Biota Holdings Limited announced today that it has discovered a new class of orally-effective, potent antivirals against RSV (respiratory syncytial virus) infection. Biota has filed worldwide patents and selected a lead candidate with a series of backups for further preclinical development prior to human clinical trials.
RSV infection is an important medical need and already a billion-dollar market, with growing visibility among pharmaceutical companies. The currently marketed drug is an injectable antibody with 2004 sales of approximately US$1 billion ($1.3 billion). However, its use is limited to prevention of infection, not treatment, and it is currently only approved for use in the highest risk group of patients: premature infants. If successful, the Biota RSV drug is expected to have significant advantages and could expand the market to include treatment as well as prevention and to other ‘at risk’ patient segments, such as children, the elderly and people with underlying respiratory conditions.
Latest results in two animal models also demonstrate that Biota’s new RSV antivirals are effective when administered orally. This should allow the product to be developed in a convenient oral formulation, such as a tablet or suspension.
“The discovery of a novel, orally available RSV antiviral is a major achievement,” said Dr Simon Tucker, Vice President of Research for Biota. “Others, including several large pharmaceutical companies, have discovered and disclosed RSV antivirals, but many are inhaled products. Orally effective RSV compounds appear to be a rarity. This is an exciting achievement for Biota and Australian research.”
The current compounds are the result of research conducted by the Biota team over several years. Since 2003, this research has been supported by a $2.7m R&D Start grant from the Australian government. The RSV development follows on the heels of the company’s recent decision to advance its common cold (human rhinovirus, HRV) drug candidate into clinical development following a similarly successful in-house research program.