Durect shares stumble as top drug fails mid-stage trial
Durect’s shares are crashing again.
Two years after a Novartis-partnered Phase III flop sent them into penny stock territory, Durect has failed another trial for a top candidate. This time, though, the biotech may have better fallback options.
DUR-928, the lead drug in Durect’s epigenetic regulator program, was tested in 28 plaque psoriasis patients. Each patient served as their own control, with the drug administered to one arm and the placebo administered to the other. The good news was that there was no meaningful difference in adverse effects between the two arms. The bad news was there didn’t seem to be much of a difference at all, as DUR-928 “did not demonstrate a benefit over vehicle (placebo)” and missed all primary and secondary endpoints.
Durect’s shares $DRRX, which had been rising for months, fell 34% to $2.50.
Durect announced it is discontinuing the topical psoriasis program, but that is only one of the three indications in which the biotech is testing DUR-928. They also have an injectable form of the drug in Phase II for alcoholic hepatitis and an oral form in Phase I for nonalcoholic steatohepatitis, better known as NASH. Positive results came out for the alcoholic hepatitis program in November; patients in the treatment arm saw a statistically significant reduction in bilirubin, the yellow substance in bile that gives patients the well-known jaundiced look.
The trial failure comes as the biotech prepares for a key regulatory date for the Novartis-partnered drug, a post-operation non-opioid pain drug now called Posimir. The drug has had a rocky history, including a 2012 trial failure, a 2014 CRL from the FDA, and a 2016 request from the agency to change their trial design, helping lead to the 2017 failure.
Durect responded to the CRL this past June, repackaging their original submission to focus on six trials. It’s not yet clear what the FDA will say, but the new submission convinced the agency to delay an early PDUFA date of December 27 and give the biotech an adcomm meeting for later this month.
The Durect program with the most potential, though, may end up being their long-acting injectable HIV candidate, part of their SABER platform. Gilead paid $25 million upfront and promised millions more in milestones to latch onto that platform. They optioned the HIV drug in September for a $10 million payment.