Slide 1: Significant and Clinically Important Efficacy of Evenamide Add-on to an Antipsychotic in TRS Patients
Significant and Clinically Important Efficacy of Evenamide Add-on to an Antipsychotic in TRS Patients Treated for 1-year in a Phase 2 Study P2.34 Ravi Anand, MD Anand Pharma Consulting (APC) Switzerland Ravi Anand, MD Anand Pharma Consulting (APC), Switzerland
Slide 2: Disclosures
DISCLOSURES Commercial Interest Relationship(s) Newron Pharmaceuticals Chief Medical Officer, Consultant AbbVie, Acadia, BiolineRx, Domain, Enkam, Erydel, Forest, Janssen, Hoffman La Roche, Consultant Lundbeck, Ono, Pfizer, UCB, Sigma-Tau, Takeda, Teva Ravi Anand, MD Anand Pharma Consulting (APC), S
Slide 3: Rationale for Use of Evenamide in Patients with Treatment Resistant Schizophrenia
Rationale for Use of Evenamide in Patients with Treatment Resistant Schizophrenia Combination of evenamide and an antipsychotic reverses deficits produced by glutamate antagonists • Resistance to treatment with antipsychotics (APs) occurs in ~30% of patients with schizophrenia; it is noted in up to
Slide 4: Study 014 and Study 015 (OLE) Description
Study 014 and Study 015 (OLE) Description Safety, tolerability, and preliminary efficacy of 3 fixed oral doses of evenamide • Pilot, phase II, open-label, rater-blinded, randomized, parallel-group, multi-center study in patients with TRS • Efficacy endpoints → PANSS, CGI-S, CGI-C and Strauss Carpent
Slide 5: Study 014/015 1-year results: Patient disposition and safety summary
Study 014/015 1-year results of the first 100 patients Patient disposition and safety summary Day 0 WEEK 30 WEEK 52 WEEK 6 Randomization 6-MONTH 1-YEAR Randomized N = 100 Completed N = 97 Discontinued N = 3 Completed N = 85 Completed N = 77 Entered Extension N = 90 Did not enter extension N = 7 Disc
Slide 6: Study 014/015: PANSS Total Score and Responder Rate
Study 014/015: PANSS Total Score and Responder Rate Key efficacy results PANSS Total Score - Mean (Change from Baseline [%]) PANSS Responder rate N=97; LOCF N=97; LOCF 79.7 PANSS Visit Responder Rate # * Week-6 16.5% 70.2 (-9.5) * [-11.9%] * 67.1 (-12.6) [-15.9%] 65.1 (-14.6) 6-Month 39.2% [-18.3%]
Slide 7: Study 014/015: CGI-C and CGI-S Responder Rate
Study 014/015: CGI-C and CGI-S Responder Rate Key efficacy results CGI-Change from Baseline Responder Analysis (%) CGI-S categories of change (%) N=97; LOCF N=97; LOCF 51.6 28.9 48.4 1-Year 41.2 43.3 49.5 36.1 16.5 26.8 6-Months 21.6 59.8 15.5 15.5 10.3 Week-6 48.5 Week-6 6-Month 1-Year Very much im
Slide 8: Key findings and conclusions
Study 014/015 1-Year results of the first 100 patients Key findings and conclusions • Statistically significant improvement in PANSS total score, CGI-S, and Strauss-Carpenter LOF (*p<0.001; paired t-test; LOCF) • Through 1-Year, all efficacy scales show gradually increasing and sustained improvement