Aicuris today announced the presentation of new clinical data at ID Week 2025, highlighting progress across two key antiviral programs. Phase 2 results for pritelivir showed a favorable safety profile and higher lesion healing rates compared to foscarnet in immunocompromised patients with HSV infections. These data supported FDA Breakthrough Therapy Designation and the design of the Phase 3 trial, which has recently met its primary endpoint. In addition, first-in-human Phase 1 data for AIC468 demonstrated favorable safety and pharmacokinetics, supporting further development for BK virus infections in kidney transplant recipients.

Aicuris today announced that the Phase 3 trial of its lead candidate pritelivir has met its primary and secondary endpoint. The aim of the trail was to evaluate the safety and efficacy of pritelivir compared to investigator’s choice in treating immunocompromised patients with refractory HSV infection, with or without resistance. Pritelivir demonstrated statistically significant superiority in lesion healing compared with standard-of-care treatments. These results will form the basis for regulatory filings with the FDA and globally.

Aicuris Announces Upcoming Oral and Poster Presentations at ID Week 2025 Aicuris will deliver two oral presentations on the clinical development of pritelivir, and a poster presentation of AIC468. The company’s medical team will also be available for in-person engagement at its booth throughout the conference.

Aicuris presented pharmacokinetics data from its Phase 1 trial of AIC468 at the World Transplant Congress in San Francisco. This novel antisense oligonucleotide is the second clinical candidate in Aicuris’ pipeline and is being developed to treat BK Virus in kidney transplant patients. The new data shows excellent bioavailability, rapid absorption and a favorable half-life and AIC468 was well-tolerated across all cohorts.

Aicuris has enrolled the final participant in their Phase 3 clinical trial of pritelivir. The study aimed to demonstrate superior efficacy and safety of pritelivir vs. investigator’s choice in immunocompromised patients with refractory HSV infections. Pritelivir is the 2nd candidate Aicuris has advanced to this stage, and topline results from the study are expected in Q4 2025.