GAITHERSBURG, Md., May 19, 2026 (GLOBE NEWSWIRE) -- Amplexd Therapeutics, Inc. (“Amplexd”), a U.S.-based clinical-stage biotechnology company focused on women’s health and underserved therapeutic areas, today announced authorization from the Hong Kong Department of Health to initiate a Phase 2 clinical trial evaluating its novel EGCg-based investigational therapy for precancerous cervical lesions associated with high-risk human papillomavirus (hr-HPV).
High-risk HPV is the primary driver of cervical cancer, which remains a significant public health burden in the US and around the globe.
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.
The investigational therapy is a proprietary formulation containing epigallocatechin gallate (EGCg), developed as a vaginal suppository for self-administration at the site of disease.
“In the US, roughly 5% of cervical screenings reveal abnormalities1, the majority of which are low-grade,” said Alia Rahman, Chief Executive Officer of Amplexd. “These lesions are typically managed through increased surveillance known as ‘watchful waiting’ rather than active treatment, while advanced disease stages often require surgical interventions that are not uniformly accessible across healthcare settings. Despite the meaningful psychosocial and financial burdens associated with this approach, therapeutic advancements have been limited, and a significant unmet medical need for localized, non-surgical therapies remains. 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.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.
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.
Forward-Looking Statements
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.
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Amplexd Therapeutics, Inc.
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1 Evans KK, Tambouret RH, Evered A, Wilbur DC, Wolfe JM. Prevalence of abnormalities influences cytologists’ error rates in screening for cervical cancer. Arch Pathol Lab Med. 2011 Dec;135(12):1557-60. doi: 10.5858/arpa.2010-0739-OA. PMID: 22129183; PMCID: PMC3966132.
