On May 30, 2022 Sirnaomics Ltd. (the "Company" or "Sirnaomics", stock code: 2257.HK), a leading biopharmaceutical company in discovery and development of RNAi therapeutics, reported the launch of a Phase I clinical trial of the Company’s siRNA (small interfering RNA) drug candidate, STP705, in adults undergoing abdominoplasty for submental fat reduction (Press release, Sirnaomics, MAY 30, 2022, View Source [SID1234615232]). This study is the first application for Sirnaomics to apply an RNAi therapeutic candidate for medical cosmetology treatment.

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The global non-invasive fat reduction market size was valued at USD1.1 billion in 2021 and is anticipated to register a compound annual growth rate (CAGR) of 16.1% from 2022 to 2030, up to approximately USD4.0 billion (Grand View Research). Non-invasive fat reduction is a procedure that is done to decrease or eliminate stubborn fat pockets in specific areas of the body by using methods like cryolipolysis, radio frequency, and laser lipolysis. Non-invasive devices that are used in these procedures to permanently abolish fat cells are approved by the U.S. Food and Drug Administration (FDA) as their efficiency and safety have been tested and the results have been proven to show significant results. However, the market is currently dominated by devices that have mild therapeutic effects and require multiple treatment sessions. Sirnaomics will initially focus on the use of STP705 for submental fat reduction.

The dose-ranging, randomized, double-blind, vehicle-controlled study will enroll 10 patients to evaluate the safety and tolerability of STP705, which will be delivered via subcutaneous injection. The primary endpoints are to assess injection comfort, characterize local and systemic safety, and evaluate histological changes of subcutaneous doses of STP705, and to compare the safety and tolerability of three different concentrations of STP705 to select dosages for future studies.

"Submental fullness is a common condition that is resistant to diet and exercise and is influenced by multiple factors including aging and genetics," said Sirnaomics Executive Director and Chief Medical Officer Michael Molyneaux M.D. "Our goal in expanding our applications of STP705 with this study is to examine the safety and efficacy of this treatment in patients who are undergoing abdominoplasty. 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."

"The current devices and procedures for non-invasive fat reduction have mild therapeutic effects, and require multiple and sometimes challenging treatment sessions, which are costly for patients and don’t always achieve the desired results," said Dr. Patrick Lu, Founder, Chairman of the Board, Executive Director, President and CEO of Sirnaomics. "Based on a discovery from our previous clinical study and a series of preclinical evaluations with animal models, we decided to expand STP705 therapeutic application into medical aesthetics with this Phase I study."

About STP705

Sirnaomics’ leading product candidate, 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 COX2 gene expression. The product candidate has received multiple IND approvals from both the U.S. Food and Drug Administration (FDA) and the Chinese National Medical Products Administration (NMPA), including treatments of cholangiocarcinoma, non-melanoma skin cancer and hypertrophic scar. STP705 has also received Orphan Drug Designation for treatment of cholangiocarcinoma (CCA) and primary sclerosing cholangitis (PSC). STP705 is currently in five clinical trials for different indications: a Phase IIa for squamous cell carcinoma in situ (isSCC), a Phase II for basal cell carcinoma (BCC), a Phase I/II for keloid scarring, a Phase I/II for hypertrophic scar (HTS), and a Phase I for liver cancer (basket).