Tonix Pharmaceuticals Holding Corp. · NASDAQ:TNXP
Tonix Pharmaceuticals — American Society of Clinical Psychopharmacology Annual Meeting 2016
20 slides from Tonix Pharmaceuticals's conference presentation, May 31, 2016
Slide 1: Results from the AtEase Study
A Randomized Placebo-Controlled Multicenter Trial of a Low-Dose Bedtime Sublingual Formulation of Cyclobenzaprine (TNX-102 SL) for the Treatment of Military-Related PTSD Results from the “AtEase” Study Presented by Gregory Sullivan MD at American Society of Clinical Psychopharmacology Annual Meeting
Slide 2: Why We Studied Military PTSD
The AtEase Study Why We Studied Military PTSD 1 Characteristics of military-related PTSD population - Combat traumas but could include non-combat traumas during service (e.g. sexual assault) - Male-predominant (85:15) vs. civilian female-predominant (67:33)1 - More commonly repeated traumas during d
Slide 3: Rationale for TNX-102 SL for PTSD
The AtEase Study Rational for TNX-102 SL for PTSD 2 TNX-102 SL is a sublingual formulation of cyclobenzaprine (CBP) - Transmucosal absorption - Tricyclic molecule – not antidepressant - Targets receptors believed to play key roles in sleep physiology - functional studies show antagonism at each of1
Slide 4: Rationale for Targeting of Sleep for Treatment of PTSD
The AtEase Study Rational for Targeting of Sleep for Treatment of PTSD 3 Previous work of TNX-102 SL in a bedtime, nightly regimen improved fibromyalgia symptoms and supported a mechanism in which TNX-102 SL improved sleep quality - PTSD has clinical overlap with fibromyalgia - PTSD has comorbidity
Slide 5: Phase 2 Trial of TNX-102 SL in PTSD
The AtEase Study Phase 2 Trial of TNX-102 SL in PTSD TNX-CY-P201 Began Enrolling in 1Q 2015; Finished Enrolling in Q4 of 2015 4 TNX-102 SL at bedtime once-daily Randomized, double-blind, placebo-controlled trial in military-related PTSD 5.6 mg N = 49* N=231*; 24 U.S. clinical sites (2 VA; 2 Universi
Slide 6: Consort Diagram of TNX-CY-P201
The AtEase Study Consort Diagram of TNX-CY-P201 5 455 Patients Screened 210 Excluded - 172 Did not meet criteria - 12 Withdrew consent - 23 Lost to follow-up - 3 PI discretion 245 Randomized Safety 94 Placebo 101 TNX-102 SL 2.8 mg 50 TNX-102 SL 5.6 mg Efficacy* 92 Placebo 90 TNX-102 SL 2.8 mg 49 TNX
Slide 7: Selected Demographics and Characteristics
AtEase Study Selected Demographics and Characteristics 6 93% of the sample was male 98% had trauma during military service - Deployed an average of 2.3 times Mean time since index trauma was 7 years Race and ethnicity generally consistent with US military distribution Fibromyalgia 7% by ACR 2010 cri
Slide 8: Severity of Baseline CAPS-5 Scores
AtEase Study Severity of Baseline CAPS-5 Scores 7 CAPS-5 PTSD Severity* Score Asymptomatic/few symptoms 0 – 10 Mean CAPS-5 Mild PTSD/subthreshold 11 - 22 Score at Moderate PTSD/threshold 23 - 34 Baseline (SD) Severe PTSD symptomatology 35 - 46 39.5 (7.85) Extreme PTSD symptomatology ≥ 47 CAPS-5: 20
Slide 9: Index Traumas During Military Service
AtEase Study Index Traumas During Military Service 8 Index Traumas During Military Service Related to Dx of PTSD Patient Count (Categories with >5 Patients) Being involved in an IED explosion or suicide bombing 35 Being attacked or ambushed 33 Witnessing death or injury of fellow soldiers 30 Witness
Slide 10: CAPS-5 Total Score Mean Change from Baseline
AtEase Study Results CAPS-5 Total Score Mean Change from Baseline 9 Wk 0 Wk 2 Wk 4 Wk 6 Wk 8 Wk 10 Wk 12 0 -5 LS Mean Change Placebo -10 TNX-102 SL 2.8 mg TNX-102 SL 5.6 mg -15 * * -20 * -25 *p=0.031, comparing placebo and TNX-102 SL 5.6 mg, *p<0.05, comparing placebo and TNX-102 SL 2.8 mg, by MMRM
