Simplexia initiates preparatory clinical study ahead of planned Phase 1/2a HSV-2 vaccine trial

Gothenburg, Sweden 260707

Simplexia AB today announced the initiation of SIMCT-001, an exploratory clinical study designed to support the planning and execution of the company’s forthcoming Phase 1/2a clinical trial of its genital herpes (HSV-2) vaccine candidate.

The SIMCT-001 study is primarily intended to establish key study procedures and ensure operational readiness ahead of the next stage of clinical development. In addition, the study will generate exploratory data on immune responses in individuals living with genital herpes.

Genital herpes, primarily caused by herpes simplex virus type 2 (HSV-2), is a chronic infection with highly variable clinical expression. While some individuals experience frequent and symptomatic recurrences, others remain largely asymptomatic. Understanding these differences remains a challenge and highlights the need for validated clinical approaches.

This non-interventional study will include approximately 20 individuals with different levels of genital herpes disease severity. The study will involve collection and analysis of biological samples as well as information on participants’ symptoms, recurrence frequency and treatment history.

“This study is an important step in preparing for our planned Phase 1/2a clinical trial,” says Nina Lindblom, CEO of Simplexia AB. “Its primary purpose is to establish key study procedures and operational readiness while generating exploratory data on immune responses in individuals living with genital herpes.”

The study will be conducted at Studieenheten Akademiskt Specialistcentrum, Sabbatsberg Hospital in Stockholm, Sweden.

Despite decades of research, no vaccine against HSV-2 has yet demonstrated sufficient clinical efficacy. Advancing new scientific insights into clinical evaluation remains essential to addressing this significant unmet medical need.

This study is an important step in preparing for our planned Phase 1/2a clinical trial

Nina Lindblom

CEO and Head of clinical development