Kedrion Biopharma Phase III Trial, CARES10, achieves important milestone: Last Patient Treated

FORT LEE, N.J., Jan. 4, 2021 /PRNewswire/ -- 

• Objectives of CARES10 (Clinical Assessment of phaRmacokinetics, Efficacy, Safety of a 10% Ig), a phase III, open-label, prospective, multi-center study were to assess the efficacy, safety, and pharmacokinetics of a 10 percent intravenous immunoglobulin (IVIG) in primary immunodeficiency disease (PI) patients.
• The primary efficacy endpoint of the study was to establish the incidence rate, i.e., the mean number of acute serious bacterial infections (ASBIs) per patient-year (bacterial pneumonia, bacteremia/sepsis, bacterial meningitis, visceral abscess, osteomyelitis/septic arthritis) according to pre-specified criteria.
• CARES10 secondary endpoints included clinical, laboratory and health-related quality of life (HRQoL) measures.
• CARES10 enrolled 47 patients in 11 sites across U.S.
• CARES10 results will form the basis of a biologics license application (BLA) submission to the U.S. Food and Drug Administration.
• Immunoglobulin is a widely accepted and proven treatment available for chronic inflammatory demyelinating polyneuropathy (CIDP) in adults to improve neuromuscular disability and impairment and for maintenance therapy to prevent relapse, primary humoral immunodeficiency (PI) in patients two years of age and older, and idiopathic thrombocytopenic purpura (ITP) in adults and children to raise platelet counts to prevent bleeding or to allow a patient with ITP to undergo surgery.
• The global market expected to exceed $18B by the end of 2025.

Kedrion Biopharma, an international biopharmaceutical company specialized in the manufacture and distribution of plasma-derived therapeutic products used in treating rare and serious diseases, announced that the last patient has been treated in the CARES10 (Clinical Assessment of phaRmacokinetics, Efficacy, Safety of a 10% Ig) trial. CARES10 is a phase III, open-label, prospective, multi-center study that assessed efficacy, safety, and pharmacokinetics of a 10 percent intravenous immunoglobulin (IVIG) in individuals diagnosed with primary immunodeficiency disease (PI). PI, a rare disease affecting approximately 250,000 people in the United States, is a group of disorders in which a part of the body's immune system is missing or does not function properly.

"The CARES10 trial spans a robust set of endpoints including clinical, laboratory, and health- related quality of life measures of the patients' experience with a 10 percent IVIG, an essential treatment for a rare and serious condition, primary immunodeficiency," said Novinyo Serge Amega, M.D., head of U.S. Medical Affairs at Kedrion Biopharma. "Now that all patients in CARES10 have been treated, we look forward to the analysis phase of the study."

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 other locations around the world.

About the CARES10 Trial

CARES10 (Clinical Assessment of phaRmacokinetics, Efficacy, Safety of a 10% Ig), a United States based, phase III, open-label, prospective, multi-center study, assessed efficacy, safety, and pharmacokinetics of a 10 percent intravenous immunoglobulin (IVIG) in Primary Immunodeficiency Disease (PI) patients. CARES10 enrolled 47 patients; among them, 23 participated to the pharmacokinetics evaluations for the trial.

The primary efficacy endpoint of the study was to establish the incidence rate, i.e., the mean number of acute serious bacterial infections (ASBIs) per patient-year (bacterial pneumonia, bacteremia/sepsis, bacterial meningitis, visceral abscess, osteomyelitis/septic arthritis) according to pre-specified criteria.

CARES10 secondary endpoints included clinical, laboratory and health-related quality of life measures (HRQoL).

CARES10 secondary outcomes included clinical measures such as the occurrence and duration of infections other than acute serious bacterial infections (ASBIs), fever episodes, and missed days of work/school; laboratory measures including IgG trough levels and antigen-specific IgG levels; and HRQoL measures.

All patients received an intravenous infusion of 200 – 800 mg/kg body weight of 10 percent IVIG every 21 or 28 days. Inclusion criteria included male or female patients with a confirmed diagnosis of PI. All patients received 200 to 800 mg/kg of commercially available IVIG at approximately 21-28 day intervals for at least 3 infusion cycles immediately prior to study entry. All patients enrolled in CARES10 were required to have had at least two documented IgG trough levels while receiving IVIG of greater than or equal to 6g/L obtained at two infusion cycles within 12 months prior to study.

About Primary Immunodeficiency (PI)

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^.2

About Kedrion Biopharma

Kedrion Biopharma is a leading international biopharmaceutical company that specializes in the development, production and distribution of plasma-derived therapeutic products for use in treating serious diseases, disorders and conditions such as immune system deficiencies and coagulation disorders. Kedrion has special expertise in the treatment of rare diseases and in the manufacture of hyper-immune products such as anti-hepatitis B, anti-tetanus and RhoGAM for prophylaxis against Rh sensitization and subsequent hemolytic disease of the fetus and newborn. The company operates through a fully integrated business model from the collection of plasma in its own centers in the United States and Hungary to fractionation and production in its manufacturing facilities located in Italy, Hungary and the United States. Headquartered in Castelvecchio Pascoli (Italy), Kedrion has over 2,500 employees and a commercial presence in approximately 100 countries worldwide. Kedrion 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.

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