Trevena, Inc. (TRVN) announced on Monday plans to upsize the phase IIb BLAST-AHF trial, testing TRV027 in acute heart failure (AHF), and to focus on the middle dose being tested in the study. The trial will be expanded from 500 to 620 patients and will weight enrolled patients towards what Trevena characterizes as the most promising dose, 5mg/hr, plus standard heart failure therapy versus placebo plus standard of care.
Actavis (ACT) holds an exclusive option to license TRV027 and is funding the $10 million expansion. Actavis can exercise its option for worldwide rights to the drug after the phase IIb is complete, for a $65 million fee and $365 million in potential milestones. Trevena would also receive royalties on global sales of the product. Actavis acquired the TRV027 rights after purchasing Forest Labs, which put up $30 million for an equity stake in TRVN in 2013.
The decision to move towards a weighted study favoring a 5mg/hr dose comes after the completion of a planned interim analysis of 254 patients. As a result, remaining enrollment will now be weighted 2:1:2:1 for placebo, 1 mg/hr, 5 mg/hr, and 25 mg/hr, respectively, favoring the middle dose. One might reasonably deduce that the decision to maintain the significantly higher 25 mg/hr dose despite that 5mg/hr is, apparently, an ideal dose, suggests that no noteworthy side effects have been observed at this high dose.
Trevena expects to report data from this trial in the first half of 2016.
Trevena, Inc. went public in early 2014 and is a clinical stage company currently pursuing four drug candidates: TRV027 to treat acute heart failure, TRV130 intravenously treat moderate to severe pain, TRV734 to orally treat moderate to severe pain, and TRV250 to treat migraines.
