相关临床试验
5
5 进行中
药物批准
0
批准总数
监管机构
0
监管机构数
成立时间
N/A
进行中（未招募）
5
100.0%
暂无批准数据
- Bausch Health announced the acquisition of DURECT Corporation for $63 million upfront, with potential milestone payments up to $350 million, to gain access to larsucosterol, an epigenetic modulator with FDA Breakthrough Therapy Designation for alcoholic hepatitis. - Larsucosterol represents a potential first-in-class treatment for alcoholic hepatitis, a life-threatening condition responsible for approximately 100 deaths per day in the US and 164,000 hospital admissions in 2021, with no currently approved therapies. - The acquisition strengthens Bausch Health's hepatology portfolio alongside their ongoing Phase 3 rifaximin SSD program, with a registrational Phase 3 trial for larsucosterol planned to evaluate 90-day survival in severe alcoholic hepatitis patients.
- Phase 2b AHFIRM trial results published in NEJM Evidence demonstrate larsucosterol reduced 90-day mortality by up to 41% in alcohol-associated hepatitis patients compared to placebo. - U.S. patient subgroup analysis revealed even more substantial mortality reductions of 57-58% with both 30mg and 90mg doses, showing strong statistical significance. - The drug demonstrated a favorable safety profile with treatment-emergent adverse events comparable to placebo, marking a potential breakthrough for a condition with no FDA-approved therapies.
- DURECT Corporation's larsucosterol demonstrates potential in treating alcohol-associated hepatitis (AH) by reducing mortality rates in U.S. patients. - A Phase 3 trial, agreed upon with the FDA, will assess larsucosterol's efficacy with a 90-day survival primary endpoint, aiming for topline data within two years. - Larsucosterol targets DNA methyltransferases, epigenetic enzymes linked to hypermethylation in AH, offering a novel approach to managing the condition. - Data from the AHFIRM Phase 2b trial supports the Phase 3 design, showing significant mortality reduction with larsucosterol in U.S. patients.
