Wuppertal, Germany — October 16, 2025 — Leads & Copy — Aicuris Anti-infective Cures AG announced its registrational Phase 3 trial (PRIOH-1, NCT03073967) for pritelivir, a helicase primase inhibitor for HSV, met its primary endpoint with statistical superiority (p=0.0047) in lesion healing in patients treated for up to 28 days.
Statistical superiority in lesion healing increased in patients receiving up to 42 days of treatment (p<0.0001). The trial evaluated pritelivir’s efficacy and safety versus standard-of-care (SoC) in immunocompromised patients with refractory HSV infection.
Genovefa Papanicolaou, MD, from Memorial Sloan Kettering Cancer Center, noted the Phase 3 trial as a significant advancement, citing the lack of HSV treatment innovation for this patient group and pritelivir’s potential to improve quality of life, particularly for resistant patients.
Pritelivir, an oral therapy, targets the helicase-primase complex of HSV, overcoming infections resistant to treatments like acyclovir, valacyclovir, famciclovir, and foscarnet. Its superior efficacy and favorable safety profile address unmet needs of immunocompromised patients.
Aicuris CEO Larry Edwards stated the company’s goal of demonstrating pritelivir’s statistically superior treatment benefit has been achieved and plans to rapidly advance their New Drug Application submission to the FDA. CMO of Aicuris, Cynthia Wat, MD, believes Pritelivir could be a paradigm shift for immunocompromised patients.
The trial involved 158 immunocompromised participants across 15 countries. Pritelivir-treated patients received a loading dose of 400 mg on the first day, followed by 100 mg daily until lesions healed. 102 resistant patients were randomized 1:1 and treated with pritelivir or investigator’s choice to demonstrate superior efficacy and evaluate safety. Additional patients were treated with pritelivir in two non-randomized cohorts.
Pritelivir has FDA breakthrough designation and the outcomes of this pivotal Phase 3 trial are expected to serve as a basis for filing for marketing authorization in 2026.
Contact:
Aicuris Anti-infective Cures AG
info@aicuris.com
Trophic Communications
Dr. Stephanie May and Anja Heuer
Phone: +49 171 1855682
Email: aicuris@trophic.eu
Source: Aicuris Anti-infective Cures AG
