EXTON, PA, USA I December 7, 2015 I Morphotek®, Inc., a subsidiary of Eisai Inc., announced today results from Study MORAb-022-001, a single-dose, dose-ascending, placebo-controlled, Phase 1 trial evaluating the safety and tolerability of its investigational, anti-GM-CSF, monoclonal antibody, MORAb-022 in healthy subjects (n=26) and mild-to-moderate Rheumatoid Arthritis (RA) patients (n=25).
In this study, all of the MORAb-022 dose cohorts in the RA patients demonstrated decreases in their median 28-joint Disease Activity Score based on C-reactive protein (DAS28 (CRP)) by Day 5; however, only the highest single-dosed 10 mg/kg cohort showed a median decrease of more than 1.2 units, which is considered clinically meaningful according to the European League Against Rheumatism (EULAR). The overall incidence of Treatment Emergent Adverse Events was low, and there were no severe adverse events reported during the study for any subject. There were no Rheumatology Common Toxicity Criteria (RCTC) Grade 3 or 4 adverse events reported for subjects with RA in any dose cohort during the study. The pharmacokinetics for MORAb-022 increased approximately in a linear, dose-proportional manner.
“The responses observed with our investigational monoclonal antibody, MORAb-022, in this Phase 1 trial with mild-to-moderate RA patients are very encouraging and support further research in randomized trials to evaluate the concept of inhibiting the cytokine, GM-CSF, in the treatment of patients with RA,” stated Charles Schweizer, Ph.D., Vice President, Clinical Operations and Pharmaceutical Product Development at Morphotek. “Considering approximately one third of patients do not respond to current RA treatment, there is a need to investigate potential new treatment modalities and pathways to try to improve clinical benefit for patients.”
About MORAb-022 Clinical Development
MORAb-022 is an investigational, fully humanized monoclonal antibody (mAb) directed to human GM-CSF. GM-CSF is a cytokine that plays a role in the inflammatory immune response, and is expressed at higher levels at sites of inflammation and autoimmunity, such as in the synovial fluid of patients with RA. Study MORAb-022-001 was a Phase 1 randomized, double-blind, placebo-controlled, single-dose, dose-escalation study in healthy male or female subjects and patients with mild-to-moderate RA at investigational sites located in the United States and The Netherlands. The study was designed to assess the safety and tolerability of single escalating doses of MORAb-022 in healthy subjects before assessing the safety and tolerability in RA. Eligible subjects were randomly assigned to receive a single IV infusion of MORAb-022 or placebo on Day 1, with follow-up observation for 85 days. Cohorts of five RA patients per dose level of 0.36 mg/kg, 0.7 mg/kg, 1 mg/kg, 3 mg/kg, and 10 mg/kg were enrolled sequentially.
Further information on the clinical study can be found at www.clinicaltrials.gov, study number NCT01357759. Based on these Phase 1 results, Morphotek is currently planning a larger Phase 2 study to investigate the efficacy of MORAb-022 in mild-to-moderate RA patients.
About Morphotek
Morphotek®, Inc., a subsidiary of Eisai Inc., is a biopharmaceutical company specializing in the development of protein and antibody products through the use of a novel and proprietary gene evolution technology. The technology has been successfully applied to a broad variety of cell lines and organisms to yield genetically diverse offspring that are suitable for pharmaceutical product development in the areas of antibody therapeutics, protein therapeutics, product manufacturing, drug target discovery, and improved output traits for commercial applications. The company is currently focusing its platform on the development and manufacturing of therapeutic antibodies for the treatment of cancer, inflammation and infectious disease. For more information, please visit www.morphotek.com.
About Eisai Inc.
At Eisai Inc., human health care is our goal. We give our first thoughts to patients and their families, and helping to increase the benefits health care provides. As the U.S. pharmaceutical subsidiary of Tokyo-based Eisai Co., Ltd., we have a passionate commitment to patient care that is the driving force behind our efforts to help address unmet medical needs. We are a fully integrated pharmaceutical business with discovery, clinical, manufacturing and marketing capabilities. Our key areas of commercial focus include oncology and specialty care (Alzheimer’s disease, epilepsy and metabolic disorders). To learn more about Eisai Inc., please visit us at www.eisai.com.
Eisai Inc. has affiliates that are part of a global product creation organization that includes R&D facilities in Massachusetts, New Jersey, North Carolina and Pennsylvania, as well as a global demand chain organization that includes manufacturing facilities in Maryland and North Carolina. Eisai’s global areas of R&D focus include neuroscience; oncology; metabolic disorders; vascular, inflammatory and immunological reaction; and antibody-based programs.
