Sirnaomics Reports Interim Results of STP705 Phase I Clinical Study for Medical Aesthetics Treatment in Adults Undergoing Abdominoplasty
HONG KONG,GERMANTOWN,Md. and SUZHOU,China,June 5,2023 -- Sirnaomics Ltd. (the "Company",Stock Code: 2257.HK,together with its subsidiaries,the "Group" or "Sirnaomics"),a leading biopharmaceutical company in discovery and development of RNAi therapeutics,today announced the interim results of an ongoing Phase I clinical trial of STP705,an siRNA (small interfering RNA) drug candidate,for fat reduction in adults undergoing abdominoplasty. The initial results of the Phase I trial appear to indicate that the use of STP705 in the treatment of unwanted fat is safe and show clear signs of efficacy.
This interim efficacy results examined efficacy data from six participants that werescheduled to undergo abdominoplasty. Each participant was treated with STP705 doses of120 μg,240 μg and 320 μg at volume per injection of either 0.5 ml or 1.0 ml per injectionsite as well as placebo consisting of normal saline. The test article administration areawas the central to lower abdomen region designated for abdominoplasty and participantsreceived a single injection per site up to three injections of test article approximately 28days apart. Participants in the safety review were examined for the presence of and severityof Local Skin Reactions (LSR) including erythema,edema,and bruising over a time frameas well as the incidence (severity and causality) of any adverse events for a time frame ofapproximately 98 days. Secondary analysis looked at histological evidence of fat changesthat would be seen in fat tissue remodeling such as fat inflammation,panniculitis,fibrosisand fat necrosis. Statistical analysis was performed with non-parametric one-way ANOVAusing Kruskal-Wallis test and Dunn's multiple comparison test.
The interim analysis results include data from six participants with 42 tissue samples in total. There were no significant adverse events and all tissue samples examined in thisreview using variables doses of STP705 showed histological evidence suggestive of fatremodeling. Based on the histological scoring and panniculitis + fat necrosis ranking,adose-dependent effect was observed for all treatment groups comparing to the placebo groupwith statistical significance (P < 0.05). The 240 μg at the volume of 1.0 ml treatment grouphas demonstrated the most potent activity.
Professor Mark Nestor,M.D.,Ph.D.,Director of the Center for Clinical and CosmeticResearch and the Center for Cosmetic Enhancement,Aventura,Florida,a VoluntaryProfessor in the Division of Plastic Surgery at the University of Miami,Miller School ofMedicine and the principal investigator (PI) of the Phase I clinical study commented,"theinitial data from the Phase I trial appears to indicate that the use of STP705 in the treatmentof unwanted fat is safe and shows clear signs of efficacy. Safety has been examined in thefirst of three subjects and histology of the injected areas post abdominoplasty has beenevaluated. Regarding histology,there is a clear difference in many of the specimens betweenthe placebo,and the subjects injected with STP705. We look forward to completing this firststudy and analyzing all the results in the near future."
"Interim data from our clinical study of STP705 for fat reduction indicate that subjects that have received various doses of STP705 show clear histologic evidence of fatchanges that would be observed in fat remodeling," said Dr. Michael Molyneaux,Executive Director and Chief Medical Officer of Sirnaomics. "The safety results were veryencouraging with no systemic adverse events and no significant local skin or tissue changes.This finding is very important when selecting a product that will be used for non-surgicalfat remodeling and the fact that there was clear histological evidence of fat remodeling in a dose dependent manner is very encouraging as we move into Phase II of the program. We anticipate final study report sometime in Q3 2023 after which time,we will request a meeting with the FDA to determine the path to approval for the program."
This study is the Group's first exploration to apply an RNAi therapeutic candidate forlocalized fat remodeling and Sirnaomics plans to use the information from this study toexpand into the treatment of submental fat and other areas of noninvasive fat remodeling.The positive interim results have better informed the Group about the later stagedevelopment of STP705 in the medical aesthetics category. Together with the positiveresults from STP705 for treatment of squamous cell carcinoma in situ (isSCC) and basal cellcarcinoma (BCC),the Group has successfully leveraged the proof-of-concept human datafrom STP705. This advancement in fat remodeling is expected to open up a new therapeuticarea of medical aesthetics for Sirnaomics' pipeline and has received very positive responsesfrom the market.
"The interim results of this Phase I clinical study have brought a strong enthusiasm usingRNAi drug for medical aesthetic treatment. This novel non-invasive fat-reduction optionpotentially offers millions of people with unwanted fat on their bodies,which are resistantto diet and exercise and influenced by aging and genetics,a unique way to address thoseall-too-common conditions," said Dr. Patrick Lu,Founder,Chairman of the Board,Executive Director,President and Chief Executive Officer of Sirnaomics. "During ourpreclinical studies with a well-defined animal model,we found that STP705 demonstratedsuperior efficacy and safety,compared to a commercially available injection drug for thesame indication. This observation encourages us not only to explore the utility of STP705for medical aesthetics but also to advance it to become a best-in-class drug candidate forfat-remodeling."
Additional information about this clinical trial is available at clinicaltrials.gov using theidentifier: NCT05422378.
About STP705
Sirnaomics' leading product candidate,STP705,is a siRNA (small interfering RNA)therapeutic that takes advantage of a dual-targeted inhibitory property and polypeptidenanoparticle (PNP)-enhanced delivery to directly knock down both TGF-β1 and COX-2gene expression. The product candidate has received multiple IND approvals from boththe U.S. Food and Drug Administration (FDA) and the Chinese National Medical ProductsAdministration (NMPA),including treatments of cholangiocarcinoma,non-melanomaskin cancer and hypertrophic scar. There are currently three product pipeline advancingprograms prioritized by STP705: a Phase IIb for squamous cell carcinoma in situ (isSCC),a Phase II for basal cell carcinoma (BCC) and a Phase I for the fat remodeling. In addition,in the treatment of other indications,STP705 has received Orphan Drug Designation for thetreatment of cholangiocarcinoma (CCA) and primary sclerosing cholangitis (PSC).
About Sirnaomics Ltd. (Stock Code: 2257)
Sirnaomics is an RNA therapeutics biopharmaceutical company with product candidates inpreclinical and clinical stages that focuses on the discovery and development of innovativedrugs for indications with medical needs and large market opportunities. Sirnaomics is thefirst clinical-stage RNA therapeutics company to have a strong presence in both Asia andthe United States. Based on its proprietary delivery technologies: Polypeptide NanoparticleFormulation and the 2nd generation of GalNAc conjugation,the Group has establishedan enriched drug candidate pipeline. Sirnaomics is currently holding a leadership positionon advancing RNAi therapeutics for oncology application with multiple successes of itsclinical programs for STP705 and STP707. STP122G represents the first drug candidateof GalAhead™ technology entering clinical development. With the establishment of theGroup's manufacturing facility,Sirnaomics currently is undergoing a transition from abiotech company to a biopharma corporation. Learn more at: www.sirnaomics.com.
