Safety and efficacy of monoclonal antibody therapy in patients with chronic herpes simplex virus-2 genital infections: MATCH-2, a randomized double-blinded, parallel-group phase 2 multi-center trial

作者：Hans‐Jürgen Stellbrink, Torsten Schaller, K. Sturm, Norbert H. Brockmeyer, Anja Potthoff, Markus Bickel, Stefan Scholten, Nils Postel, Arne Jessen, Matthias C. Müller, Dirk Jäger, Christian Müller, Narges Seyfizadeh, Stefan Hans Schöffel, Bernd Ullrich, Laura Brosi, Claudia Kunz, Daniel Thomas, Rico Laage, Frank Hanakam, Matthias Schwab, Oliver Schönborn‐Kellenberger, Marina Mangold, Katharina Och, Thorsten Lehr, Michaela Anja Elisabeth Arndt, Jürgen Krauß · 发表于：Pharmacological Research · 年份：2025 · DOI：10.1016/j.phrs.2025.107999 · 被引用次数：2 · 研究领域：Herpesvirus Infections and Treatments、Systemic Lupus Erythematosus Research、Urticaria and Related Conditions

Frequent anogenital recurrences in Herpes-Simplex-Virus type 2 (HSV-2) infected individuals remain a global health challenge. Nucleoside analogues, with limited clinical efficacy, have been the standard treatment for decades. The humanized antibody HDIT101 is a first-in-class biologic under clinical development for HSV-related diseases. In this randomized, double-blinded, phase 2 multi-center parallel-group trial, HSV-2 seropositive patients with ≥ 4 annual anogential recurrences were enrolled. Following an initial pre-treatment observation phase in which anogenital swabs were taken for a maximum of 28 days patients were randomly assigned (2:1) at the occurrence of an outbreak to either receive a single 2 g intravenous dose of HDIT101 or infusional HDIT101 buffer placebo solution. At each recurrence during the 180-day trial period patients in the HDIT101 arm received episodic oral valacyclovir placebo (twice daily for 3 days) or valacyclovir (500 mg twice daily for 3 days) in the control arm. Post-treatment viral shedding was monitored by daily anogenital swabbing for 28 consecutive days starting immediately after infusional treatment and at day 150. Ordered statistical testing was applied to control for multiplicity. From 122 patients (full-analysis-set, FAS), 36/41 in the VAL arm and 67/81 in the HDIT101 arm completed the trial per-protocol (per-protocol-set, PPS). Adverse events were mild/moderate and similar between treatment arms. The primary endpoint, percentage of days...