Asieris Pharmaceuticals (Asieris) today announced dosing of the first patient in Europe in its multinational, multicenter, Phase III clinical trial (APRICITY) of its photodynamic drug-device combination product APL-1702, Cevira? which is being developed for a novel non-surgical treatment of cervical high-grade squamous intraepithelial lesions (HSIL).

HSIL is a pre-cancerous condition caused by a persistent HPV infection. Each year there are approximately 10 million cases of high-grade disease and over 500,000 new cases of cervical cancer worldwide. In China, approximately 2% of women develop HSIL each year.In 2019, the number of women with precancerous cervical lesions in China was approximately 3.5 million, and the compound annual growth rate from 2015 to 2019 was 1.3%. With wider use of cervical cytology and HPV screening, more cervical lesions are detected at precancerous stage, and the number of diagnosed patients is expected to continue to rise in the future. Conventional surgical treatment may cause adverse reactions like bleeding, infection, and organic injury of the cervix, which may cause a series of reproductive dysfunctions such as premature delivery and miscarriage. Currently, no non-surgical approach is available for the treatment of precancerous cervical lesions globally. 

In China, the clinical trial application for APL-1702, Cevira? multinational Phase III trial was approved by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) in July 2020, and the first patient was dosed in November.

"As a local non-surgical treatment option, APL-1702, Cevira? has clear advantages in its safety profile over surgical treatment, which helps patients, especially women of childbearing age, to avoid surgery and its related complications," according to Dr. Xue Yong, MD, PhD, Chief Medical Officer at Asieris. "We will endeavor to accelerate the clinical trial progress and bring this potential novel therapy to patients globally."

About APRICITY trial

APRICITY is a multinational, multicenter, randomized, double blind, prospective, placebo-controlled phase III clinical trial to evaluate the efficacy and safety of APL-1702, Cevira? in HSIL. The Cevira? treatment is an integrated combination of drug and device. The device is a single-use, disposable, LED-based red-light source. The device will automatically switch on the light 5 hours after administration, and provide continuous photoactivation of 125 J/cm2 over 4.6 hours before automatically shutting down. The placebo device is identical in appearance as the Cevira? device, but does not provide light. Primary Outcome Measures the proportion of responders at 6 months after first treatment. Female patients of 18 years to 85 years are eligible for the trial. This trial is currently open for recruitment. More details can be found at clinicaltrials.gov, with identifier, NCT04484415.

About Asieris

Asieris Pharmaceuticals, founded in March 2010, is a global innovative pharma company specializing in new drugs for the treatment of genitourinary tumors and other major diseases. We strive to improve human health and help people live a more dignified life. We aim to become a global pharma leader that integrates R&D, manufacturing and commercialization in our areas of focus, as we provide best-in-class integrated diagnosis and treatment solutions for patients in China and worldwide.The company has been developing its proprietary R&D platform and core technologies, exploring new mechanisms of action, and efficiently screening and evaluating drug candidates. With a well-established in-house R&D system and expertise in global drug development, Asieris is committed to launching first-in-class drugs and other innovative products to address huge unmet needs in its areas of focus. Asieris is also enhancing its pipeline for genitourinary diseases via proprietary R&D and strategic partnerships, while closely following cutting-edge technologies and therapeutics. The company strives to discover and identify unmet clinical needs, and adopts a forward-looking approach in product planning and life-cycle management. We aim to establish an outstanding portfolio that covers diagnosis and treatment in a bid to benefit more patients in China and globally.