PiaSky®: Efficacy and Safety

COMMODORE 2 (Phase 3 Trial)

PiaSky^® demonstrated noninferiority vs eculizumab for both hemolysis control and transfusion avoidance in treatment-naïve patients from baseline through week 25^1,3

COMMODORE 2 Co-Primary Endpoints^1,3

Similar hemolysis control with Q4W SC PiaSky^® compared to Q2W IV SoC^1,3

COMMODORE 2 Secondary Endpoints^1,3

PiaSky^® may help people with PNH achieve normalized fatigue levels¹

People treated with PiaSky^® saw greater improvements in FACIT-Fatigue scores, bringing them to within ‘normal’ population levels¹

PiaSky^® has a comparable safety profile to other C5 inhibitors^1,4,5

AE rates across the PiaSky^® population were similar to the eculizumab population^1,4,5

Pooled safety data from across the COMMODORE programme 
(includes both C5i-naïve and C5i-experienced patients)

COMMODORE 2 assessed efficacy and safety of PiaSky^® vs eculizumab in treatment-naïve patients with PNH¹

Phase III COMMODORE 2: Evaluating the noninferiority of PiaSky^® vs eculizumab in C5i-naïve patients with PNH¹

**Patients starting PiaSky^® will receive an initial weight-based loading dose through IV infusion, administered by their healthcare provider. Four subsequent loading doses are then given weekly by subcutaneous injection. Weight-based maintenance dosing is then administered once every 4 weeks subcutaneously. Patients may self-inject after receiving training from their healthcare provider.

C5 = complement protein 5; FACIT-Fatigue = Functional Assessment of Chronic Illness Therapy Fatigue; IVH = intravascular hemolysis; LDH = lactate dehydrogenase; NIM = noninferiority margin; PNH = paroxysmal nocturnal hemoglobinuria; TICR = transient immune complex reactions; ULN = upper limit of normal.