Data Readout

Amplexd sets Q1 2027 readout for EGCg suppository in HPV cervical lesions

The randomized, placebo-controlled Phase 2 trial will test whether a self-administered topical can clear high-risk HPV and reverse mild cytologic abnormalities now managed by watchful waiting.

By AppliedXLJuly 13, 2026Trial NCT07572396

Executive Summary

A Phase 2 study is testing whether a self-administered topical therapy can clear high-risk HPV and reverse mild cervical abnormalities that are today mostly just monitored rather than treated.
The study is recruiting on schedule, with its enrollment target unchanged and only a routine eligibility update on record, so the readout timeline itself carries little operational risk.
The therapy sits without a direct comparator that shares both its molecular target and its drug class in this disease setting, and the broader mechanism has seen its field activity fall to zero recent trials from a larger prior base.
A result showing hr-HPV clearance and cytology regression with a tolerable safety profile would offer the first Phase 2 evidence for a non-surgical, self-administered option in a stage of disease that current practice treats mainly with surveillance.

The trial

Amplexd Therapeutics, Inc. is conducting a randomized, placebo-controlled Phase 2 study (NCT07572396) of an epigallocatechin gallate (EGCg)-based intravaginal suppository, branded Dysplasix, in women with confirmed high-risk HPV genotypes and mild cervical cytologic abnormalities, specifically ASCUS or LSIL findings. The trial is enrolling 45 patients at sites affiliated with The Chinese University of Hong Kong and Prince of Wales Hospital. Its three primary endpoints are clearance of the hr-HPV genotype present at study entry, regression of cervical cytology present at study entry, and safety and tolerability of the suppository. The primary completion date on file is December 27, 2026, and the company has said clinical data are expected in the first quarter of 2027. NCT07572396+1

Probability of Success

Endpoint Met25%

Completes95%

Clinical Significance3%

Regulatory44%

The unmet need

Amplexd's chief executive, Alia Rahman, said roughly 5% of cervical screenings in the US reveal abnormalities, the majority of them low-grade, and that these cases are typically managed through increased surveillance, or watchful waiting, rather than active treatment, while advanced disease often requires surgical intervention that is not uniformly accessible. The company frames its formulation, a shelf-stable suppository intended for self-administration at the site of disease, as an attempt to intervene earlier in that gap between watchful waiting and surgery. The trial is testing that premise directly: whether topical, patient-administered dosing can produce measurable viral clearance and lesion regression in a population that today receives no active drug therapy. Amplexd

Protocol standing

The study has one recorded registry event since it was added on May 7, 2026, an eligibility-criteria adjustment, and shows no change to its enrollment target, no primary-completion-date amendment, and no post-completion endpoint change. Enrollment stands at 45 patients against an anticipated target of the same size, a hold rather than a cut. The registry-churn proxy for this study reads Stable with zero change events per year. None of this bears on the scientific outcome; it means the readout is more likely to arrive on the timeline the company has given rather than slip for administrative reasons. NCT07572396

The competitive field

No industry trial combines the CXCL2 target with a small-molecule modality in this indication, so the study has no direct comparator on that basis. The nearest mechanism neighbor is a Phase 2 CXCL2-targeting monoclonal antibody, eltrekibart, developed by Eli Lilly and Company, but for hidradenitis suppurativa rather than cervical disease. Activity around the CXCL2 target more broadly has thinned, with zero trials recorded in the recent period against seven in the prior period. The nearest indication-level precedents are HPV vaccine and screening programs rather than active topical treatments for existing lesions, underscoring that no validated non-surgical drug therapy exists for this specific disease stage. NCT07572396

This analysis was produced using AI-assisted reporting systems, AppliedXL data, and official public records. These systems undergo editorial review, quality checks, and regular audits by human experts. Errors may still occur, as with any automated system. Always consult the linked primary sources. Read our AI Editorial Policy.