Slide 1: Forward looking statements and other important cautions
Forward looking statements and other important cautions To the extent that statements contained in this presentation are not descriptions of historical facts regarding Trevena, Inc., they are forward-looking statements reflecting management’s current beliefs and expectations. Forward-looking stateme
Slide 2: Forward looking statements and other important cautions
Forward looking statements and other important cautions To the extent that statements contained in this presentation are not descriptions of historical facts regarding Trevena, Inc., they are forward-looking statements reflecting management's current beliefs and expectations. Forward-looking stateme
Slide 3: Oliceridine: the first Breakthrough Therapy designation for pain
Oliceridine: the first Breakthrough Therapy designation for pain 4 (1) FDA Guidance for Industry; Expedited Programs for Serious Conditions – Drugs and Biologics. May 2014. Oliceridine program: •Head-to-head comparisons to morphine throughout development •Differentiation based on breakthrough scienc
Slide 4: Oliceridine: a new mechanism of action
Oliceridine: a new mechanism of action The first µ-GPS – µ receptor G protein Pathway Selective modulator Conventional opioids Oliceridine µ-receptor µ-receptor β-arrestin pathway G protein pathway Analgesia ORAEs Analgesia ORAEs Potential for improved therapeutic window Narrow therapeutic window OR
Slide 5: Phase 3 program timing expectations
Phase 3 program timing expectations Initiate Phase udies votal cacy udies Phase 2 eting 1Q’16 2Q’16 1Q’17 2H’17 6 NDA submission Initiated multi-procedure safety study (ATHENA-1) Top-line data from P pivotal st hase 3 efficacy 3 pi effi st Held end-of-me FDA
Slide 6: End-of-Phase 2 Meeting Outcome
END-OF-PHASE 2 MEETING OUTCOME 7
Slide 7: Successful outcome for the end-of-phase meeting for the oliceridine program
Successful outcome for the end-of-phase 2 meeting for the oliceridine program • • General agreement was reached to move oliceridine in to Phase 3 General agreement was reached that the oliceridine Phase 3 program could support an approval for the target indication – Management of moderate-to-severe
Slide 8: Oliceridine Phase 3 Program Overview
OLICERIDINE PHASE 3 PROGRAM OVERVIEW 9
Slide 9: Pivotal efficacy studies to support potential approval
Pivotal efficacy studies to support potential approval • Two pivotal studies: same surgical models as in Phase 2 – – – APOLLO-1: 48 hour treatment following bunionectomy APOLLO-2: 24 hour treatment following abdominoplasty Each study will include 375 patients, 75/group • Primary endpoint: efficacy o
Slide 10: Phase 3 program dosing and administration
Phase 3 program dosing and administration • • Goal: dosing and administration labeling for as-needed dosing (bolus or PCA) APOLLO dosing: patient controlled analgesia (PCA), as in Phase 2b study – If PCA dosing does not adequately control pain, supplemental study drug can be given as often as every
Slide 11: Pivotal efficacy studies: primary endpoint
Pivotal efficacy studies: primary endpoint Same measure as Phase 2: pain intensity assessed with a visual analog scale • • Phase 3 will use a responder analysis as proposed by Trevena – Defined as >30% improvement in sum of pain intensity difference from baseline (SPID) without early discontinuation
Slide 12: Pivotal efficacy studies: secondary endpoints
Pivotal efficacy studies: secondary endpoints • Efficacy measures vs. placebo, including sum of pain intensity difference analyses and time to meaningful pain relief, to support primary analysis • Efficacy, safety, and tolerability comparisons to morphine allow demonstration of potential clinical ad
Slide 13: Hypoventilation respiratory safety burden
Hypoventilation respiratory safety burden • Respiratory safety endpoint: based on hypoventilation, a clinical assessment as in Phase 2b study • Phase 3 analysis: prevalence x duration = respiratory safety burden (RSB) – – Provides more robust assessment of respiratory safety Higher power than simple
Slide 14: Summary
Summary Successful end-of-phase 2 meeting • – – – Appropriate to move oliceridine to Phase 3 Agreed upon key elements of Phase 3 program Collaborative discussion with FDA • Phase 3 program overview – APOLLO studies designed to support approval and differentiation •Endpoints and analysis are well inf
Slide 15: Biased Ligands. Better Drugs.
Biased Ligands. Better Drugs. 16
Slide 16: Trevena
WéTrevena Biased Ligands. Better Drugs. YE Trevena 5