Aicuris Announces Pritelivir Phase 3 HSV Data to Be Presented as Late-Breaking Oral Presentation at Tandem

GlobeNewswire | AiCuris Anti-infective Cures AG
Today at 10:05am UTC

Wuppertal, Germany, January 29, 2026 - Aicuris Anti-infective Cures AG (“Aicuris”) today announced that the company will be presenting the results of pritelivir from their pivotal Phase 3 trial (PRIOH-1, NCT03073967) as a late-breaking oral presentation at the upcoming Tandem Meetings 2026 on February 7 in Salt Lake City, USA. Pritelivir, a novel helicase-primase inhibitor, met its primary endpoint of complete lesion healing in immunocompromised patients infected with refractory herpes simplex virus (HSV) in October 2025.

Full abstracts will be released on February 4, 2026, at 7:00 am CET/1:00 am EST and will be available via the conference website here.  

Details of the Late-Breaking Oral Presentation:

Abstract Title: Pritelivir demonstrated superior efficacy compared to investigator’s choice treatment for refractory herpes simplex virus infections in immunocompromised patients: PRIOH-1, phase 3 safety and efficacy
Presenting author: Genovefa Papanicolaou, MD, Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College, Cornell University, New York, USA
Date: Saturday, February 7, 2026
Time: 3:55 PM MST / 11:55 PM CET / 5:55 PM EST

About Pritelivir
Pritelivir, a novel helicase-primase inhibitor developed by Aicuris, targets both HSV-1 and HSV-2. These viruses are responsible for genital, oral, or disseminated infections with increasing severity and limited treatment options, particularly in immunocompromised patients where resistance to existing antivirals is a significant clinical challenge. Unlike traditional antivirals, pritelivir blocks viral DNA synthesis by inhibiting the helicase-primase complex, a mechanism distinct from marketed nucleoside analogues. Because of this distinct mode of action, pritelivir is active against strains resistant to nucleoside analog-based therapies.1 Earlier clinical trials in immunocompetent and immunocompromised individuals showed a favorable safety profile and early signals of clinical efficacy compared to standard of care treatments like valacyclovir and foscarnet. Based on these results, pritelivir was granted FDA Breakthrough Therapy designation. In October 2025, Aicuris announced that pritelivir met its primary endpoint in the pivotal Phase 3 trial. The company expects to file for marketing authorization with the U.S. FDA in 2026.

About Aicuris
Aicuris is meeting the needs of the growing population of immunocompromised people who require precise therapies to effectively treat infection. Our flagship product, PREVYMIS®, marketed by our partner MSD, prevents CMV in a defined group of transplant recipients. Our pivotal Phase 3 candidate, pritelivir, aims to address refractory HSV infections in a broad population of patients with weakened immune systems. For immunocompromised people, an otherwise manageable infection can mean life or death. Aicuris, with its expertise and growing pipeline, is committed to providing therapeutic solutions for them now and in the future.

Contact:
Aicuris Anti-infective Cures AG
info@aicuris.com

Trophic Communications
Dr. Stephanie May and Anja Heuer
Phone: +49 171 1855 682
Email: aicuris@trophic.eu


1 Sallée, L. and Boutolleau, D. (2024), Management of Refractory/Resistant Herpes Simplex Virus Infections in Haematopoietic Stem Cell Transplantation Recipients: A Literature Review. Rev Med Virol, 34: e2574. https://doi.org/10.1002/rmv.2574

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