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Guy W, editor. ECDEU Assessment Manual for Psychopharmacology. 1976. Rockville, MD, U.S. Department of Health, Education, and Welfare. 2. Forkmann T, et al. The clinical global impression scale and the influence of patient or staff perspective on outcome. BMC Psychiatry. 2011, 11:83. https://doi.org/10.1186/1471-244X-11-83. 3. Busner J, et al. The Clinical Global Impressions Scale.
CGI-I-AS is used to measure a patient's symptom change since starting treatment across four key clinical areas of Angelman syndrome CGI-I-AS can be used to measure clinical improvement or worsening after starting a therapy Communication Motor What is CGI-I? The Clinical Global Impression of Improvement (CGI-I) is a comprehensive measure of change in the patient's overall clinical status (improvement or worsening) since a patient started treatment.
Guy W, editor. ECDEU Assessment Manual for Psychopharmacology. 1976. Rockville, MD, U.S. Department of Health, Education, and Welfare | 2. Forkmann T, et al. The clinical global impression scale and the influence of patient or staff perspective on outcome. BMC Psychiatry. 2011, 11:83. https://doi.org/10.1186/1471-244X-11-83. Vasopressin (not currently approved) History of CGI in Pharmaceutical Development Since the inception of clinical psychopharmacology, measuring treatment effects was accomplished with validated disease specific rating scales.
Ovid Data on File. 2. National Organization for Rare Disorders. https://rarediseases.org/rare-diseases/angelman-syndrome/. Accessed June 14, 2018. 3. Margolis SS et al. Neurotherapeutics. 2015;12:641-650. 4. Flavell L. Angelman Syndrome News. https://angelmansyndromenews.com/treatments-for-angelman-syndrome/. Accessed June 11, 2018. 5. Walz NC, Baranek GT.
P314. 6Cabo R et al. Poster presented at: NORD 2017. 7Prasad A et al. Am J Med Genet A. 2018;176:1327-1334. 8Angelman Syndrome News. https://angelmansyndromenews.com/treatments-for-angelman-syndrome/. Accessed June 11, 2018. 9Margolis SS et al. Neurotherapeutics. 2015;12:641-650. 10Braam W et al. J Intellect Disabil Res. 2010;54:547-555. 11Thibert RL et al.
Nat Rev Neurol. 2016;12:584-593. 2Lozano R et al. Intractable Rare Dis Res. 2016;5:145-157. 3Didden R et al. Am J Ment Retard. 2004;109:275-284. 4Aubertin G et al. https://fragilex.org/wp-content/uploads/ 2012/08/Medications_for_Individuals_with_Fragile_X_Syndrome2012-Oct.pdf. Updated October 2012. Accessed June 21, 2018. 5Raspa M et al. Poster presented at: AAN 2018.
He can never be out of our sight for even an instant. It's too dangerous for him." Mom, 14 y/o son with AS " "I'm so tired of having to educate my daughter's doctors and teachers about Angelman Syndrome. I wish more was known about how to help these kids." Mom, 33 y/o daughter with AS " "Thank you for working with our Angels. It means a lot to know that people are working to try to learn more about Angelman and help." Father, 8 y/o daughter with AS " Treatment Paradigm: No Approved Therapy For Angelman Syndrome 81% of patients take multiple concomitant off label drugs, only addressing individual symptoms with limited success3-6 and adverse reactions specific to AS Pharmacological Treatment Unmet Need Behavior Hyperactivity: psychostimulants (methylphenidate, mixed amphetamine salts) Aggressive and disruptive behaviors: antipsychotics6,8 (risperidone, aripiprazole, quetiapine) Anxiety: buspirone and benzodiazepines7 (e.g., clobazam, clonazepam) No evidence-based studies showing efficacy in AS Adverse events specific to AS: exacerbation of other aspects of the disease2-4 such as motor functions Sleep Melatonin: commonly used -agonists (clonidine), benzodiazepines (clonazepam), and antidepressants (trazodone)1,7 Variable response, efficacy may be lost over time10, side effects must be carefully monitored2 Seizures Anti-seizure medications: valproic acid (VA), benzodiazepines (clonazepam), lamotrigine and levetiracetam1,9 multiple seizure types, often refractory to medications11, Adverse events specific to AS: exacerbation of motor functions (VA) AS=Angelman syndrome.1Buiting K et al.
Extrasynaptic GABA Signaling Mediates Tonic Inhibition-the Brain's Ability To Distinguish Signal From Noise Information Available to the Brain at Low, Optimal, and Excessive Levels of Tonic Inhibition4,5 GABA= -aminobutyric acid. 1. Brickley SG, Mody I. Neuron. 2012;73:23-34. 2. Egawa K et al. Sci Transl Med. 2012;4:163ra157. doi:10.1126/scitranslmed.3004655. 3.
Additional risks that could cause actual results to differ materially from those in the forward-looking statements are discussed in the Company's filings with the U.S. Securities and Exchange Commission, including the "Risk Factors" sections contained therein. Such risks may be amplified by the COVID-19 pandemic and its potential impact on Ovid's business and the global economy.
Factors that may cause actual results to differ materially from these forward-looking statements include the fact that initial data from clinical trials may not be indicative, and are not guarantees, of the final results of the clinical trials and are subject to the risk that one or more clinical outcomes may materially change as patient enrollment continues and or more patient data becomes available.
Each of these forward-looking statements involves risks and uncertainties. These statements are based on the Company's current expectations and projections made by management and are not guarantees of future performance. Therefore, actual events, outcomes and results may differ materially from what is expressed or forecast in such forward-looking statements.
Forward-looking statements contained in this presentation may include, but are not limited to, statements about the progress, timing, scope and the design of any future clinical trials for OV101, the progress, timing and reporting of clinical data of NEPTUNE or any future clinical trials for OV101, the progress, timing and results of any discussions with regulatory authorities regarding OV101, the potential clinical benefit of OV101, the future results of the NEPTUNE trial, the progress, timing and results of clinical trials regarding Ovid's other product candidates, the progress, timing, reporting of the ELARA open-label extension study and the Company's future financial results and financing plans.