HDIT101 is a novel therapeutic antibody developed for the treatment of herpes simplex virus (HSV) infections.
In a recently completed first-in-human clinical phase I trial escalating doses up to 12,150 mg HDIT101 were administered intravenously to 18 healthy volunteers at six dose levels to study safety, pharmacokinetics, and immunogenicity of HDIT101. In this trial HDIT101 was well tolerated in all recipients and no serious or severe AEs, no infusion related reactions and no events suggestive of dose limiting off-target toxicity occurred. HDIT101 demonstrated the expected PK properties of a humanized monoclonal antibody, and could be safely administered even at excessively high doses that may be required for treatment of patients with septical HSV spread.
Supported by its excellent safety profile HDIT101 is currently developed in two independent phase II clinical studies: the MATCH-1 trial evaluates studies a topical application of HDIT101 for the treatment of in chronic recurrent HSV-1 induced orolabialal Herpes infection whereas the MATCH-2 study investigates intravenous HDIT-101 in chronic recurrent genital herpes caused by HSV-2.
HSV-1-positive patients with at least 6 orolabial herpes outbreaks per year can be included. Eligible patients will be randomized in a 2:1 ratio to topical HDIT or placebo. The primary endpoint of the trial is the number of recurrences following initial treatment.
This trial has recently completed enrolment and final results are currently analyzed. Patients suffering from chronic, HSV-2 positive genital herpes with at least 4 outbreaks per year were eligible for enrolment. Participants with acute herpes lesions during the screening period were randomized in a 2:1 ratio to a single HDIT-101 or placebo infusion. At subsequent outbreaks patients in the placebo group received episodic Valaciclovir standard-of-care treatment while patients in the HDIT101 group received episodic Valaciclovir placebo capsules.
Primary endpoint was the percentage of days with lesion over 180 day observation period.