Phase II Study of Dysplasix™ Intravaginal Suppositories in Patients Patients With High-Risk HPV and Mild Cervical Cytologic Abnormalities

AMP.2025.001 is a Phase II, Double-Blind, randomized, Placebo-Controlled, Proof-of-Concept study to assess the safety and efficacy of Dysplasix™ Intravaginal Suppositories in females with hr-HPV and one of the following: cytologically confirmed (1) Atypical Squamous Cells of Undetermined Significance (ASC-US) or (2) Low-Grade Squamous Intraepithelial Lesions (LSIL)

Participants must undergo both (1) HPV testing and (2) a liquid-based exfoliative cytology test.

If, at laboratory screening, high-risk HPV and either (1) ASC-US or (2) LSIL cytologic abnormalities are detected, participants will be eligible for inclusion. If high-grade SIL (HSIL) or glandular abnormalities (AGC-NOS, AGC-N, AIS) are detected, participants will be excluded.

Eligible participants with high-risk HPV and either (1) ASC-US or (2) LSIL cytology will be randomized in a 1:1 ratio to Dysplasix™ or a matching Placebo until participants who meet eligibility are enrolled. Suppositories (Dysplasix™) or placebo will be intravaginally self-administered once nightly for a fifteen (15) day course of therapy (3 cycles of 5 days followed by two days off between cycles) applied at night immediately before sleep, beginning shortly after the end of menses. Tolerability of the drug will be recorded in daily participant diaries and assessed at regularly scheduled clinical assessment visits.

Participants will undergo complete cervical screening, including hr-HPV testing and cytology 30 (+/- 14) days after completion of treatment in addition to adverse events assessments.

Adverse events are evaluated using Common Terminology Criteria for Adverse Events v5.0.

Inclusion criteria

Participants must meet all the following criteria to be eligible to enroll in the study:

• Participants capable of giving informed consent
• Females, ages 18 to 65 years old at the time of signature of the informed consent form.
• Participants who are able to correctly self-administer the intravaginal suppositories
• One or more hr-HPV oncotypes as confirmed by HPV test
• Participants with ASCUS or LSIL abnormalities as confirmed by cytology
• Immune competent
• Participants of childbearing potential must have a negative pregnancy test at screening.
• Participants of childbearing potential must agree to use appropriate contraception or abstain from sexual intercourse for the duration of the study
• Participants must not have received a recent HPV vaccination and must abstain from HPV vaccination until the end of study

Exclusion criteria

Participants meeting any of the following criteria will be excluded from the study:

• Presence of HSIL at screening cytology
• Evidence of glandular abnormalities (AGC/AIS) at screening cytology
• BMI below 16
• Pregnant or nursing females
• Evidence of vaginal/vulval comorbidities, specifically, common sexually transmitted or vaginal infections, and bloodborne pathogens
• Using a vaginal contraceptive ring
• History of irregular menstrual cycles or routine intermenstrual bleeding
• Active autoimmune disease
• Taking prohibited concomitant medications
• Concurrent malignancy except for non-melanoma skin lesions
• Active participation in another clinical trial involving therapeutic intervention (unless ending within 30 days of screening date)