Asieris Reveals Cevira Phase III Age Group Analysis at 2024 CSCO Meeting

OSLO, Norway, Sept. 30, 2024 – Photocure ASA, known as the Bladder Cancer Company, has announced significant findings from its partner Asieris Pharmaceuticals regarding the non-surgical treatment candidate Cevira® (APL-1702) for cervical High-Grade Squamous Intraepithelial Lesion (HSIL). The data from a Phase III clinical study were presented as a poster at the 27th Chinese Society of Clinical Oncology (CSCO) Annual Meeting. The focus of this presentation was the analysis of different age subgroups concerning six-month pathological regression rates and HPV clearance rates.

The Phase III clinical trial was prospective, randomized, double-blind, and placebo-controlled, conducted across multiple centers. The study successfully met its primary efficacy endpoint and demonstrated a favorable safety profile.

In terms of pathological regression rates, defined as the proportion of subjects whose condition regressed to Cervical Intraepithelial Neoplasia grade 1 (CIN1) or normal tissue at the six-month mark, notable improvements were observed. Specifically, in the age groups "≥20 and <30 years" and "≥30 and <40 years," the Cevira group showed a 15% to 20% higher regression rate compared to the placebo group. Notably, no events of cervical cancer were reported within these populations, indicating that Cevira holds substantial therapeutic potential for treating HSIL in women aged 20 to 40.

Regarding HPV clearance rates, the Cevira group demonstrated significant improvements in the overall HPV clearance rate, HPV16-positive clearance rate, and HPV16/18-positive clearance rate in the "≥20 and <30 years" age group compared to the placebo control group. The sample sizes for the "<20 years" and "≥40 years" age groups were limited, necessitating further studies with larger cohorts to validate these findings comprehensively. Overall, the results suggest that Cevira not only aids in the regression of HSIL to Low-Grade Squamous Intraepithelial Lesion (LSIL) but also facilitates the clearance of high-risk HPV infections.

Cevira® (APL-1702) is a photodynamic drug-device combination product designed for non-surgical treatment of high-grade squamous intraepithelial lesions in patients aged 18 and above, excluding carcinoma in situ. The product relies on photodynamic therapy principles, using a photosensitizer in conjunction with light activation to achieve therapeutic effects. Cevira was initially developed by Photocure through Phase I and II trials. In 2019, global rights for its development and commercialization were out-licensed to Asieris Meditech Co., Ltd. The Phase III clinical trial for APL-1702 began in November 2020 and reached its primary endpoint in September 2023. The National Medical Products Administration (NMPA) accepted the new drug application for APL-1702 in May 2024.

Photocure ASA, headquartered in Oslo, Norway, focuses on delivering innovative solutions to improve the lives of bladder cancer patients. Their technology, which makes cancer cells glow bright pink, has led to better health outcomes globally. Photocure is publicly traded on the Oslo Stock Exchange (OSE: PHO).

Asieris Pharmaceuticals, founded in March 2010, specializes in discovering, developing, and commercializing innovative drugs for treating genitourinary tumors and related diseases. The company is publicly listed (688176.SH) and pursues a global approach to advancing medical treatments in their field.

This compact presentation of the study highlights the potential of APL-1702 in treating HSIL and encourages further validation studies, particularly for broader age groups.