Sobi to present new data in both PNH and ITP at the 2022 EHA congress

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Sobi® will present new data at the hybrid EHA (European Haematology Association) congress taking place in Vienna from 9-17 June 2022, highlighting the company’s commitment in rare haematological diseases. Several analyses from the PRINCE phase 3 study with Aspaveli®/Empaveli®(pegcetacoplan) in treatment-naïve patients with paroxysmal nocturnal haemoglobinuria (PNH) will be presented looking at haematologic response and quality of life measures in this patient population, as well as data on D-dimer normalisation and effect on thrombosis following treatment, further building on the safety profile.

 

“We look forward to presenting further analyses from the PRINCE study of Aspaveli/Empaveli in treatment-naïve patients with PNH, data adding to the body of evidence in both safety and efficacy for this novel medicine,” said Anders Ullman, Head of Research & Development and Chief Medical Officer. ”We are committed to raising the standard of care in rare haematological diseases and excited to again connect in person and online with everyone joining this year's EHA congress.”

 

Key data to be presented at the EHA congress 2022

 

Paroxysmal nocturnal haemoglobinuria

 

Aspaveli®/Empaveli® (pegcetacoplan)

Effect of pegcetacoplan on quality of life in complement-inhibitor naïve patients with paroxysmal nocturnal hemoglobinuria from the phase 3 PRINCE study.

#S303

Saturday 11 June, 11:30-12:45.

Oral presentation.

 

Patients with paroxysmal nocturnal hemoglobinuria treated with pegcetacoplan show improvements in D-dimer normalization and decrease in incidence of thrombosis.

#P839

Friday 10 June, 16:30-17:45.

Poster presentation.

 

Pegcetacoplan rapidly stabilizes complement inhibitor naïve patients with paroxysmal nocturnal hemoglobinuria experiences hemolysis with acute hemoglobin decrease, PRINCE trial post hoc analysis.

#P838

Friday 10 June, 16:30-17:45.

Poster presentation.

 

A matching adjusted indirect comparison of the efficacy of pegcetacoplan using PRINCE trial data versus ravulizumab and eculizumab in complement naïve patients with paroxysmal nocturnal hemoglobinuria.

#P840

10 June, 16:30-17:45.

Poster presentation.

 

Normalization of hematologic and health-related quality of life markers in patients with paroxysmal nocturnal hemoglobinuria treated with pegcetacoplan and baseline hemoglobin at or above 10 g/dL.

#P828

Friday 10 June, 16:30-17:45.

Poster presentation.

 

A real-world analysis of healthcare resource utilization among patients with paroxysmal nocturnal hemoglobinuria who received treatment with ravulizumab.

#P1747

Friday 10 June, 16:30-17:45

Poster presentation.

 

Categorizing hematological response to pegcetacoplan in patients with paroxysmal nocturnal hemoglobinuria. A post hoc analysis of the phase 3 PRINCE study data.

#P833

Friday 10 June, 16:30-17:45

Poster presentation.

 

Immune thrombocytopenia

 

Doptelet®(avatrombopag)

Patient preferences and experiences regarding thrombopoietin-receptor agonists for immune thrombocytopenia in the Netherlands (TRAPeze NL study).

#P1636

Friday 10 June, 16:30 - 17:45

Poster presentation.

 

About Doptelet®

Doptelet (avatrombopag) is an orally administered thrombopoietin receptor agonist (TPO-RA) that mimics the biologic effects of TPO in stimulating the development and maturation of megakaryocytes, resulting in increased platelet count. It is approved in the European Union and in the United States for the treatment of severe thrombocytopenia in adult patients with chronic liver disease who are scheduled to undergo an invasive procedure, and for the treatment of thrombocytopenia in adult patients with primary chronic immune thrombocytopenia (ITP) who have had an insufficient response to a previous treatment. Chronic ITP is a rare autoimmune bleeding disorder characterised by low number of platelets. The incidence of primary ITP in adults is 3.3/100,000 adults per year with a prevalence of 9.5 per 100,000 adults1.

 

About Aspaveli®/ Empaveli®

Aspaveli/Empaveli (pegcetacoplan) is a targeted C3 therapy designed to regulate excessive activation of the complement cascade, part of the body’s immune system, which can lead to the onset and progression of many serious diseases. Aspaveli/Empaveli is approved for the treatment of paroxysmal (PNH) in the European Union and the United Kingdom as Aspaveli and in the United States, Australia, and Saudi Arabia as Empaveli. Aspaveli/Empaveli is also under investigation for several other rare diseases across haematology, nephrology, and neurology.

 

About the Sobi and Apellis collaboration

Sobi and Apellis have global co-development rights for systemic pegcetacoplan. Sobi has exclusive ex-US commercialisation rights for systemic pegcetacoplan, and Apellis has exclusive US commercialisation rights for systemic pegcetacoplan and retains worldwide commercial rights for ophthalmological pegcetacoplan, including for geographic atrophy (GA).

 

References

1. Lambert et al. Blood 2017.

 

Sobi®

Sobi is a specialised international biopharmaceutical company transforming the lives of people with rare diseases. Providing sustainable access to innovative medicines in the areas of haematology, immunology, and specialty care, Sobi has approximately 1,600 employees across Europe, North America, the Middle East, and Asia. In 2021, revenue amounted to SEK 15.5 billion. Sobi’s share (STO:SOBI) is listed on Nasdaq Stockholm. More about Sobi at sobi.com, LinkedIn and YouTube.

 

Contacts

For details on how to contact the Sobi Investor Relations Team, please click here. For Sobi Media contacts, click here.

Swedish Orphan Biovitrum AB (publ)
Postal address SE-112 76 Stockholm, Sweden
Phone: 46 8 697 20 00     www.sobi.com