相关临床试验
19
6 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
2006
进行中（未招募）
5
26.3%
Available
1
5.3%
已完成
8
42.1%
尚未招募
1
5.3%
招募中
3
15.8%
终止
1
5.3%
暂无批准数据
- Japanese technology group Asahi Kasei announced the acquisition of German biotech Aicuris Anti-infective Cures AG for €780 million in cash, targeting expansion in severe viral infections for immunocompromised patients. - The deal includes three key antiviral compounds: PREVYMIS for cytomegalovirus prevention, Pritelivir which recently achieved its primary endpoint in Phase III trials for herpes simplex virus, and AIC468 for BK virus in kidney transplant patients. - The acquisition leverages Asahi Kasei's existing commercial infrastructure in transplant centers and nephrology, with the transaction expected to contribute positively to operating income from fiscal 2028 onward. - The deal represents a strategic alignment with Asahi Kasei's goal of achieving ¥300 billion in pharmaceutical net sales with 15% operating margin by fiscal 2030.
- AiCuris Anti-infective Cures AG announced that pritelivir met its primary endpoint in the pivotal Phase 3 PRIOH-1 trial, demonstrating statistically significant superiority in lesion healing compared to standard-of-care treatments for immunocompromised patients with acyclovir-refractory HSV infections. - The novel helicase-primase inhibitor showed superior efficacy for treatment up to 28 days (p=0.0047) and even stronger results extending to 42 days (p<0.0001), addressing a critical unmet need in patients with drug-resistant HSV strains. - Pritelivir represents a potential breakthrough as the first new HSV therapy in decades that is active against resistant strains, with AiCuris expecting to file for FDA marketing authorization in 2026.
- Pritelivir demonstrated superior lesion healing rates compared to foscarnet in Phase 2 trial, with 93% vs. 57% of patients achieving healing within 28 days of treatment. - The novel helicase-primase inhibitor showed improved safety profile with zero adverse event-related discontinuations compared to 42.9% for foscarnet in immunocompromised patients. - AIC468, an antisense oligonucleotide targeting BK virus, showed favorable safety and pharmacokinetic profile across all dose cohorts in Phase 1 trial. - Following positive Phase 3 topline results for pritelivir, Aicuris remains on track for NDA submission in 2026 and plans Phase 2 initiation for AIC468 in first half of 2026.
- Pritelivir demonstrated statistically significant superiority (p=0.0047) in lesion healing compared to standard-of-care treatments in immunocompromised patients with refractory herpes simplex virus infections. - The novel helicase-primase inhibitor represents the first HSV treatment innovation in over two decades, offering an oral alternative for patients who fail to respond to current antiviral therapies. - The Phase 3 PRIOH-1 trial enrolled 158 participants across 15 countries, with results expected to support regulatory filings with the FDA and globally in 2026. - Pritelivir's distinct mechanism of action allows it to overcome HSV infections resistant to acyclovir, valacyclovir, famciclovir, and foscarnet, addressing a critical unmet medical need.
