Genomind and The Genecept Assay

Transcription

1 Genomind and The Genecept Assay

2 A Growing Problem of Psychiatric Conditions One in four adults, approximately 61.5 M American adults suffer from mental illness 1 ; depression will become the largest health burden worldwide by In 2006, total direct expenditures for mental health care services totaled $57.5 B. This places mental health care expenditures as the third most costly medical condition, behind heart conditions and trauma, and tied with cancer million prescriptions written for depression, costing $12 billion in Psychiatric conditions are the most frequent cause of years lived with disability (YLDs) 5 1. NAMI Facts and Numbers 2013; 2. WHO 2011; 3. NIMH 2006; 4. SAMHSA Horton et al 2010.

3 Treatment Resistance in Psychiatry Diagnosis Initial Remission Rate Treatment Resistant/Relapse Depression (MDD) % (STAR-D) 30% treatment resistant following 4 treatments Bipolar Disorder (BD) % (STEP-BD) 50-70% relapse rates Schizophrenia 3, % (CATIE) Up to 74% discontinue medications due to lack of efficacy or poor side effects after 18 months Anxiety (GAD) 5, % Recurrence in up to 50% Obsessive Compulsive 25-71% Up to 80% in 10 year Disorder (OCD) 7,8 follow-up 30-80% of psychiatric patients have unresolved symptoms. Many have abandoned drug therapy due to inefficacy or side effects 1) STAR-D: NIMH 2) STEP-BD: NIMH 3) Perry et al. Randomised controlled trial of efficacy of teaching patients with bipolar disorder to identify early symptoms of relapse and obtain treatment. BMJ 1999;318:149. dx.doi.org/ /bmj ) CATIE:NIMH 5) Angst et al. Eur Arch Psychiatry Clin Neurosci Feb;259(1): doi: /s ) Yonkers et al. Phenomenology and course of generalised anxiety disorder /bjp March ) Simpson et al. Response versus remission in obsessive-compulsive disorder. JClin Psychiatry Feb;67(2): ) Deborah Cowley, MD. Long-Term Outcomes Are Poor in Obsessive-Compulsive Disorder. reviewing Bloch MH et al. Depress Anxiety 2013 Mar 26

4 Traditional Trial and Error Treatment of Mental Illness Traditional Treatment Path of Mental Illness Traditional treatment consists of: Multiple treatment failures Intolerable side effects Diminished quality of life Lack of compliance due to disillusionment with care Data on file. Genomind 2016.

5 Pharmacogenetic Testing in Psychiatry Identification of gene variations that are associated with: Poor or adverse medication response Altered serum levels Increased efficacy Treatment regimen can be tailored to these genetic variations Reduction in lost time, frustration, and economic burden associated with multiple treatment failures Safe and Effective Safe but Not Effective Not Safe and Not Effective Not Safe but Effective Data on file. Genomind 2016.

6 Data on file. Genomind 2016.

7 Pharmacodynamic The Genecept Assay The Genecept Assay was introduced commercially in 2010: Patented gene-based assay informs treatment decisions for patients with mental health conditions, such as; depression, anxiety, obsessive-compulsive disorder (OCD), attention deficit hyperactivity disorder (ADHD), bipolar disorder, post traumatic stress disorder (PTSD), autism, schizophrenia, chronic pain and substance abuse Analyzes neurotransmitter based genes, including serotonin, dopamine, and glutamate Analyzes pharmacokinetic genes, related to drug and nutritional metabolism Over 60,000 patients have been tested in the U.S. to date Over 3,000 clinicians have ordered the test for their patients to date Clinicians are using the Assay as a standard of care in their practices Clinicians initially used the Assay for more treatment-resistant patients; however, the number of patients tested with no previous treatment trials has doubled since launch Data on file. Genomind 2016.

8 18 Genes Analyzed Data on file. Genomind 2016.

