In early April 2023, the kick-off meeting for the clinical trial of the IDT-001 was successfully held at the Third Xiangya Hospital of Central South University. This kick-off meeting also marked the official initiation of the IDT-001 Phase III clinical trial (Protocol ID: IDT-001-CLN-01) into the subject enrollment stage.
The clinical trial is jointly led by Professor He Qingnan and Professor Lu Jianyun from the Third Xiangya Hospital of Central South University, who serve as the principal investigators nationwide, with approximately 27 research centers participating across the country. At the launch meeting, Professor Lu Jianyun provided a detailed introduction and training on the clinical trial, covering aspects such as the drug, protocol highlights, project plan, project standard operating procedures (SOPs), and related systems. Detailed answers were also provided to questions that may arise during the on-site clinical expert trial operation.
The meeting was successfully concluded as planned, and the IDT-001 Phase III clinical trial officially entered a new stage. Currently, the IDT-001 Phase III study is progressing rapidly, and it is expected that approximately 10 research centers will initiate Phase III clinical trials by the end of April 2023. The initiation of clinical trials at all centers is expected to be completed by the end of May.
IDT-001-CLN-01 is a multicenter, randomized, open-label, blinded evaluation, positive drug (mupirocin ointment) controlled Phase III clinical registration study to evaluate the efficacy and safety of IDT-001. The indication for this study is primary or secondary skin and soft tissue infections. Currently, in this treatment area, the recommended topical products in clinical practice are only mupirocin ointment and fusidic acid ointment, with mupirocin ointment being regarded as the "most ideal topical antimicrobial drug." IDT-001 demonstrates significant improvements in efficacy, safety, and compliance compared to mupirocin ointment, greatly fulfilling the unmet clinical needs in the field of skin and soft tissue infections.
Figure: Launching Meeting of Phase III Clinical Trial of Yuxi Pharmaceutical IDT-001 Project at Xiangya Third Hospital of Central South University
About Indetek
Indetek is a research-driven company that specializes in innovative drug development in the field of dermatology. The company has a global market focus and aims to address unmet needs in the field of skin diseases, aspiring to become a leading global specialist pharmaceutical company in dermatology. Indetek builds its product portfolio around the ILDS® transdermal technology platform, which is based on proprietary intellectual property. This platform significantly improves the efficacy, safety, and compliance of active pharmaceutical ingredients. The therapeutic areas covered by Indetek' products include skin and soft tissue infections, acne, hair loss, and hyperpigmentation, among others, filling gaps in specific market segments.
