Sirnaomics recently announced the positive 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 study examined six patients slated to undergo abdominoplasty, each injected with STP705 doses of 120 μg, 240 μg and 320 μg at volume per injection of either 0.5 ml or 1.0 ml per injection site, in addition to a placebo consisting of normal saline. Patients each received an injection in the central to lower abdomen region designated for abdominoplasty, with each receiving up to three injections total that were spaced out roughly 28 days apart.
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The initial safety review analyzed the presence and severity of Local Skin Reactions (LSR) including erythema, edema, bruising and the incidence (severity and causality) of any adverse events within a period of approximately 98 days. Per the report, the secondary analysis examined histological evidence of fat changes typically observed in fat tissue remodeling, including fat inflammation, panniculitis, fibrosis and fat necrosis, with the statistical analysis performed with non-parametric one-way ANOVA using Kruskal-Wallis test and Dunn's multiple comparison test.
Interim Results
42 tissue samples were collected from the participants for analysis. The interim results showed histological evidence suggestive of fat remodeling after various doses of STP705 with no significant adverse reactions reported. The histological scoring and panniculitis + fat necrosis ranking demonstrated a dose-dependent effect for all treatment groups compared to the placebo group with statistical significance (P < 0.05). The most significant results were observed in patients that received 240 μg at the volume of 1.0 ml.
Professor Mark Nestor, M.D., Ph.D., Director of the Center for Clinical and Cosmetic Research and the Center for Cosmetic Enhancement, Aventura, Florida, a Voluntary Professor in the Division of Plastic Surgery at the University of Miami, Miller School of Medicine and the principal investigator (PI) of the Phase I clinical study commented, "the initial data from the Phase I trial appears to indicate that the use of STP705 in the treatment of unwanted fat is safe and shows clear signs of efficacy. Safety has been examined in the first of three subjects and histology of the injected areas post abdominoplasty has been evaluated. Regarding histology, there is a clear difference in many of the specimens between the placebo, and the subjects injected with STP705. We look forward to completing this first study and analyzing all the results in the near future."
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"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 fat changes that would be observed in fat remodeling," said Michael Molyneaux, M.D., Executive Director and Chief Medical Officer of Sirnaomics. "The safety results were very encouraging 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-surgical fat 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."
RNAi Treatment for Non-Invasive Fat Remodeling
This is Sirnaomics’ first attempt at developing a RNAi therapeutic candidate for localized fat remodeling, with the positive interim results serving as a guide to navigating the later stage development of STP705 in the medical aesthetics category. Sirnaomics reported plans to use insights gained from this study to expand into the treatment of submental fat and other areas of noninvasive fat remodeling.
"The interim results of this Phase I clinical study have brought a strong enthusiasm using RNAi drug for medical aesthetic treatment. This novel non-invasive fat-reduction option potentially offers millions of people with unwanted fat on their bodies, which are resistant to diet and exercise and influenced by aging and genetics, a unique way to address those all-too-common conditions," said Patrick Lu, Ph.D., Founder, Chairman of the Board, Executive Director, President and Chief Executive Officer of Sirnaomics. "During our preclinical studies with a well-defined animal model, we found that STP705 demonstrated superior efficacy and safety, compared to a commercially available injection drug for the same indication. This observation encourages us not only to explore the utility of STP705 for medical aesthetics but also to advance it to become a best-in-class drug candidate for fat-remodeling."
