AVONTEC's lead product AVT-01 advances into multiple-dosing Phase 2a studies in asthma

Novel decoy technology makes transcription factor target drugable

15-Nov-2006

AVONTEC´s asthma drug candidate AVT-01 has entered a multiple dosing phase 2a clinical study in the United Kingdom and Romania. Last week, the English regulatory body, the Medicines and Healthcare products Regulatory Agency, and the Romanian regulatory body, the Romanian National Medicines Agency, approved the start of the study on AVT-01 in patients with asthma.

According to the company, this approval is based on AVONTEC´s clinical trial application, which contains a broad and comprehensive data base on information provided by the company on the CMC, toxicology, safety pharmacology and genotoxicity of the drug candidate. AVT-01 is a short, double-stranded oligodeoxynucleotide (ODN) "decoy" that effectively inhibits the transcription factor STAT-1. This transcription factor represents a novel drug target which acts at the level of innate immunity and has been shown to be strongly involved in chronic inflammation. AVT-01 is believed to be the first ODN-based drug candidate to enter clinical trials that attenuates the activity of a transcription factor in a specific and selective way.

AVONTEC has already demonstrated that AVT-01 reduces inflammation in numerous pharmacological animal models. Single doses of AVT-01 also attenuated bronchial hyperresponsiveness in humans, as demonstrated in a single dose phase 2a study, which was presented at the American Thoracic Society convention in May, 2006.

Concurrent with this Phase 2a trial, AVONTEC is embarking upon a series of multiple dosing phase 2a studies in order to further demonstrate the safety and efficacy of AVT-01 in asthma. Results from these studies are expected for Q4/2007.

https://www.bionity.com/en/news/59468/avontec-s-lead-product-avt-01-advances-into-multiple-dosing-phase-2a-studies-in-asthma.html