Advancis drug flunks trial

Shares of Advancis Pharmaceutical were sinking this morning after the drug developer announced its Amoxicillin PULSYS Phase III clinical trial for pharyngitis/tonsillitis due to strep throat failed to hit its primary endpoint. The trial compared Advancis' Amoxicillin PULSYS 775 mg tablet dosed once-daily for seven days to 250 mg of penicillin VK dosed four times daily for 10 days. According to top-line trial data, Amoxicillin PULSYS failed to demonstrate statistical non-inferiority to the comparator therapy in the primary endpoint: bacterial eradication at the post-therapy test-of-cure visit for patients who successfully completed the trial protocol. Advancis has been developing the therapy with Par.

- read this press release for more

Suggested Articles

Novo Nordisk and Dicerna are teaming up on liver-related diseases, including nonalcoholic steatohepatitis (NASH), to the tune of $225 million.

After announcing it was slashing scores of jobs, Alkermes is now willing to put down nearly $1 billion to buy out CNS biotech Rodin Therapeutics.

The top-line readout appears to justify the risk the partners took when they advanced the drug despite missing the primary endpoint in phase 2.