The company expects to report interim clinical data of the Phase 2 study in the second half of 2021.

Sirnaomics, Inc. dosed the first patient in a Phase 2b study of the company's drug candidate, STP705, for the treatment of squamous cell skin cancer in situ (isSCC). 

The company expects to report interim clinical data of the Phase 2 study in the second half of 2021.

STP705 is a siRNA (small interfering RNA) therapeutic that takes advantage of a dual-targeted inhibitory property and polypeptide nanoparticle (PNP)-enhanced delivery to directly knock down both TGF-β1 and COX-2 gene expression. 

The randomized, double-blind, placebo-controlled Phase 2b study is evaluating the safety and efficacy of intralesional injection of STP705 in up to 100 adult patients with isSCC. This part of the trial will further evaluate the two most efficacious dosing regimens of 30 ug and 60 ug. The primary endpoint of this trial is the proportion of participants with histological clearance of treated isSCC lesion at the end of treatment. Histological clearance will be defined as the absence of detectable evidence of isSCC tumor cell nests as determined by central pathology review.

"For many patients with isSCC, surgery is still considered the only viable treatment option, so with our first patient dosed in this Phase 2b study, we'll be able to observe the efficacy of STP705, which has to the potential to be a non-surgical, non-invasive alternative," says Michael Molyneaux M.D., Chief Medical Officer of Sirnaomics, in a news release. "Our interim readout later this year will guide our clinical development for this indication."   

"After a high rate of patients achieved histological clearance in the Phase 2a study of STP705 for isSCC, we're looking forward to seeing the results of our Phase 2b study as we begin patient dosing," adds Patrick Lu, Ph.D., founder, President and CEO of Sirnaomics. "The anticipated clinical readout in the second half of 2021 will provide more insights into the potential of STP705 for the treatment of non-melanoma skin cancer and the impact of RNAi therapeutics in oncology."

Additional information about this clinical trial is available at clinicaltrials.gov using the identifier: NCT04844983.