Biotie completes Phase I with VAP-1 antibody - BTT-1023 continues to demonstrate favourable safety profile

15-Sep-2010 - Finland

Biotie 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."

https://www.bionity.com/en/news/122830/biotie-completes-phase-i-with-vap-1-antibody-btt-1023-continues-to-demonstrate-favourable-safety-profile.html