Sirnaomics Announces Positive Phase I Clinical Data for STP705 in Focal Fat Reduction and Advances Program to Phase II

The group is advancing the project toIIPhase Clinical Study2023Data presented at the Fall Clinical Dermatology Conference

Hong Kong, Germantown, Maryland, and SuzhouNovember 1, 2023/PR Newswire/ -- Sirnaomics Ltd. （"Our Company", Stock Code: 2257.HK, together with its subsidiaries, collectively referred to as"This Group"Or"Sirnaomics"Sirnaomics, Inc. (a leading biopharmaceutical company dedicated to the discovery and development of RNAi therapeutics), announced that positive clinical data for STP705 in focal fat reduction (FFR) was presented at the 2023 Fall Clinical Dermatology Conference held in Las Vegas from October 22 to 25. The safety and efficacy results from this Phase I study support further research into the potential use of STP705 as an alternative to other FFR injectables.

The poster title published by Dr. Mark S. Nestor's team from the Aventura Clinical and Cosmetic Research Center in Florida isPhase I Study to Evaluate the Safety and Tolerability of Subcutaneous Injection of STP705 in Adult Subjects Undergoing Abdominoplasty(Phase I Study to Evaluate the Safety and Tolerability of STP705 Subcutaneous Injection for Abdominal Fat Reduction in Adult Subjects). Poster Summary: This Phase I study aims to explore the safety and tolerability of STP705 for abdominal fat reduction in patients, while preliminarily observing STP705-induced apoptosis of adipocytes to achieve fat reduction efficacy.

SirnaomicsFounder, Chairman of the Board, Executive Director, President and CEO, Dr. Yang Lu"Phase I data results for STP705 using RNAi injectable drugs for localized fat reduction are encouraging. The low incidence of localized skin reactions, along with histological observations showing adipocyte destruction and fat remodeling, strongly suggest that STP705 could be an optimal candidate for localized fat reduction, warranting further research."

The results include:

The study protocol includes 3 treatment cycles with a 28-day interval for drug administration. Each treatment cycle requires 7 subcutaneous injections, including STP705 doses of 120 μg, 240 μg, or 360 μg in 0.5ml and 1.0ml volumes (per injection), as well as a 1.0ml placebo. Patients are randomized in a double-blind manner and injected at 7 sites on the lower abdomen, each 1cm apart.²The area was injected. Eight subjects aged 18 to 65 received the injection and were followed up 2 days and 7 days after the procedure.

Tissue samples were collected from seven injection sites in the full abdominal lipectomy specimens obtained 28 days after the final injection, with safety assessments (including LSR evaluation) conducted throughout the study and all adverse events recorded. The lipolytic and inflammatory effects of STP705 were evaluated through blinded histological analysis of the collected tissue samples, and each sample was given a histological score based on the degree of observed inflammatory response.

SirnaomicsExecutive Director and Chief Medical OfficerMichael MolyneauxM.D."This clinical study’s results are very encouraging as STP705 has demonstrated potential for localized fat reduction. We continue to observe good safety profiles of this drug candidate, and the patient outcomes in this study are highly consistent with the results we observed in our non-clinical fat reduction research. The demand for non-invasive treatment options remains high, and with the continuous growth of aesthetic medicine needs, this product could perfectly align with the current trend in non-invasive cosmetic treatments."

MD, Department of Dermatology and Cutaneous Surgery, Division of Plastic Surgery, Miller School of Medicine, University of Miami, Volunteer ProfessorMark S. NestorPh.D."We presented the final data of the Phase I study at the Fall Clinical Dermatology Conference. As a researcher and clinical dermatologist, I am very excited about the safety and efficacy of STP705 in fat reduction and reshaping. What excites me the most is the extremely low incidence of localized skin reactions, which is a major issue with currently available injectable fat-reduction drugs on the market."

For more information about Sirnaomics clinical trials, please visit the company website.www.sirnaomics.com。 

AboutSirnaomics Ltd. (Stock Code: 2257)

Sirnaomics is an RNA therapeutics biopharmaceutical company with product candidates in both clinical and preclinical stages, focusing on exploring and developing innovative drugs for the treatment of indications with significant medical needs and large market opportunities. Sirnaomics is the first clinical-stage RNA therapeutics biopharmaceutical company to have a significant market presence in both Asia and the United States. With its proprietary delivery technologies — the Peptide Nanoparticle (PNP) delivery platform and the second-generation GalNAc conjugate delivery platform — the company has established a highly robust pipeline of drug candidates. Following multiple successes in the clinical programs for STP705 and STP707, Sirnaomics has taken an international leading position in advancing RNAi therapeutics for cancer treatment. STP122G is the first GalAhead™ technology candidate to enter clinical development. With the establishment of Sirnaomics’ clinical production facilities, the company is now transitioning from a biotech firm to a fully integrated biopharmaceutical company. For more information about the company, please visit:www.sirnaomics.com。