Tokyo-based global pharmaceutical company Daiichi Sankyo Limited announced today, Monday, that their new anti flu drug CS-8958 (generic name laninamivir) has shown “positive top line results” in a phase III trial that compared its safety and effectiveness with Tamiflu.
The company, which co-owns the drug with Australia’s Biota Holdings Ltd, hopes to file for government approval within the current financial year which ends in March 2010, and said that non-clinical studies suggest the drug is not only effective against seasonal flu but also works against the new H1N1 swine flu virus and the avian H5N1 flu virus.
The phase III trial which is known as MARVEL, or the Multinational Asian Clinical Research for Influenza Virus Extermination on Long-Acting Neuraminidase-Inhibitor study, was a double-blind and active controlled study that compared the safety and efficacy of laninamivir against the market leader, oseltamivir (Tamiflu). The participants were patients living in Japan, Taiwan, Hong Kong and Korea.
According to Daiichi Sankyo, the topline results showed that both the 20 mg and the 40 mg single inhalation dose of laninamivir performed as well as a 75 mg twice daily oral dose of Tamiflu for 5 days (ie total of 10 doses of Tamiflu) in adults infected with influenza A or B virus. The primary measure was the time it took to alleviate the illness and the 40 mg dose was more effective than the 20 mg dose at doing this.
Both doses were well tolerated, said the company announcement.
The company also said that in a separate similarly designed parallel trial in children, the new drug performed even better than Tamflu at both the 20 mg and the 40 mg dose, which were both “well tolerated in pediatric patients”.
As well as filing for government approval in this fiscal year, the company will be starting another clinical study to test the drug as a prophylaxis or preventive drug.
CS-8958 (laninamivir) is a neuraminidase inhibitor that is retained for a long time in the target organ after it is inhaled.
The company said that non-clinical studies suggest the drug may not only work against seasonal flu, but also against the novel H1N1 swine flu, and against the avian H5N1 virus.
Peter Cook, Biota’s Managing Director, told the press that:
“The success of the multifaceted Phase III trials in Asia is significant. Laninamivir offers a new therapeutic agent in the treatment of influenza with particular advantages for stockpiling applications.”
Biota are the developers of zanamivir, another neuraminidase inhibitor designed to treat and prevent influenza and which is currently marketed by GlaxoSmithKline as Relenza.
In the meantime, another Japanese company, Shionogi & Co, are developing a similar type of anti flu drug, but an article in the Wall Street Journal today suggests that Daiichi Sankyo’s apparent success with the pediatric studies could put it ahead of the game because the Japanese government has said that children under 10 are the most vulnerable group to influenza.
Sources Daiichi Sankyo, Biota Holdings, Wall Street Journal.
Written by: Catharine Paddock, PhD