High-risk HPV is the primary driver of cervical cancer, which remains a significant public health burden, particularly across the Asia-Pacific region. High-risk HPV prevalence amongst Chinese women is estimated at 12.8%[1] with China representing 23% of cervical cancer cases globally[2].
The randomized, placebo-controlled Phase 2 study is being conducted at The Chinese University of Hong Kong in collaboration with Prince of Wales Hospital, with recruitment currently underway. The study will evaluate the safety and efficacy of Amplexd’s investigational therapy in women diagnosed with ASC-US and low-grade squamous intraepithelial lesions (LSIL) alongside confirmed hr-HPV infection. Clinical data are expected in Q1 2027.
Amplexd’s investigational therapy is a proprietary, shelf-stable vaginal suppository formulation containing epigallocatechin gallate (EGCg), a bioactive compound derived from green tea, designed for localized self-administration at the site of disease.
“Currently, there is a significant unmet medical need for localized, non-surgical therapies specifically indicated for low-grade lesions associated with high-risk HPV. The standard of care is largely limited to increased surveillance and ‘watchful waiting,’ which can impose both psychosocial and financial burdens on patients,” said Alia Rahman, Chief Executive Officer of Amplexd. “Moreover, in many resource-constrained settings including large swaths of Asia-Pacific, access to surgical intervention and specialized follow-up care is limited. Previously published, peer-reviewed clinical and preclinical studies have explored the use of EGCg-based topical formulations in the treatment of HPV and cervical lesions. Building on this body of research, we developed a shelf-stable formulation designed for self-administration and early therapeutic intervention.”
The Phase 2 trial will evaluate endpoints including lesion regression, viral clearance, and overall safety profile, with the goal of generating data on the potential for early therapeutic intervention in hr-HPV-associated disease.
Additional information about the study can be found at www.drugoffice.gov.hk under trial identifier eCTS-2026-021 and at www.clinicaltrials.gov under trial identifier NCT07572396.
Important Information
This clinical trial has been authorized by the Hong Kong Department of Health. Participation will be subject to eligibility criteria and informed consent. This investigational therapy has not been approved by the U.S. Food and Drug Administration, and its safety and efficacy have not been established.
This press release contains forward-looking statements regarding clinical development plans and potential benefits of the investigational therapy. These statements involve risks and uncertainties that could cause actual results to differ materially. Amplexd Therapeutics, Inc. undertakes no obligation to update these statements except as required by law.
Cervical Cancer Incidence and Mortality Trends in China: The Role of Screening,
Cancer Letters, Volume 642 (2026) 218286, ISSN 0304-3835. https://doi.org/10.1016/j.canlet.2026.218286.
Hashtag: #AmplexdTherapeutics #hrHPV #HPVtherapy #HPV #cervicaldysplasia #LSIL #ASCUS #Phase2clinicaltrial #womenshealth #EGCg #cervicalcancer #investigationaltherapy #clinicaltrial
The issuer is solely responsible for the content of this announcement.
About Amplexd Therapeutics, Inc.
Amplexd Therapeutics, Inc. is a biotechnology company pioneering science-driven therapies for women’s health and related diseases with high unmet need. Its pipeline leverages novel mechanisms and accessible delivery modalities to expand treatment options for patients.
