 6: HTX-011 Phase 1 Single-Ascending-Dose Study Design
HTX-011 Phase 1 Single-Ascending-Dose Study Design Randomized, Single-Blind, Placebo-Controlled 3 Single Rising Dose Cohorts 144 hr pharmacokinetic & pharmacodynamic assessments Cohort 3 Min 7-day Observation Safety PK evaluation 400 mg HTX-011 (5 active:1 placebo) Min 7-day Observation Cohort 2 Saf
Slide 7: Plasma Concentrations of Bupivacaine Observed with HTX-011
Plasma Concentrations of Bupivacaine Observed with HTX-011 600 500 (ng/ml) 400 300 Bupivacaine 200 Plasma 100 0 0 24 48 72 96 120 144 Hours HTX-011 100 mg HTX-011 200 mg HTX-011 400 mg 7 HERON THERAPEUTICS Advancing medicine. Improving Health.
Slide 8: HTX-011 Provides Longer Duration of Bupivacaine Release without a Large Initial Peak
HTX-011 Provides Longer Duration of Bupivacaine Release without a Large Initial Peak 900 800 700 (ng/ml) 600 500 Bupivacaine 400 300 Plasma 200 100 0 0 24 48 72 96 120 144 Hours HTX-011 400 mg Exparel Hemorrhoidectomy 300 mg* * Exparel data extracted from FDA Clin Pharm review 8 HERON THERAPEUTICS A
Slide 9: Mechanical Detection Threshold Using von Frey Fibers
Mechanical Detection Threshold Using von Frey Fibers Force where Subject No Longer Feels the Fiber Lost 250 200 Sensation 150 when 100 (mN) Force 50 0 HOURS HTX-011 400 mg (n=5) Placebo (n=3) 9 *Combined placebo data from all cohorts HERON THERAPEUTICS Advancing medicine. Improving Health.
Slide 10: Pharmacodynamic Effects of HTX-011 Correlate with Pharmacokinetic Profile
Pharmacodynamic Effects of HTX-011 Correlate with Pharmacokinetic Profile 250 500 Lost 450 200 400 Plasma 350 Sensation 150 300 250 100 200 Bupviacaine 150 when(mN) 50 100 50 (ng/mL) Force 0 0 HOURS HTX-011 400 mg (n=5) Placebo (n=3) Plasma Bupivacaine Observed with HTX-011 10 *Combined placebo data
Slide 11: Safety
Safety • No serious adverse events or premature discontinuations • No clinically relevant ECG changes • No clinically relevant laboratory changes • Only adverse events considered possibly related to drug were associated with the subcutaneous administration of the product: mild redness and bruising a
Slide 12: Summary
Summary • Initial Phase 1 experience validates target product profile for HTX-011 • Desired pharmacokinetic profile for both bupivacaine and meloxicam achieved • Strong pharmacodynamic activity that correlated with pharmacokinetic profile observed – Rapid on-set of action without a large initial pea