Ovid Therapeutics Inc. · NASDAQ:OVID
Ovid Therapeutics — 65th American Academy of Child & Adolescent Psychiatry (AACAP) Annual Meeting 2018
28 slides from Ovid Therapeutics's conference presentation, Oct 25, 2018
Slide 1: Presentation of Additional Data from Phase 2 STARS Trial with OV101 for Angelman Syndrome
Presentation of Additional Data from Phase 2 STARS Trial with OV101 for the Treatment of Angelman Syndrome 65th American Academy of Child & Adolescent Psychiatry (AACAP) Annual Meeting October 25, 2018 Exhibit 99.2
Slide 2: Agenda
Agenda SPEAKERS AGENDA ITEM Lora Pike Investor Relations & Public Relations Welcome Jeremy Levin, DPhil, MB BChir Chairman & CEO OV101 and Angelman syndrome Alex Kolevzon, MD Professor of Psychiatry and Pediatrics, Icahn School of Medicine at Mount Sinai Phase 2 STARS data presented at AACAP Jeremy
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 "may," "will," "expect," "plan," "anticipate" and similar expressions (as well as other words or expressions referencing future e
Slide 4: OV101 and Angelman Syndrome
OV101 and Angelman Syndrome Jeremy Levin, DPhil, MB BChir Chairman & CEO
Slide 5: Imagine if your child could not walk or speak
“Imagine if your child, or a loved one, could not walk or speak and had motor impairment, debilitating seizures and a sleep disorder. This is life today for many people living with Angelman syndrome.”
Slide 6: Angelman Syndrome: Significant Unmet Need
Condition first described in 19651 Genetic disorder with core disruptions in behavior, motor, sleep and cognitive function No approved therapies targeting core disruptions; treatment limited to supportive care No industry-sponsored trials ever conducted in Angelman syndrome prior to STARS Lifelong d
Slide 7: STARS Clinical Trial Design and Baseline Characteristics
STARS Clinical Trial Design and Baseline Characteristics Alex Kolevzon, MD Professor of Psychiatry and Pediatrics, Icahn School of Medicine at Mount Sinai
Slide 8: Reduced GABA Levels Lead to Loss of Tonic Inhibition in Angelman Syndrome Models
Decreased tonic inhibition causes the brain to become inundated with excitatory signals resulting in a wide range of symptoms Increased GABA reuptake Increased GAT1 GAT1 does not get ‘tagged’ Reduced GABA Levels Lead to Loss of Tonic Inhibition in Angelman Syndrome Models UBE3A deficiency Decreased
Slide 9: STARS is the First Industry-Sponsored Clinical Trial in Angelman Syndrome
STARS is the First Industry-Sponsored Clinical Trial in Angelman Syndrome * Excluding, poorly controlled seizure activity, concomitant use of minocycline, levodopa, zolpidem, zaleplon, eszopiclone, ramelteon, or cannabinoid derivatives or any other investigational agent, device, and/or procedure. ;
Slide 10: STARS Utilized Currently Available Scales to Assess Multiple Domains
STARS Utilized Currently Available Scales to Assess Multiple, Relevant Domains in Angelman Syndrome Domain Exploratory Endpoint Assessments Overall clinical change Clinical Global Impressions-Improvement (CGI-I): Symptoms Overall Clinical Impression of 9 Domains: Sleep, Gross Motor Ability, Fine Mot
Slide 11: Patients were Randomized Across OV101 and Placebo Arms
88 Patients were Randomized Across OV101 and Placebo Arms OV101 was used as an add-on to stable concomitant medications Screened (n=98) Randomized (n=88) Completed (n=78) Screen failures (n=10) Drop-outs (n=10) *All subjects who received at least one dose of study drug. †Full Analysis Set (FAS or mI
Slide 12: Primary Endpoint Results: Safety and Tolerability
Primary Endpoint Results: Safety and Tolerability Alex Kolevzon, MD
Slide 13: OV101 Achieved the Primary Endpoint of Safety and Tolerability
Four discontinued due to AEs (placebo, n=1 (irritability), QD, no discontinuations, BID, n=3 (myoclonus, seizure, irritability/anxiety/sleep disorder) At least one treatment-emergent AE: placebo (25/29 – 86.2%), 15 mg QD (27/29 --93.1%) and BID (25/29 – 86.2%) There were no deaths across OV101 and p
Slide 14: Exploratory Endpoints: Efficacy Results
Exploratory Endpoints: Efficacy Results Alex Kolevzon, MD
Slide 15: CGI-I is a Common Outcome Measure to Assess Overall Clinical Symptomatology
