Biotie Therapies Oyj (FI) - Biotie completes Phase I with VAP-1 antibody - BTT-1023 continues to demonstrate favourable safety profile
Biotie today reported top-line data from a recently completed Phase I study with its fully human VAP-1 monoclonal antibody (BTT-1023) in patients with plaque psoriasis.
The study evaluated the safety, tolerability, and pharmacokinetics of repeated doses of intravenously administered antibody in 26 patients with active plaque psoriasis. The antibody, administered at repeated doses of up to 8 mg/kg, was generally well tolerated, and the pharmacokinetic characteristics of BTT-1023 in psoriasis patients were consistent with those observed in a previously completed study in rheumatoid arthritis (RA) patients. The study was not designed to enable formal statistical evaluation of therapeutic activity. However, whereas no change in disease activity was noted during the treatment period in any patient receiving placebo, several patients on active drug experienced an improvement in their condition, reflected as decreases in their Psoriasis Area Severity Index (PASI) scores and physicians' clinical assessments. No PASI50 responses (50% decrease in PASI score) were observed within the relatively short treatment period. Two patients on active drug were reported to have experienced a transient exacerbation of their psoriasis symptoms that occurred after the treatment had been completed; apart from these two cases, no serious or severe adverse events were reported in the study subjects.
"We are very encouraged by the continued good tolerability and pharmacokinetic profile of BTT-1023", said Timo Veromaa, President and CEO of Biotie Therapies Corp. "The favorable safety data combined with the signals of therapeutic activity that we saw particularly in our rheumatoid arthritis study form, in our opinion, a solid Phase I package for BTT-1023. In addition, our recent non-clinical activities have uncovered interesting therapeutic potential for BTT-1023 beyond RA; this provides us with several attractive opportunities for BTT-1023 in inflammatory conditions, including respiratory disease. We will evaluate these data in detail to determine the best way forward and, at the same time, will continue our ongoing discussions with potential license partners."
Turku, 14 September 2010
Biotie Therapies Corp.
Timo Veromaa President and CEO
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ABOUT STUDY BTT12-CD016
Study BTT12-CD016, conducted within the EU, was a randomized, placebo-controlled, double-blind multiple ascending dose study. After an open-label single-dose pilot phase involving 2 patients, the double-blind part of the study was 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 3 month study, 3 doses of study drug were administered intravenously on study days 1, 8 and 22, with post-treatment follow-up continuing for 9 weeks after the last dose.
The study subjects were required to have active plaque psoriasis, with their Psoriasis Area Severity Index (PASI) scores and affected body surface areas (BSA%) within predefined ranges. 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 psoriasis trials.
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 has licensed the rights to develop and commercialize BTT-1023 in Japan, Taiwan, Singapore, New Zealand and Australia to Seikagaku Corporation. Biotie retains ownership in the rest of the world and is looking for additional collaboration opportunities.
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.
The commercial value of the pipeline has been demonstrated through existing alliances with top-tier global pharmaceutical companies such as Lundbeck, Roche and Pfizer. Biotie has operations in Turku, Finland and Radebeul, Germany.
Biotie shares are listed on NASDAQ OMX Helsinki Ltd.
For more information, please refer to www.biotie.com
Posted: September 2010