Ovid Therapeutics Inc. · NASDAQ:OVID
Ovid Therapeutics — Technical Presentation (August 2018)
22 slides from Ovid Therapeutics's technical presentation, Aug 6, 2018
Slide 1: Phase 2 STARS Trial Achieves Primary Endpoint and Shows Statistically Significant Improvements in CGI-I
Phase 2 STARS Trial Achieves Primary Endpoint and Shows Statistically Significant Improvements in CGI-I August 6, 2018 Exhibit 99.1
Slide 2: Agenda
Agenda SPEAKERS AGENDA ITEM Lora Pike Senior Director, IR & PR Welcome Jeremy Levin, DPhil, MB BChir Chairman & CEO Initial Remarks and OV101 Program Strategy Amit Rakhit, MD, MBA Chief Medical & Portfolio Management Officer Overview of topline STARS data Jeremy Levin, DPhil, MB BChir Chairman & CEO
Slide 3: Forward-Looking Statements
Forward-Looking Statements This presentation contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as “expects,” “anticipates,” “projects,” “estimates,” “intends,” “plans,” “believes,” variations of such words and similar expressio
Slide 4: Key Takeaways
Key Takeaways STARS is the first study to show a positive clinical impact on people with Angelman syndrome since the disorder was characterized > 50 years ago. STARS was an international, randomized, double-blind, placebo-controlled study that utilized prespecified endpoints. The trial met its prima
Slide 5: Angelman Syndrome: Significant Unmet Need
Genetic disorder with core disruptions in behavior, motor, sleep and cognitive function No FDA-approved therapies; treatment limited to supportive care Lifelong disorder that presents early in childhood 1/15,000 prevalence in the general population ~16,000-27,000 patients in the US Monogenetic disor
Slide 6: OV101: First-in-Class GABAA Receptor Agonist with Potential to Restore Tonic Inhibition
1Meera et al., J Neurophysiol. 2011; 2Belelli et al., J. Neurosci.2005; 3Olmos-Serrano et al. J. Neurosci. 2010; 4Egawa et al. Sci. Trans. Med. 2012; 5Olmos-Serrano et al. Dev. Neuro. 2011 Only δ-selective, extrasynaptic GABAA receptor agonist in clinical development Distinct from GABA allosteric mo
Slide 7: Genetic Causes of Angelman Syndrome Disrupt GABA Signaling and Result in Impaired Tonic Inhibition
Genetic Causes of Angelman Syndrome Disrupt GABA Signaling and Result in Impaired Tonic Inhibition AS=Angelman syndrome; GABA=γ-aminobutyric acid; UBE3A=ubiquitin-protein ligase E3A. 1. Buiting K et al. Nat Rev Neurol. 2016;12:584-593. 2. ASF Facts about Angelman Syndrome 2009. 3. Egawa K et al. Sci
Slide 8: STARS Objectives & Data
STARS Objectives & Data Main objective of the Phase 2 STARS trial was to provide clear insights into the safety and tolerability of OV101 in patients with Angelman syndrome. We achieved this objective. The second goal of the trial was to provide us with learnings on OV101’s ability to restore tonic
Slide 9: STARS: First Industry-Sponsored Clinical Trial in Angelman Syndrome
STARS: First Industry-Sponsored Clinical Trial in Angelman Syndrome Placebo (placebo morning, placebo night) OV101 Twice Daily (10mg morning, 15mg night) OV101 Once Daily (placebo morning, 15mg night) Assessment Points (weeks) -2 0 6 12 Screening Baseline & Randomize (1:1:1) Study Design: Phase 2, m
Slide 10: Patient Disposition
Placebo OV101 QD OV101 BID Combined OV101 All subjects No. of Subjects Screened 98 No. of Subjects Randomized (Intent to Treat Set, ITT) 29 (100.0) 29 (100.0) 30 (100.0) 59 (100.0) 88 (100.0) Safety Set* 29 (100.0) 29 (100.0) 29 ( 96.7) 58 (98.3) 87 (98.9) Full Analysis Set or modified Intent to Tre
Slide 11: Baseline Demographics and Characteristics
† Data presented are from Full Analysis Set. This set includes all subjects who were randomized and received at least one dose of study drug. * Several subjects identified with multiple race groups Characteristic† Placebo (n=29) OV101 QD (n=29) OV101 BID (n=29) Combined OV101 (n=58) All subjects (n=
