Celon Pharma Sa · GPW:CLN
Celon Pharma Sa — Investor Day (October 2022)
13 slides from Celon Pharma Sa's investor day presentation, October 2022
Slide 1: Neuropsychiatry
Neuropsychiatry Sylwia Janowska Clinical Development Leader Celon Pharma Investor Day 2022
Slide 2: Neuropsychiatric projects
Neuropsychiatric projects CLINICAL DEVELOPMENT INDICATION MOLECULAR TARGET RESEARCH PRE-CLINICAL DEVELOPMENT PHASE | Treatment-resistance NMDAR Agonist PHASE II Schizophrenia ;
Slide 3: Esketamine DPI – Clinical Development Overview
Esketamine DPI – Clinical Development Overview Phase 1 Phase 2 TRBD 01KET2017 03KET2018 62 healthy volunteers 88 patients with TRBD PK, Safety 3 doses vs placebo SD and MD (2 weeks) Efficacy, Safety, PK MD (2 weeks) Q4 2017 – Q2 2018 Q1 2019 – Q1 2021 Q1 2019 – Q2 2020 Phase 2 TRD-MDD 02KET2018 89 p
Slide 4: Esketamine DPI – Clinical Development Overview
Esketamine DPI – Clinical Development Overview Phase 3 TRBD Phase 1 Phase 2 TRBD Phase 3 TRBD OLS study 01KET2017 03KET2018 2 acute studies 200 patients with TRBD 62 healthy volunteers 88 patients with TRBD 2 x 240 patients with TRBD Long-term Safety and Efficacy PK, Safety 3 doses vs placebo Effica
Slide 5: Esketamine DPI – Regulatory Activity Overview
Esketamine DPI – Regulatory Activity Overview EMA SA EMA SA Discussion on: Discussion on: Nonclinical and Clinical Nonclinical and Clinical development development Smart inhaler Home administration Q2 2016 Q1 2020 Q1 2020 Q2 2022 FDA preIND meeting FDA IND submission Discussion on: ‚safe to proceed’
Slide 6: Esketamine DPI – Regulatory Activity Overview
Esketamine DPI – Regulatory Activity Overview EMA SA EMA SA EMA SA Discussion on: Discussion on: Discussion on: Nonclinical and Clinical Nonclinical and Clinical Clinical development – phase 3 program development development Nonclinical development Smart inhaler CMC, Inhaler Home administration Q2 2
Slide 7: Neuropsychiatric projects
Neuropsychiatric projects CLINICAL DEVELOPMENT INDICATION MOLECULAR TARGET RESEARCH PRE-CLINICAL DEVELOPMENT PHASE | Treatment-resistance NMDAR Agonist PHASE II Schizophrenia ;
Slide 8: CPL'36 – Clinical Development Overview
CPL’36 – Clinical Development Overview Phase 1 01PDE2018 62 healthy volunteers Safety, PK SD and MD (2 weeks) Q4 2018 – Q3 2019 Abbreviations: PK = Pharmacokinetics; SD = single dose; MD = multiple dose.
Slide 9: CPL'36 – Clinical Development Overview
CPL’36 – Clinical Development Overview Phase 1 Phase 2 Schizophrenia 01PDE2018 02PDE2019 62 healthy volunteers 165 patients with acute exacerbation Safety, PK 2 doses vs placebo SD and MD (2 weeks) Efficacy, Safety, PK MD (4 weeks) Q4 2018 – Q3 2019 Q3 2020 – Q3/Q4 2023 Q3 2021 – Q3/Q4 2023 Phase 2
Slide 10: CPL'36 – Clinical Studies status
CPL’36 – Clinical Studies status Patients Schizophrenia (n=165) Randomization 1:1:1 Doses 20 mg 40 mg placebo Poland Hungary RA approval September 2020 May 2021 Number of clinical sites 3 3 Randomized patients 17 1 Abbreviations: RA = Regulatory Authorities.
Slide 11: CPL'36 – Clinical Studies status
CPL’36 – Clinical Studies status Patients Schizophrenia (n=165) Randomization 1:1:1 Doses 20 mg 40 mg placebo Poland Hungary Ukraine RA approval September 2020 May 2021 ~December 2022 Number of clinical sites 3 3 4 Randomized patients 17 1 - Estimated Recruitment Rate: 15 patients/months* (after Ukr
Slide 12: CPL'36 – Clinical Studies status
CPL’36 – Clinical Studies status Patients Patients Schizophrenia (n=165) LiD (n=108) Randomization 1:1:1 Randomization 1:1:1 Doses 20 mg 40 mg placebo Doses 20 mg 40 mg placebo Poland Hungary Ukraine Poland Ukraine RA approval September 2020 May 2021 ~December 2022 RA approval July 2021 December 202
Slide 13: Neuropsychiatry
Neuropsychiatry Sylwia Janowska Clinical Development Leader sylwia.janowska@celonpharma.com Celon Pharma Investor Day 2022