TrialUpdate

AVESTHAGEN Moves Towards Clinicals of its Biosimilar AVENT

AVESTHAGEN announced that it has successfully completed the pre-clinical efficacy trial for one of its biosimilar drugs Avent at Biomedcode Hellas SA. The results indicate that Avent developed by Avesthagen is effective in addressing arthritic conditions.

The global sales of the commercially available reference drug were around $ 6.58 billion in 2009. AVENT is the biosimilar version of a fully humanised soluble tumour necrosis factor (TNF) receptor. AVENT is indicated for reducing signs and symptoms, in patients with moderate to severe rheumatoid arthritis, ankylosing spondylitis, plaque psoriasis, psoriatic arthritis and juvenile idiopathic arthritis.

Pre-clinical efficacy of AVENT was carried out in a USFDA accredited human TNF transgenic murine model for rheumatoid arthritis. In these mice, the human TNFa gene is over-expressed which results in a progressive arthritic phenotype that is similar to that observed in humans. The results show that Avesthagen's biosimilar AVENT was effective in preventing the arthritic pathology developing in the transgenic mice when compared to control mice. Marked improvement was also evident in the group of mice treated with AVENT in comparison to control group of mice, in all scores measured, namely statistically significant arthritis inhibition of ~60 per cent in histopathology and ~80 per cent with in-life clinical measurements.

Avesthagen has successfully developed a proprietary expression vector technology pAVGEN to generate high protein yielding mammalian cell lines. The AVENT cell line have been developed using this proprietary technology. This product is currently being scaled up for clinical trials at Inno Biologics facility in Malaysia. The bioPharmaceutical division at Avesthagen has developed a pipeline of biosimilars using mammalian expression systems, four of which have been granted regulatory approval by the RCGM for initiating pre-clinical toxicity and efficacy studies.

EH News Bureau