Slide 11: Remission Rates (CAPS-5 Score <11)
AtEase Study Results Remission Rates (CAPS-5 Score <11) 10 Remission Rates p=0.17, NS* 30.0% 26.5% 25.0% 21.1% 20.0% 16.3% 15.0% 10.0% 5.0% 0.0% Placebo TNX-102 SL 2.8 mg TNX-102 SL 5.6 mg *NS, Not significant, Logistic Regression, comparing Placebo and TNX-102 SL 5.6 mg © 2016 Tonix Pharmaceuticals
Slide 12: CAPS-5 Arousal and Reactivity Cluster Score Mean Change
AtEase Study Results CAPS-5 Arousal and Reactivity Cluster Score Mean Change 11 Wk 0 Wk 2 Wk 4 Wk 6 Wk 8 Wk 10 Wk 12 0 -1 LS Mean Change -2 Placebo -3 * TNX-102 SL 2.8 mg * TNX-102 SL 5.6 mg -4 * * -5 -6 * * -7 *p<0.05, comparing TNX-102 SL 5.6 mg to placebo, mixed-effect model repeated measures *p<
Slide 13: CAPS-5: Sleep Disturbance and Exaggerated Startle Items
AtEase Study Results CAPS-5: Sleep Disturbance and Exaggerated Startle Items 12 Sleep Disturbance Wk 0 Wk 2 Wk 4 Wk 6 Wk 8 Wk 10 Wk 12 0 -0.2 Placebo LS Mean Change -0.4 -0.6 * TNX-102 SL 2.8 mg -0.8 -1 TNX-102 SL 5.6 mg -1.2 * -1.4 * *p<0.05, TNX-102 SL 5.6 mg v. Placebo, MMRM * -1.6 * *p<0.05, TNX
Slide 14: Clinician Global Impression – Improvement Scale Responders
AtEase Study Results Clinician Global Impression – Improvement Scale Responders 13 CGI-I Responder Analysis 70% * 63.30% 60% 53.30% 50% 44.60% 40% 30% 20% 10% 0% Placebo TNX-102 SL 2.8 mg TNX-102 SL 5.6 mg *p=0.041, Logistic regression comparing placebo and TNX-102 SL 5.6 mg Responders are those rat
Slide 15: Sheehan Disability Scale – Work/School & Social/Leisure Domains
AtEase Study Results Sheehan Disability Scale – Work/School & Social/Leisure Domains 14 The symptoms have disrupted The symptoms have disrupted your work/school work your social/leisure activities Wk 0 Wk 2 Wk 4 Wk 6 Wk 8 Wk 10 Wk 12 Wk 0 Wk 2 Wk 4 Wk 6 Wk 8 Wk 10Wk 12 5.5 7.5 5 7 Placebo 6.5 Placeb
Slide 16: Adverse Events (≥5% rate in any group)
AtEase Study Results Adverse Events (≥5% rate in any group) 15 TNX-102 SL TNX-102 SL Placebo Overall Preferred Term 2.8 mg 5.6 mg N=94* N=237* N=93* N=50* Local Administration Site Conditions Hypoaesthesia oral 2 ( 2.1%) 36 (38.7%) 18 (36.0%) 54 (37.8%) Paraesthesia oral 3 ( 3.2%) 15 (16.1%) 2 ( 4.0
Slide 17: The Summary
The AtEase Study Results Summary 16 Recruited a population with severe military-related PTSD, almost exclusively combat traumas incurred during OIF/OEF/OND deployments: - Predominantly male TNX-102 SL at 5.6 mg daily at bedtime for 12 weeks: - Reduced severity of PTSD (CAPS-5, p=0.031, Effect Size=0
Slide 18: Conclusions: TNX-102 SL in Military-Related PTSD
AtEase Study Conclusions: TNX-102 SL in Military-Related PTSD 17 This is the first multicenter randomized clinical trial of any medication that has demonstrated efficacy in a population with military-related PTSD - Male predominant (93%) - Low incidence of comorbid fibromyalgia (7%) - Low incidence
Slide 19: Acknowledgements
AtEase Study Acknowledgements 18 We wish to thank the military personnel, veterans, and law enforcement officers for their participation in AtEase Tonix personnel responsible for AtEase include: - Seth Lederman, Judy Gendreau, Heather Jividen, Bruce Daugherty, Ashild Peters, Perry Peters, Ron Notves
Slide 20: Acknowledgements
AtEase Study Acknowledgements 19 Principal Investigator Institution Arnold, Lesley UNIVERSITY OF CINCINNATI COLLEGE OF MEDICINE Bari, Mohammed SYNERGY CLINICAL RESEARCH Brenner, Ronald Chueh, Daniel NEUROBEHAVIORAL RESEARCH, INC. NRC RESEARCH INSTITUTE We would also like Croft, Harry CLINICAL TRIALS