GroPep's phase 1 PV903 trial meets primary objective

By Elaine Rigoli

Tampa, Fla., Sept. 14 - GroPep Ltd. has completed its phase 1a trial of infertility drug PV903 and said the trial met its primary objective in demonstrating that vaginally administered PV903 gel is safe and well-tolerated.

The trial did not meet one of its secondary objectives, as there was no change in vaginal immune cell populations or cytokine levels when comparing treatment to a placebo gel alone.

The Adelaide, Australia, pharmaceutical company said the other secondary objective was achieved, showing that systemic PV903 was not detected following a single intravaginal administration of PV903 gel.

Thirty-six healthy female volunteers ages 18 to 41 each received a single administration of PV903 gel or a placebo. Subjects were enrolled sequentially into three groups of 12, with the dose of PV903 gel escalating between groups.

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