SOURCE: Morphotek
Post Views: 176
EXTON, PA, USA I December 7, 2015 I Morphotek®, Inc., a subsidiary of Eisai Inc., announced today results from Study MORAb-022-001, a single-dose, dose-ascending, placebo-controlled, Phase 1 trial evaluating the safety and tolerability of its investigational, anti-GM-CSF, monoclonal antibody, MORAb-022 in healthy subjects (n=26) and mild-to-moderate Rheumatoid Arthritis (RA) patients (n=25).
In this study, all of the MORAb-022 dose cohorts in the RA patients demonstrated decreases in their median 28-joint Disease Activity Score based on C-reactive protein (DAS28 (CRP)) by Day 5; however, only the highest single-dosed 10 mg/kg cohort showed a median decrease of more than 1.2 units, which is considered clinically meaningful according to the European League Against Rheumatism (EULAR). The overall incidence of Treatment Emergent Adverse Events was low, and there were no severe adverse events reported during the study for any subject. There were no Rheumatology Common Toxicity Criteria (RCTC) Grade 3 or 4 adverse events reported for subjects with RA in any dose cohort during the study. The pharmacokinetics for MORAb-022 increased approximately in a linear, dose-proportional manner.
“The responses observed with our investigational monoclonal antibody, MORAb-022, in this Phase 1 trial with mild-to-moderate RA patients are very encouraging and support further research in randomized trials to evaluate the concept of inhibiting the cytokine, GM-CSF, in the treatment of patients with RA,” stated Charles Schweizer, Ph.D., Vice President, Clinical Operations and Pharmaceutical Product Development at Morphotek. “Considering approximately one third of patients do not respond to current RA treatment, there is a need to investigate potential new treatment modalities and pathways to try to improve clinical benefit for patients.”
About MORAb-022 Clinical Development
MORAb-022 is an investigational, fully humanized monoclonal antibody (mAb) directed to human GM-CSF. GM-CSF is a cytokine that plays a role in the inflammatory immune response, and is expressed at higher levels at sites of inflammation and autoimmunity, such as in the synovial fluid of patients with RA. Study MORAb-022-001 was a Phase 1 randomized, double-blind, placebo-controlled, single-dose, dose-escalation study in healthy male or female subjects and patients with mild-to-moderate RA at investigational sites located in the United States and The Netherlands. The study was designed to assess the safety and tolerability of single escalating doses of MORAb-022 in healthy subjects before assessing the safety and tolerability in RA. Eligible subjects were randomly assigned to receive a single IV infusion of MORAb-022 or placebo on Day 1, with follow-up observation for 85 days. Cohorts of five RA patients per dose level of 0.36 mg/kg, 0.7 mg/kg, 1 mg/kg, 3 mg/kg, and 10 mg/kg were enrolled sequentially.
Further information on the clinical study can be found at www.clinicaltrials.gov, study number NCT01357759. Based on these Phase 1 results, Morphotek is currently planning a larger Phase 2 study to investigate the efficacy of MORAb-022 in mild-to-moderate RA patients.
About Morphotek
Morphotek®, Inc., a subsidiary of Eisai Inc., is a biopharmaceutical company specializing in the development of protein and antibody products through the use of a novel and proprietary gene evolution technology. The technology has been successfully applied to a broad variety of cell lines and organisms to yield genetically diverse offspring that are suitable for pharmaceutical product development in the areas of antibody therapeutics, protein therapeutics, product manufacturing, drug target discovery, and improved output traits for commercial applications. The company is currently focusing its platform on the development and manufacturing of therapeutic antibodies for the treatment of cancer, inflammation and infectious disease. For more information, please visit www.morphotek.com.
About Eisai Inc.
At Eisai Inc., human health care is our goal. We give our first thoughts to patients and their families, and helping to increase the benefits health care provides. As the U.S. pharmaceutical subsidiary of Tokyo-based Eisai Co., Ltd., we have a passionate commitment to patient care that is the driving force behind our efforts to help address unmet medical needs. We are a fully integrated pharmaceutical business with discovery, clinical, manufacturing and marketing capabilities. Our key areas of commercial focus include oncology and specialty care (Alzheimer’s disease, epilepsy and metabolic disorders). To learn more about Eisai Inc., please visit us at www.eisai.com.
Eisai Inc. has affiliates that are part of a global product creation organization that includes R&D facilities in Massachusetts, New Jersey, North Carolina and Pennsylvania, as well as a global demand chain organization that includes manufacturing facilities in Maryland and North Carolina. Eisai’s global areas of R&D focus include neuroscience; oncology; metabolic disorders; vascular, inflammatory and immunological reaction; and antibody-based programs.
SOURCE: Morphotek
Post Views: 176
