Sirnaomics has initiated a Phase I clinical trial of its small interfering ribonucleic acid (siRNA) drug candidate, STP705, in adults who undergo abdominoplasty for submental fat reduction.
A lead product candidate of the company, the siRNA therapeutic STP705 leverages a dual-acting inhibitory property and polypeptide nanoparticle-enhanced delivery to directly destroy TGF-β1 and COX2 gene expression.
The dose-ranging, randomised, double-blind, vehicle-controlled trial will enrol ten subjects to assess the safety and tolerability of the subcutaneous dose of STP705.
Evaluating injection comfort and characterising local and systemic safety are some of the primary endpoints of the trial.
The primary endpoints also include analysis of histological changes of STP705 administered as a subcutaneous injection and comparing the safety and tolerability of three separate concentrations of the drug to select dosages for future trials.
Sirnaomics noted that the trial is the first to use an RNAi drug candidate for medical cosmetology treatment.
Sirnaomics executive director and chief medical officer Michael Molyneaux said: “Submental fullness is a common condition that is resistant to diet and exercise and is influenced by multiple factors, including ageing and genetics.
“We hope to use the information from this study to expand into the treatment of submental fat reduction and other areas of non-invasive fat sculpting.
“This Phase I study will serve as a blueprint for future studies of STP705 in the medical aesthetics category.”
Apart from this Phase I trial, STP705 is presently being analysed in five other trials for various indications.
These trials include a Phase IIa for squamous cell carcinoma in situ, a Phase II for basal cell carcinoma, two Phase I/II studies for keloid scarring and hypertrophic scar, respectively, as well as a Phase I study for liver cancer.
In April last year, the company dosed the first healthy participant in the Phase I trial of STP707 for treating liver fibrosis in primary sclerosing cholangitis in the US.
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