Photocure ASA (OSE: PHO) and its partner Asieris Pharmaceuticals (SSE (LON:SSE): 688176) announced on Wednesday that their multinational Phase III clinical trial for Cevira (APL-1702) has successfully met its primary endpoint. Cevira, a photodynamic drug-device combination product, is in development for the non-surgical treatment of high-grade squamous intraepithelial lesions (HSIL).
The prospective, randomized, double-blind, placebo-controlled international multicenter Phase III clinical trial was designed to evaluate the efficacy and safety of APL-1702 for treating cervical HSIL. The study, led by Academy Member Dr. Jinghe Lang from Peking Union Medical College Hospital, Chinese Academy of Medical Sciences, enrolled 402 participants and demonstrated a robust safety profile alongside meeting its primary objective.
Comprehensive data from the study will be presented at upcoming academic conferences and published in scientific journals. The results will also be submitted to the Chinese National Medical Products Administration (NMPA) as part of a new drug application (NDA) in the upcoming months.
Dr. Linda Wu, Chief Development Officer of Asieris Pharmaceuticals, highlighted the significance of this milestone in managing HSIL and its potential to transform care in this domain. She emphasized Asieris Pharmaceuticals' commitment to advancing China's Action Plan to Eliminate Cervical Cancer (2023-2030) and contributing to Healthy China 2030.
Anders Neijber, Photocure's Chief Medical Officer, expressed excitement over the successful completion of the Phase III clinical trial for Cevira. He emphasized the potential benefit to many patients globally who could use a non-surgical approach to treating HSIL.
According to Global Cancer Statistics 2020, cervical cancer ranks as the fourth most prevalent malignancy among females worldwide, with 604,127 new cases and 341,831 deaths.
This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.