CRED Understanding Clinical Development 2024

08/10/2024

#2

Arm A (n=60)

SCREENING

Q2W dosing SOC

Single PE SOC

24 weeks

Arm B (n=60)

Key eligibility criteria (incl/exclu criteria) • Age (≥18 yrs) • Definition of disease • Stage of disease • Concomitant medication • Risk factor • Prior disease • Biomarker positive

Q2W dosing devostatin – Dose 1

Single PE Arm B vs Arm A

24 weeks

N=240 1:1:1:1

Arm C (n=60)

Q2W dosing devostatin – Dose 2

Single PE Arm C vs Arm A

24 weeks

Arm D (n=60)

Q2W dosing devostatin – Dose 3

Single PE Arm D vs Arm A

24 weeks

Tapering of con-med

Stratification: • Disease severity (moderate/severe) • Biomarker status (+ve/ve)

Key SE: Clinical improvement (PRO); number of AE’s; PK/PD relationship; QOL

The Organisation for Professionals in Regulatory Affairs

HEAD TO HEAD SUPERIORITY TRIAL AGAINST SOC

21

#3

Arm A (n=120)

SCREENING

Q2W dosing Placebo devostatin

Single PE Placebo

24 weeks

Arm B (n=120)

Key eligibility criteria (incl/exclu criteria) • Age (≥18 yrs) • Definition of disease • Stage of disease • Concomitant medication • Risk factor • Prior disease • Biomarker positive

Q2W dosing devostatin – Dose 1

Single PE Arm B vs Arm A

24 weeks

N=480 1:1:1:1

Arm C (n=120)

Q2W dosing devostatin – Dose 2

Single PE Arm C vs Arm A

24 weeks

Arm D (n=120)

Q2W dosing devostatin – Dose 3

Single PE Arm D vs Arm A

24 weeks

Tapering of con-med

Stratification: • Disease severity (moderate/severe) • Biomarker status (+ve/ve)

Key SE: Clinical improvement (PRO); number of AE’s; PK/PD relationship; QOL

The Organisation for Professionals in Regulatory Affairs

POTENTIALLY A REGISTRATIONAL Ph 2

22

11