Durect (DRRX)

[INFINITI]

"The topline results from AHFIRM provide compelling evidence that administration of larsucosterol can reduce mortality at 90 days in this devastating disease," said James E. Brown, D.V.M., President and CEO of DURECT. "We have strong rationale to advance larsucosterol into a Phase 3 registration trial designed with adequate power to detect a statistically significant result using 90-day mortality as the primary endpoint. We look forward to meeting with the FDA to discuss next steps. Based on the strength of the clinical data generated to date, if approved, larsucosterol could save many patient lives. We extend our thanks to all the patients, families, clinical trial investigators, and staff across the multiple sites globally who have worked with the DURECT team to bring larsucosterol to this advanced stage."