9 The Genecept Assay How it Works Results of the test, combined with expert clinical consultations, enable better patient responses to treatment Patients provide cheek swab via a collection kit supplied by Genomind Prepaid overnight shipping packet and barcoded requisition form provided so patient sample can be sent securely to Genomind s lab Genomind s CLIA-certified lab performs test with 3-5 day turnaround time 4 5 Genomind-certified A patented algorithm results physicians and PharmD s in online analytical report delivered to clinician to available to discuss results inform treatment decisions with treating clinicians via telephonic consult

10 Pharmacokinetic Genes Gene variants associated with altered liver enzyme metabolism activity may lead to side effects and toxicity PM IM EM UM Poor metabolizers or inhibitors of P450 may have increased drug serum levels and adverse events. Intermediate metabolizers or inhibitors of P450 may have IM increased drug serum levels and adverse events. Extensive metabolizers metabolize substrates normally. Ultra-rapid metabolizers or inducers of P450 may have reduced drug serum levels and poor efficacy. FDA warning (Aug 2011): Citalopram maximum dose of 20mg in CYP2C19 poor metabolizers and those receiving CYP2C19 inhibitors Swen et al 2011; 10

11 11 Pharmacodynamic Example: MTHFR Papakostas et al., 2012 Methylfolate is a beneficial augmentation to SSRIs

12 Genecept Assay Disrupts the Traditional Clinical Pathway to Treat Depression Traditional Treatment Path of Mental Illness Treatment with Genecept Assay 2 1. Data on file. Genomind Brennan FX et al. Primary Care Companion CNS Disorders. 2015;17(2).

13 Show Me the Data: Effectiveness of the Genecept Assay

14 Evidence Base of the Genecept Assay Inclusion of genes in the panel is supported by strong peer reviewed literature Genomind s clinical team, working closely with our SAB, assesses the strength of the data Genes were selected based on the critical examination of hundreds of studies showing that variations in these genes can inform treatment decisions Report content is fully cited, with 200 references to date Genomind has developed a full Literature Summary, summarizing each citation related to the genetic variations analyzed Data on file. Genomind 2016.

15 Resource Utilization Study Design: Retrospective claims review of patients who utilized the Genecept Assay, compared to propensity-scored matched controls Partnership with IMS Health, the foremost provider of healthcare information N = 333 (resource utilization) and 681 (med adherence) Findings: 9.5% relative cost savings 6% greater medication adherence in Genecept Assay treatmentguided patients, as compared to matched controls This study was peer reviewed and published in the American Journal of Managed Care (Fagerness J et al. Pharmacogenetic-Guided Psychiatric Intervention Associated With Increased Adherence and Cost Savings. American Journal of Managed Care. 2014;20(5):e146-e156.) Fagerness et al 2014.

16 The Genomind Prospective Naturalistic Open Label Study Open Label captured real world outcomes data to estimate test value for Patients and Clinicians 3 month prospective study of the effectiveness of Assay-guided treatment Data collected related to 685 patients Clinician and patient-reported outcomes data collected online Using the Genecept Assay, assessed which genetic information is most informative for clinician decision-making Relationship of genetic variants to diagnosis, medication response, adverse events, and lifestyle management IRB approved: see (NCT ) This study was peer reviewed and published in the Primary Care Companion CNS Disorders (Brennan et al 2015;17(2)). Brennan et al 2014.

17 Percent Responders Response Rates with Genecept Exceed Seminal STAR*D Trial On average, 65% of patients across all levels of treatment resistance show a clinically significant response % Response Rates by Treatment Trials 59% Level 1 (N=3,671/93) STAR*D 29% 55% Level 2 (N=1,439/103) Genecept- Clinician Reported 69% 17% 16% Level 3 (N=390/94) 66% Level 4 (N=123/79) 75% 4 Failed Trials (N=N/A/75) 56% 5 + Failed Trials (N=N/A/181) Levels indicate either stages of treatment in STAR*D or number of previously failed adequate treatment trials, with level 1 indicating zero previous treatment trials Response measured by 50% reduction in QIDS-SR16 (STAR*D) or CGI-I of 1 or 2 (Genecept-Clinician Reported) Data on file. Genomind 2015.

18 % PM or IM Antidepressant Adverse Events Case Control Study Objective: Assess association between pharmacogenetics and increased adverse effects or lack of response to certain antidepressants whose metabolism is highly dependent on CYP450 Case Control, Retrospective Observational Study, Target N = 100 Percentage of Patients by CYP Phenotype (N=50) Cases (History of Adverse Events) 57.1% Controls (Non-response) Percentage of PMs/IMS by History of Severe Adverse Events 52.9% 69.2% 17.2% 14.3% 27.6% 24.2% PM or IM UM Number of Historical Severe Adverse Events Mago et al, [data in submission].

19 Discover the Genecept Assay