Sirnaomics Doses the First Patient in Phase I Clinical Trial of RNAi Therapeutic STP705 in Adults Undergoing Abdominoplasty for Medical Aesthetics Treatment

2022.11.07

 Data results expected to be available in 1H 2023

 Gaithersburg, MD, USA and Suzhou Biobay, China, November 7, 2022 — Sirnaomics Ltd. (the “Company” or “Sirnaomics”, stock code: 2257.HK), a leading biopharmaceutical company in discovery and development of RNAi therapeutics, announced today that the Company has dosed the first patient in a Phase I clinical study of STP705, a siRNA (small interfering RNA) drug candidate, for the study of fat reduction in adults undergoing abdominoplasty. In this clinical trial, Sirnaomics has the opportunity to study a leading siRNA therapeutic candidate for medical aesthetics treatment.

 

The dose-ranging, randomized, double-blind, vehicle-controlled study has 10 patients currently enrolled to evaluate the safety and tolerability of STP705, which is administered 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. The safety and tolerability will be compared among three different concentrations of STP705 (120ug/mL, 240ug/mL, 320ug/mL) to select dosages for future studies.

 

“Currently, the majority of non-invasive procedures approved in the U.S. to abolish fat cells require devices that have mild therapeutic effects and multiple treatment sessions. Our team expects that this dose finding study of STP705 will give key insights into the drugs’ effect on fat reduction and subcutaneous tissue remodeling and provide key insights into how this therapeutic can be applied in a safe and effective manner to Medical Aesthetics.” said Dr. Michael Molyneaux, M.D., Executive Director and Chief Medical Officer of Sirnaomics. “This Phase I study will help us mapping out future studies of STP705 for areas of the body that could be treated with non-invasive methods of fat sculpting.”

 

Non-invasive fat reduction is a procedure that decreases or eliminates stubborn fat pockets in specific areas of the body by using methods like cryolipolysis, radio frequency, and laser lipolysis. The global market size of non-invasive fat reduction was valued at US$1.1 billion in 2021, with the U.S. having the largest market share, and is anticipated to have an annual growth rate of 16.1% [1] from 2022 to 20301. The Asia Pacific region is expected to outgrow the rest of the world at a pace of 17% over the same period due to factors such as rising obese population, increasing healthcare expenditure, increasing adoption of advanced technology and rising awareness by social media platforms.

 

“A non-invasive fat-reduction option will potentially offer millions of people with submental fat, which is resistant to diet and exercise and influenced by aging and genetics, a unique way to address an all-too-common condition,” said Dr. Patrick Lu, Founder, Chairman of the Board, Executive Director, President and CEO of Sirnaomics. “After receiving the green light on an IND in the U.S., we look forward to better understanding how efficacious STP705 can be as a medical aesthetics treatment.”

 

Additional information about this clinical trial is available at clinicaltrials.gov using the identifier: NCT05422378.

 

[1]  Grand View Research (2022), Non-invasive Fat Reduction Market Size Report, 2022-2030.

 

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 COX-2 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 seven clinical trials for different indications: a Phase IIb 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), a Phase I/II for facial isSCC, a Phase I for liver cancer (basket), and a Phase I for medical aesthetics treatment.

 

About Sirnaomics

Sirnaomics is an RNA therapeutics biopharmaceutical company with product candidates in preclinical and clinical stages that focuses on the discovery and development of innovative drugs for indications with medical needs and large market opportunities. Sirnaomics is the first clinical-stage RNA therapeutics company to have a strong presence in both China and the United States, and also the first company to achieve positive Phase IIa clinical outcomes in oncology for an RNAi therapeutic for its core product, STP705. Learn more at www.sirnaomics.com.

 

CONTACT:

Michael Molyneaux, M.D., MBA

Executive Director and Chief Medical Officer, Sirnaomics

Email: MichaelMolyneaux@sirnaomics.com

 

Investor Relations:

Nigel Yip, MBA

Chief Financial Officer, China, Sirnaomics

Email: NigelYip@sirnaomics.com

 

US Media Contact:

Mark Corbae

Tel: +1 203 682 8288

Email: Mark.Corbae@westwicke.com

 

Asia Media Contact:

Bunny Lee

Tel: +852 3150 6707

Email: sirnaomics.hk@pordahavas.com