Slide 12: Summary of Safety and Tolerability Findings
OV101 achieved primary endpoint of safety and tolerability as measured by incidence of AEs Overall favorable risk profile and well tolerated Similar incidence of AEs across all treatment arms with majority of AEs being mild Treatment discontinuations due to AEs were low (n=1 placebo, n=0 OV101 QD, n
Slide 13: Treatment-Emergent Adverse Events
*Descriptive data; **Drug-related TEAEs (n=4 subjects): Placebo - 1 irritability; BID – 1 seizure, 1 myoclonus, 1 irritability/anxiety/sleep disorder: ***SAEs (n=2 subjects):, worsening seizure (OV101 QD, Not Related), worsening seizure (OV101 BID, Possibly Related) Incidence n (%)* Placebo n = 29 O
Slide 14: Summary of Efficacy Findings
Efficacy endpoints were pre-specified in a statistical analysis Assessments included CGI-I, ADAMS, ABC, Sleep diary, and mPOMA-G Statistically significant difference in CGI-I (first, pre-specified efficacy measurement) at 12 weeks: Percent improvement between OV101 combined treatment arms (66.7%) vs
Slide 15: OV101 Shows Statistically Significant Improvement in CGI-I Endpoint
Placebo OV101 QD OV101 BID Combined OV101 Week 6 (n) 27 27 27 54 Mean 3.60 3.35 3.54 3.45 Week 12 (n) 27 27 28 55 Mean 3.79 3.00 3.58 3.29 p-value Week 12 0.0006 0.3446 0.0103 OV101 Shows Statistically Significant Improvement in CGI-I Endpoint *Based on Mixed Model Repeated Measures analysis adjusti
Slide 16: Patients in QD Group Showed Greater Improvement in CGI-I at Week 12 Compared to Placebo Group
Patients in QD Group Showed Greater Improvement in CGI-I at Week 12 Compared to Placebo Group Patients in each CGI-I score category (%)
Slide 17: CGI-I: Trend to Greater Numerical Response in Younger Age in QD Arm (Post-hoc)
CGI-I: Trend to Greater Numerical Response in Younger Age in QD Arm (Post-hoc) Patients with CGI-I scale of ≤3 were considered improved at week 12 Younger patients receiving single daily dose showed greatest response Trend towards increasing overall response (vs placebo) with younger age Age Placebo
Slide 18: CGI-I: Score of 'Much Improved' on QD Arm Greater in Younger Ages (Post-hoc)
CGI-I: Score of ‘Much Improved’ on QD Arm Greater in Younger Ages (Post-hoc) CGI-I clinician assessment of ‘much improved’ (Score = 2) was greater in younger ages Data consistent with hypothesis that younger patients have greater treatment effect compared to older age groups Trend towards increasing
Slide 19: Change From Baseline at Week 12 in Measures That Did Not Reach Statistical Significance
Change From Baseline at Week 12 in Measures That Did Not Reach Statistical Significance Combined OV101 P-value ADAMS / ABC (caregiver recorded) 1.0000 Sleep diary (caregiver recorded) Total sleep time at night (hrs.) 0.4420 Number of night awakenings 0.2597 Daytime sleepiness (min) 0.6978 mPOMA-G (i
Slide 20: STARS Data Executive Summary
STARS Data Executive Summary STARS is the first industry-sponsored interventional clinical trial in Angelman syndrome Safety: Overall favorable risk profile and well tolerated Efficacy and Dosing: Consistent, statistically significant improvement in the key, pre-specified endpoint of CGI-I in QD and
Slide 21: Acknowledgements
Acknowledgements Ovid Therapeutics would like to thank the patients, families, caregivers, and clinicians for their support and active involvement in the STARS clinical trial program
Slide 22: 2018 Key Pipeline Milestones: A Year of Execution and Data Readouts
*Also known as TAK-935. Co-development program with Takeda Pharmaceutical Company Limited pursuant to a license and collaboration agreement ** Preclinical data suggest potential for use of OV329 in a variety of treatment-resistant epilepsies 2018 Key Pipeline Milestones: A Year of Execution and Data
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