CGI-I Established, validated, physician-reported measure Used in neurology and psychiatry trials Captures totality of symptoms, including improvement in global neurological deficit Currently, no existing AS-specific scales or assessment instruments CGI-I was chosen as primary prespecified efficacy e
Slide 16: Changes in Sleep and Motor Contributed to Improvement in CGI-I
STARS Data Suggest Changes in Sleep and Motor Contributed to the Statistically Significant Improvement in CGI-I Global Improvement CGI-I Sleep Actigraphy Clinical Impression -sleep Motor Bayley PEDI-CAT CHAQ Zeno™ Walkway Exploratory Endpoints: Observed Changes CGI-I symptoms overall (MMRM1) = p=0.0
Slide 17: OV101 Reached Statistical Significance in CGI-I at Week 12
Response Based on CGI-I Symptoms Overall and Clinical Impression of 9 Domains at Week 12* OV101 Reached Statistical Significance in CGI-I at Week 12 27.4% difference p=0.0206 66.7% 39.3% Based on Fisher’s exact test responder analysis. CGI-I=Clinical Global Impressions – Improvement A subject is def
Slide 18: OV101 15mg QD Showed Statistical Significance in CGI-I Symptoms Overall
These data provide supportive rationale for OV101 15 mg QD as an efficacious dose in AS OV101 15mg QD Dose Showed Statistical Significance in CGI-I Symptoms Overall Scores Compared with Placebo Based on Mixed Model Repeated Measures (MMRM) analysis including fixed effects for visit, treatment, age (
Slide 19: Patients on OV101 QD Showed Greater Changes in CGI-I at Week 12
Patients Receiving OV101 15 mg QD Showed Greater Changes in CGI-I Symptoms Overall at Week 12 Compared with Placebo CGI-I=Clinical Global Impressions – Improvement. CGI-I Symptoms Overall at Week 12 Patients in each CGI-I score category (%)
Slide 20: CGI-I Domain Results: OV101 QD and BID vs Placebo
OV101 BID LS mean difference (SE) OV101 QD (n=27) vs Placebo (n=27) OV101 BID (n=28) vs Placebo (n=27) Sleep -0.77 (0.307) (p=0.0141)* -0.45 (0.305) (p=0.1407) Gross Motor Ability -0.26 (0.180) 0.19 (0.178) Fine Motor Ability -0.07 (0.173) 0.16 (0.172) Irritability, Agitation, and Crying -0.03 (0.19
Slide 21: Sleep Domain: Improvements Observed in Several Sleep Parameters
Sleep Domain: Improvements Observed in Several Sleep Parameters at Week 12 as Measured by Actigraphy Watch (MMRM) OV101 15mg QD dose reduced latency to sleep onset compared to placebo (n=11/27, Diff=-25.7 minutes, p=0.0147). OV101 BID compared to placebo did not have an impact on latency to sleep on
Slide 22: Motor Domain: Changes Noted in BSID-III, PEDI-CAT, CHAQ, and Zeno Walkway
Motor Domain: Changes Noted in BSID-III, PEDI-CAT, CHAQ, and Zeno™ Walk Way BSID: changes in overall motor response (54%, p=0.0889) and gross motor (36% p=0.0522) in QD dose compared to placebo PEDI-CAT: mobility score (p=0.0935), daily activity score (p=0.1170) CHAQ: (p=0.0704) in the Disability In
Slide 23: STARS Phase 2 Trial: Summary and Conclusions
STARS Phase 2 Trial : Summary and Conclusions STARS achieved primary endpoint of safety and tolerability OV101 was well-tolerated with an overall favorable safety profile Global function Statistically Significant improvement in CGI-I in the OV101 QD treatment group Sleep Reduction in sleep onset lat
Slide 24: Next Steps and Closing Remarks
Next Steps and Closing Remarks Jeremy Levin, DPhil, MB BChir Chairman & CEO
Slide 25: OV101's Development in Angelman Syndrome
OV101’s Development in Angelman Syndrome Additional Trials Expect to initiate Angelman syndrome open-label extension study (ELARA) in Q4 2018 Regulatory Dialogue Expect to meet with the FDA by the end of the year; will provide update on next steps for OV101’s development after the Agency’s official
Slide 26: 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
Slide 27: Thank you to patients, families, caregivers, and clinicians
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 28: Question & Answer Session
Question & Answer Session Jeremy Levin, DPhil, MB BChir Chairman & CEO Alex Kolevzon, MD Professor of Psychiatry and Pediatrics, Icahn School of Medicine at Mount Sinai Amit Rakhit, MD, MBA Chief Medical & Portfolio Management Officer