Biotie reported that it has successfully completed a clinical trial with its fully human VAP-1 monoclonal antibody (BTT-1023) in rheumatoid arthritis patients
Turku, Finland | January 19, 2010 | Biotie today reported that it has successfully completed a clinical trial with its fully human VAP-1 monoclonal antibody (BTT-1023) in rheumatoid arthritis patients.
The study evaluated the safety, tolerability, and pharmacokinetics of repeated doses of intravenously administered antibody in 24 rheumatoid arthritis patients with an inadequate treatment response to methotrexate. The antibody, administered at repeated doses of up to 8 mg/kg in combination with methotrexate, was generally well tolerated, and no serious or severe adverse events were reported in the study subjects. The pharmacokinetic characteristics of BTT-1023 are consistent with those expected for an intravenously administered monoclonal antibody intended for chronic conditions.
The study was not designed to enable formal statistical evaluation of therapeutic activity. However, in several assessments of treatment effect such as Disease Activity Score based on 28 joint assessment (DAS28) criteria, American College of Rheumatology (ACR) criteria, physician’s global assessment and erythrocyte sedimentation rate, responses in higher dose groups were greater than in the placebo group. Several patients receiving higher doses of BTT-1023 reached an ACR50 response (i.e. a 50% reduction in their ACR score) during treatment.
"We are very pleased with the good tolerability and pharmacokinetic profile that we saw with BTT-1023 in this study", said Timo Veromaa, President and CEO of Biotie Therapies Corp. "These data, combined with signals of therapeutic activity, provide, in our opinion, a good basis for proceeding into larger therapeutic trials with BTT-1023. We plan to analyze and discuss these data with our partner, Roche, to establish the optimal way to continue the clinical development program. We expect a decision from Roche, regarding its option right to in-license BTT-1023 at this stage of development, during the first half of 2010."
ABOUT STUDY BTT12-CD015
Study BTT12-CD015, conducted within the EU, was a randomized, placebo-controlled, double-blind multiple ascending dose study conducted in 4 sequential cohorts of 6 patients. Within each cohort, 5 patients were randomized to receive active drug and 1 patient to receive placebo under double-blind conditions. The BTT-1023 doses in the sequential cohorts were 1, 2, 4 and 8 mg/kg. In this 4 month study, 5 doses of study drug were administered intravenously at 2 week intervals, with post-treatment follow-up continuing for 9 weeks after the last dose.
The study subjects were required to have active rheumatoid arthritis with a predefined level of breakthrough symptoms while on a stable background regimen of methotrexate. Safety and tolerability were assessed with adverse event inquiries and comprehensive laboratory analyses, while treatment response was assessed with a number of subjective and objective assessments that are widely used in rheumatoid arthritis trials.
A similarly designed companion study in patients with psoriasis (BTT12-CD106) is currently underway, with expected completion by the end of Q2/2010.
ABOUT BTT-1023 AND VAP-1
BTT-1023 is a fully human monoclonal antibody based on Medarex, Inc.’s HuMab technology. The antibody targets Vascular Adhesion Protein 1 (VAP-1), an endothelial adhesion molecule. Inhibiting VAP-1 reduces inflammation by regulating the migration of leukocytes, or white blood cells, to inflamed tissues. Pathological accumulation of white blood cells in tissue is a common feature in many autoimmune diseases, such as rheumatoid arthritis, ulcerative colitis, and psoriasis.
Biotie and Roche have signed an option agreement for the antibody program targeting VAP-1. Under the terms of the agreement, Roche has an exclusive option right to an exclusive, worldwide license agreement for Biotie’s fully human antibody targeting VAP-1, excluding Japan, Taiwan, Singapore, New Zealand, and Australia where rights are licensed to Seikagaku Corporation. The initial option right will end upon completion of Phase I. Roche may extend the option right to later development points by paying additional fees. Biotie will retain all rights to the program until a license is granted to Roche.
ABOUT BIOTIE THERAPIES
Biotie is a drug discovery and development company focused on central nervous system and inflammatory diseases. It has a broad range of innovative small molecule and biological drug candidates at different stages of clinical and pre-clinical development. Biotie’s products address diseases with high unmet medical need and significant market potential, including addiction and psychotic disorders, rheumatoid arthritis, psoriasis and chronic obstructive pulmonary disease (COPD). The most advanced product, nalmefene for alcohol dependence, is currently in phase III clinical development by licensing partner H. Lundbeck A/S.
