Romark begins enrolling patients in Phase 3 trial of NT-300 influenza drug

The trial will enrol 1,400 patients and randomise them with either NT-300, placebo (sugar pill), oseltamivir (Tamiflu) or NT-300 plus oseltamivir.

The primary objectives of the study are to demonstrate if NT-300 reduces the duration of symptoms compared to placebo treatment and NT-300 along with oseltamivir reduces the duration of symptoms compared to NT-300 alone and to oseltamivir alone.

Romark chairman and chief science officer Jean-Francois Rossignol said the trial is designed in such a way that the resulting data support NT-300 marketing application approval for treatment of influenza.

"We are also addressing the opportunity to combine treatment with NT-300 and oseltamivir in an effort to further improve treatment outcomes and mitigate the risk of oseltamivir resistance," Rossignol added.

The study commenced in the US and to be continued in Australia and New Zealand in the southern hemisphere, is expected to be completed during the 2013-2014 flu season in the northern hemisphere.

The Phase 3 trial of NT-300 will be fully funded by the U.S. Department of Health and Human Services (HHS)/Office of the Assistant Secretary of Preparedness and Response (ASPR)/Biomedical Advanced Research and Development Authority (BARDA) under contract HHSO100201300004C.

The value of the cost plus fixed-fee contract is up to $44m.