Double-blind placebo-controlled clinical trial (Phase 1b/2a) to evaluate safety and efficacy of weekly administration of IM-250 in patients with recurrent genital herpes

Genital herpes infection

• Rate of HSV shedding, defined as number of days on which genital swab HSV PCR test was positive divided by the total number of days on which genital swabs were obtained in patients receiving different doses of IM-250 or placebo.

• Rate of genital lesions, defined as number of days with genital lesions in all patients of a group during 28 days after the first administration of IM-250 or placebo divided by 28., • Rate of genital lesions, defined as number of days with genital lesions in all patients of a group during 56 days after the first administration of IM-250 or placebo divided by 56., • HSV quantity, defined as comparison of mean log10 HSV DNA copies in patients receiving different doses of IM-250 or placebo on days that shedding is detected., • The rate of subclinical shedding, defined as number of days on which genital swab HSV PCR test was positive in absence of a genital lesion divided by the total number of days without lesions on which genital swabs were obtained in patients receiving different doses of IM-250 or placebo., Determining the exposure by different doses of IM-250 as defined by: • the area under the curve from 0 to infinity (AUC0-ꚙ), • maximum concentration (Cmax), • plasma concentration at 24 hours (C24h) and 8 d (C8d), • the area under the curve from 0 to 24 hours (AUC0-24), • time to reach Cmax (Tmax), • half-life (t1/2), • apparent clearance (Cl / F), • mean residence time (MRT), • volume of distribution (Vd), • the time above the specified lower target concentration (T>Ctarget).

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