SOURCE: Biotie
Post Views: 79
Biotie reported that it has successfully completed a clinical trial with its fully human VAP-1 monoclonal antibody (BTT-1023) in rheumatoid arthritis patients
Turku, Finland | January 19, 2010 | Biotie today reported that it has successfully completed a clinical trial with its fully human VAP-1 monoclonal antibody (BTT-1023) in rheumatoid arthritis patients.
The study evaluated the safety, tolerability, and pharmacokinetics of repeated doses of intravenously administered antibody in 24 rheumatoid arthritis patients with an inadequate treatment response to methotrexate. The antibody, administered at repeated doses of up to 8 mg/kg in combination with methotrexate, was generally well tolerated, and no serious or severe adverse events were reported in the study subjects. The pharmacokinetic characteristics of BTT-1023 are consistent with those expected for an intravenously administered monoclonal antibody intended for chronic conditions.
The study was not designed to enable formal statistical evaluation of therapeutic activity. However, in several assessments of treatment effect such as Disease Activity Score based on 28 joint assessment (DAS28) criteria, American College of Rheumatology (ACR) criteria, physician’s global assessment and erythrocyte sedimentation rate, responses in higher dose groups were greater than in the placebo group. Several patients receiving higher doses of BTT-1023 reached an ACR50 response (i.e. a 50% reduction in their ACR score) during treatment.
"We are very pleased with the good tolerability and pharmacokinetic profile that we saw with BTT-1023 in this study", said Timo Veromaa, President and CEO of Biotie Therapies Corp. "These data, combined with signals of therapeutic activity, provide, in our opinion, a good basis for proceeding into larger therapeutic trials with BTT-1023. We plan to analyze and discuss these data with our partner, Roche, to establish the optimal way to continue the clinical development program. We expect a decision from Roche, regarding its option right to in-license BTT-1023 at this stage of development, during the first half of 2010."
ABOUT STUDY BTT12-CD015
Study BTT12-CD015, conducted within the EU, was a randomized, placebo-controlled, double-blind multiple ascending dose study conducted in 4 sequential cohorts of 6 patients. Within each cohort, 5 patients were randomized to receive active drug and 1 patient to receive placebo under double-blind conditions. The BTT-1023 doses in the sequential cohorts were 1, 2, 4 and 8 mg/kg. In this 4 month study, 5 doses of study drug were administered intravenously at 2 week intervals, with post-treatment follow-up continuing for 9 weeks after the last dose.
The study subjects were required to have active rheumatoid arthritis with a predefined level of breakthrough symptoms while on a stable background regimen of methotrexate. Safety and tolerability were assessed with adverse event inquiries and comprehensive laboratory analyses, while treatment response was assessed with a number of subjective and objective assessments that are widely used in rheumatoid arthritis trials.
A similarly designed companion study in patients with psoriasis (BTT12-CD106) is currently underway, with expected completion by the end of Q2/2010.
ABOUT BTT-1023 AND VAP-1
BTT-1023 is a fully human monoclonal antibody based on Medarex, Inc.’s HuMab technology. The antibody targets Vascular Adhesion Protein 1 (VAP-1), an endothelial adhesion molecule. Inhibiting VAP-1 reduces inflammation by regulating the migration of leukocytes, or white blood cells, to inflamed tissues. Pathological accumulation of white blood cells in tissue is a common feature in many autoimmune diseases, such as rheumatoid arthritis, ulcerative colitis, and psoriasis.
Biotie and Roche have signed an option agreement for the antibody program targeting VAP-1. Under the terms of the agreement, Roche has an exclusive option right to an exclusive, worldwide license agreement for Biotie’s fully human antibody targeting VAP-1, excluding Japan, Taiwan, Singapore, New Zealand, and Australia where rights are licensed to Seikagaku Corporation. The initial option right will end upon completion of Phase I. Roche may extend the option right to later development points by paying additional fees. Biotie will retain all rights to the program until a license is granted to Roche.
ABOUT BIOTIE THERAPIES
Biotie is a drug discovery and development company focused on central nervous system and inflammatory diseases. It has a broad range of innovative small molecule and biological drug candidates at different stages of clinical and pre-clinical development. Biotie’s products address diseases with high unmet medical need and significant market potential, including addiction and psychotic disorders, rheumatoid arthritis, psoriasis and chronic obstructive pulmonary disease (COPD). The most advanced product, nalmefene for alcohol dependence, is currently in phase III clinical development by licensing partner H. Lundbeck A/S.
SOURCE: Biotie
Post Views: 79
