Shengnuo Pharmaceutical-B (02257) issued an announcement. The company has obtained information from the US Food and Drug Administration (FDA)...
Zhitong Finance App News, Shengnuo Pharmaceutical-B (02257) issued an announcement. The company has obtained a written response from the US Food and Drug Administration (FDA) on its Class C meeting on its requirements for further development of STP705, a novel siRNA therapy for the treatment of squamous cell carcinoma in situ (ISSCC).
The purpose of the requested Class C meeting is to obtain FDA advice and opinions on proposed non-clinical and clinical development plans to prepare for phase II/III and phase III clinical studies to treat isSCC. In response to the company's recommendations and issues relating to related non-clinical studies and clinical study design, the FDA has provided clear and specific guidance for non-clinical and clinical studies, revisions to proposed phase II/III and phase III clinical studies, and further evidence needed to use the two active ingredients in the drug candidate STP705. Currently, the company has initiated the required preclinical studies in accordance with FDA guidance recommendations.
Dr. Lu Yang, founder, chairman of the board, executive director, president and CEO of Sirnaomics, said, “We are very grateful to the FDA for its specific guidance and recommendations at the level of trial details, which will make the development process of our novel siRNA therapy platform more efficient in the later stages of clinical development. I believe that preclinical studies relating to clinical dosage regimens, several revisions to the proposed phase II/III study, and other related work will provide a solid foundation for STP705 follow-up phase III clinical studies for non-melanoma skin cancers.”