Larsucosterol rebounds to snag FDA breakthrough status for alcohol-related hepatitis
Click Here to Manage Email Alerts
The FDA has granted breakthrough therapy designation to Durect’s larsucosterol for the treatment of patients with severe alcohol-associated hepatitis, despite mixed results from previously released topline data.
“We’re pleased with the FDA’s decision to grant breakthrough therapy designation to larsucosterol, as it further recognizes its potential to save the lives of [alcohol-associated hepatitis] patients,” James E. Brown, DVM, president and CEO of Durect, said in a company press release. “[Alcohol-associated hepatitis] has a high mortality rate and no currently approved treatments, so there is a great need for a safe and effective therapy.”
In November 2023, Durect released topline results from its phase 2b AHFIRM trial, which reported that both 30 mg and 90 mg doses of larsucosterol demonstrated “a compelling and clinically meaningful trend in reduction of mortality at 90 days” for patients with alcohol-associated hepatitis compared with standard of care. However, both larsucosterol doses failed to meet the trial’s primary endpoint of “numerical improvement” of mortality or liver transplant at 90 days.
“We continue to finalize the design of our planned registrational phase 3 trial for larsucosterol, incorporating the recent FDA feedback and promising data from our completed phase 2b AHFIRM trial,” Brown said. “We look forward to releasing additional clinical data on larsucosterol and potentially bringing this therapy to patients as soon as possible.”
The company noted that additional trial data will be presented at a late-breaking oral presentation on June 8, 2024 during the EASL Congress in Milan, Italy.
The FDA grants breakthrough designation to expedite development of drugs or devices intended to treat serious conditions and supported by clinical evidence indicating that the product may demonstrate substantial improvement over currently available drugs or devices. Breakthrough designation is intended to accelerate drug/device development, assessment and review for premarket approval, 510(k) clearance and de novo marketing authorization, while still meeting FDA standards for safety and effectiveness.
Reference:
- Durect corporation announces topline results from phase 2b AHFIRM trial of larsucosterol in alcohol-associated hepatitis with promising effect on mortality. https://www.durect.com/2023/11/durect-corporation-announces-topline-results-from-phase-2b-ahfirm-trial-of-larsucosterol-in-alcohol-associated-hepatitis-with-promising-effect-on-mortality/. Published Nov. 7, 2023. Accessed May 21, 2024.
Read more about
Click Here to Manage Email Alerts