Kedrion Biopharma Announces Completion of Enrollment for CARES10, a Phase 3, Multi-Center Study to Assess a 10 Percent Intravenous Immunoglobulin in Adults with Primary Immunodeficiency Disease

News provided by

Jan 30, 2020, 07:00 ET

FORT LEE, N.J., Jan. 30, 2020 /PRNewswire/ --

Ahead of schedule, the last patient has been enrolled in CARES10 (Clinical Assessment of phaRmacokinetics, Efficacy, Safety of a 10% Ig) the first study of a clinical candidate by Kedrion Biopharma, an international specialist in plasma-derived products used in treating rare and serious diseases.
CARES10 enrolled a total of 47 patients across 12 sites.
CARES10 is a phase 3, open-label, prospective, multi-center study to assess the pharmacokinetics, safety, and efficacy of a 10 percent intravenous immunoglobulin in primary immunodeficiency patients in the U.S. and Canada.
CARES10 is expected to be completed by Q2 2021. Pivotal data from CARES10 will be used in a biologics license application (BLA) submission to FDA.
Immunoglobulin is a widely accepted and proven treatment available for various immune disorders in a global market expected to exceed $18B by the end of 2025.

Kedrion Biopharma, an international specialist in the manufacture and distribution of plasma-derived therapeutic products used in treating rare and serious diseases, today announced that enrollment is complete in the CARES10 (Clinical Assessment of phaRmacokinetics, Efficacy, Safety of a 10% Ig) clinical study. CARES10 is a United States/Canada-based open-label, prospective, multi-center phase 3 clinical study to assess efficacy, safety and pharmacokinetics of a 10 percent intravenous immunoglobulin in the treatment of adult patients with primary immunodeficiency diseases (PI).

The last patient enrolled in CARES10 is being treated at one of the 12 sites in the study. The study is scheduled to be completed by mid-2021. A subsequent goal will be to submit a biologics license application (BLA) to the U.S. Food and Drug Administration.

"Completing enrollment in the CARES10 study is a very important milestone for Kedrion Biopharma," said Paolo Marcucci, Kedrion Biopharma chairman and chief executive officer. "With this achievement, our company has taken yet another step toward bringing patients diagnosed with primary immunodeficiency another treatment option for this rare and serious condition. We are pleased and excited to be on this journey."

Kedrion Biopharma completed enrollment in CARES10 approximately a month earlier than planned. With this clinical study, Kedrion Biopharma expands its long-term strategic focus to include entry into scientific research and development of plasma-derived therapies.

According to analysts, the global plasma-derived immunoglobulin market is expected to exceed $18B by the end of 2025. Kedrion Biopharma is one of several companies that supply immunoglobulin therapies to patients in Italy, and to patients in about 100 other locations around the world.

About Primary Immunodeficiency
Primary Immunodeficiency (PI) is an umbrella term for a group of more than 350 rare and chronic disorders in which part of the body's immune system is either missing or not functioning properly. PI disorders are not contagious. Rather, they are caused by hereditary or genetic defects. PI can affect anyone, regardless of age or gender. Approximately 250,000 people are diagnosed with PI in the United States.

About Kedrion Biopharma
Kedrion Biopharma is an international company that collects and fractionates blood plasma to produce and distribute plasma-derived therapeutic products for use in treating and preventing serious diseases, disorders and conditions such as hemophilia, primary immune system deficiencies and Rh-sensitization. Kedrion Biopharma Inc., the U.S. subsidiary of Kedrion Biopharma, is headquartered in Fort Lee, New Jersey. Kedrion Biopharma launched US operations in 2011, but the company's international roots stretch back several decades in the production of blood and plasma-derived products. Kedrion Biopharma places a high value on the welfare of those who benefit from its products, as well as on the people and the communities it serves. Additional information about Kedrion Biopharma can be found at kedrion.com and kedrion.us.

Media Contacts
Forrest McCaleb
Director, Global Communications – U.S. | Kedrion Biopharma
[email protected] | 201-582-8143

Sheila Burke
Method Health Communications
[email protected] | 484-667-6330

SOURCE Kedrion Biopharma