Asieris Pharmaceuticals has announced positive data indicating the Phase III trial of its cold light photodynamic drug-device combination Cevira (APL-1702) achieved its primary endpoint in participants with cervical high-grade squamous intraepithelial lesions (HSIL).

HSIL are precancerous lesions linked to human papillomavirus (HPV) that can lead to cervical cancer.  

The results were presented at the 2024 Society of Gynecologic Oncology (SGO) Annual Meeting in San Diego, US, which was held 16-18 March.

Cevira also demonstrated a tolerable safety profile. The therapy stimulates the body’s production of the photosensitiser protoporphyrin IX (PPIX), which selectively accumulates in tumour tissue, and upon exposure to specific wavelengths, triggers tumour cell apoptosis.

The primary endpoint, which evaluated the response rate six months after administering Cevira, showed a statistically significant improvement of 89.4% compared to the placebo group.  

The drug also showed an improved clearance rate of high-risk HPV16 and/or HPV18, with a 103.9% increase in the Cevira group compared to placebo. Cevira was developed through Phase I and II clinical trials by Norway-based Photocure ASA, with Asieris gaining commercialisation rights in July 2019.  

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The Phase III trial (NCT04484415) enrolled 402 HSIL patients, defining the primary endpoint of response as the conversion of cervical epithelial tissue pathology to normal, or the conversion to low-grade squamous intraepithelial lesion (LSIL) while achieving baseline HPV clearance. Long-lasting infection with certain types of HPV, a common sexually transmitted infection, is the main cause of cervical cancer. If left untreated, HPV can be linked to 95% of cervical cancer cases, according to the World Health Organization.  

The China-based biotech now plans to submit a new drug application for Cevira in Q2 2024, according to Asieris’ chief development officer Linda Wu. 

According to a report on GlobalData’s Pharma Intelligence Center, the number of cervical cancer cases in the eight major markets (UK, US, France, Germany, Spain, Italy, Japan, and urban China) will reach 123,846 by 2030. 

GlobalData is the parent company of Clinical Trials Arena. 

In the announcement accompanying the data, Linda Wu said: “The study not only demonstrates remarkable efficacy but also exhibits a favourable safety profile, offering a new powerful artillery for the national cervical cancer prevention and control system. 

“Additionally, we are making significant progress in product development overseas, aiming to bring this innovative treatment to more patients as soon as possible.” 

The company also has other cancer candidates in the pipeline. Earlier this year, a Phase II trial of its repurposed antibiotic drug APL-1202 achieved its primary endpoint in participants with muscular invasive bladder cancer (MIBC). The drug is already approved to treat oesophagal squamous cell carcinoma in China and is also being reviewed by the US Food and Drug Administration to treat the same type of cancer.