Study of Topical ABI-1968 in Subjects With Precancerous Anal Lesions Resulting From Human Papillomavirus (HPV) Infection

Inclusion Criteria

1. Female or male subjects, at least 27 years old.

2. Confirmed diagnosis of intra-anal HSIL at least 3 months prior to screening and
confirmed by histopathology (with p16 positive staining)

3. Intra-anal HSIL are visible and evaluable by HRA at the time of screening, and no
lesion(s) is suspicious for invasive cancer.

4. For HIV-positive subjects, CD4 count must be at least 200/mm3 with undetectable (<50
copies/mL) viral load within the 3 months prior to enrollment. Subjects must be on a
stable regimen of antiretroviral drugs for the 3 months prior to enrollment.

Exclusion Criteria:

1. Women who are pregnant, plan to become pregnant in the next 3 months, or lactating
females.

2. Received topical treatment or ablative procedures for aHSIL in the 6 months prior to
enrolment.

3. History of cancer involving the anogenital region, or history of other cancers that
have not been fully resolved and free of symptoms in the past 5 years

4. History of genital herpes with > 3 outbreaks per year.

5. Plan to have excision or ablation of the lesion(s) within 3 months of enrolment.