DGAP-News: AiCuris starts its first pivotal clinical phase 3 trial with pritelivir for the treatment of HSV infections in immunocompromised subjects based on efficacy and safety data from a phase 2 trial
The PRIOH-1 multi-center open label trial is designed to evaluate the efficacy and safety of orally administered pritelivir for the treatment of acyclovir-resistant mucocutaneous HSV infections in immunocompromised patients.
- The PRIOH-1 multi-center open label trial is designed to evaluate the efficacy and safety of orally administered pritelivir for the treatment of acyclovir-resistant mucocutaneous HSV infections in immunocompromised patients.
- Efficacy was also seen in patients who in addition showed resistance or intolerance to foscarnet and had very limited treatment options.
- In none of the patients, treatment with pritelivir was prematurely discontinued due to adverse events during the trial.
- Based on the results from the recent US clinical phase 2 trial, AiCuris has started a pivotal phase 3 trial as a basis for NDA submission.