Durect’s stock nose-dived more than 30% yesterday on the news that its phase 2 plaque psoriasis hope failed to beat out a sham treatment.
The drug, known as DUR-928 and used here as a topical treatment, was pitted against placebo for around a month in just under two dozen patients.
The results: “DUR-928 did not demonstrate a benefit over vehicle (placebo) based on Investigator's Global Assessment (IGA), which was the scoring system for the primary analysis, or in any of the secondary analyses,” i.e., it failed.
The company will now cease working on the epigenetic regulator in psoriasis, it said in a statement.
The future of the drug now rests in treating liver disease, both fatty liver and alcoholic hepatitis, where it has had better results.
Just last month at the annual Liver Meeting in Boston, the California-based company presented data showing all 19 patients who received DUR-928 were still alive 28 days after treatment and that it reduced their Maddrey discriminant function and Model for End-Stage Liver Disease (MELD)—scores that reflect the likelihood someone with alcoholic hepatitis will die within a certain period of time.
It also reduced levels of serum bilirubin, a marker of liver disease.
Durect is now working with investigators to design a phase 2b study in alcoholic hepatitis that will include “a significantly higher number of patients,” the company told FierceBiotech recently.
If that study yields similar results, it will be able to go full steam ahead into phase 3 and, they hope, regulatory approval.
The biotech is also planning on completing its phase 1 nonalcoholic steatohepatitis trial in the first half of this year, although there is much competition and a whole load of rocky roads in development terms there.
The flop in psoriasis still dented confidence in the company, with shares down 31% yesterday on the news, although this ticked up slightly after-hours.
The biotech also has partnerships with Novartis and Gilead Sciences, with the former focused on a painkiller med (which has also seen setbacks and failures) and the latter penned last year and centering on a long-acting HIV therapy.