Sirnaomics Ltd (HKG: 2257), a leading biopharmaceutical company focused on the discovery and development of RNAi therapeutics, has announced receiving a written response from the U.S. Food and Drug Administration (FDA) regarding the required Class C meeting for STP705, a treatment for in situ squamous cell carcinoma (isSCC).
The Class C meeting is intended to seek the FDA’s guidance on the proposed non-clinical and clinical development plans for the Phase II/III and Phase III clinical studies of STP705 in isSCC. The FDA has provided clear and specific recommendations for the revision of relevant studies and additional justification needed. In alignment with the FDA’s guidance, Sirnaomics has initiated the necessary preclinical studies.
STP705 is a siRNA (small interfering RNA) therapeutic that leverages dual-targeted inhibitory properties and polypeptide nanoparticle (PNP)-enhanced delivery to directly suppress both TGF-β1 and COX-2 gene expression. The product candidate has received multiple Investigational New Drug (IND) approvals from both the U.S. FDA and China’s National Medical Products Administration (NMPA) for the treatment of cholangiocarcinoma (CCA), non-melanoma skin cancer, and hypertrophic scarring. STP705 is currently under clinical study for isSCC, Phase II study for basal cell carcinoma (BCC), and Phase I study for focal fat remodeling. Additionally, the FDA has granted orphan drug designations (ODDs) for its use in CCA and primary sclerosing cholangitis (PSC).- Flcube.com
