Theravance CEO Rick Winningham put out the word today that its drug TD-9855 flunked a mid-stage study for attention deficit/hyperactivity disorder, adding that the biotech planned to scrap the program while continuing a separate study for fibromyalgia.
Theravance ($THRX) alerted investors to the failure by way of an SEC filing after making a presentation at the 2013 Credit Suisse Annual Health Care Conference in Scottsdale, Ariz. There were no serious adverse events at either the 5 mg or 20 mg dose of TD-9855, he noted. The most frequent adverse events observed in the study were headache, dizziness, decreased appetite, fatigue and dry mouth.
It's been a topsy-turvy year for Theravance. The company struck a $1 billion-dollar deal with Elan ($ELN) for a slice of the royalty stream GlaxoSmithKline ($GSK) agreed to pay for the COPD drugs Breo and Anoro. Then that deal fell apart after Elan's shareholders spurned the deals struck by then CEO Kelly Martin. Elan was later sold off and Theravance went looking for another deal.
TD-9855 was one of two drugs Theravance has in the clinic for CNS/pain. The drug came out of the company's internal research facilities after preclinical efforts determined that it had potential as a dual norepinephrine and serotonin reuptake inhibitor for ADHD, chronic pain and depression. Phase II work began in late 2011.
- here's the SEC filing