Sagesse Bio plans to rapidly develop SGY-101 with, a novel siRNA therapeutic for focal fat reduction and tissue remodeling.
The Company is partnering with Gore Range Capital LLC and Sirnaomics LTD to move the needle.
SGY-101 utilizes small interfering RNAs (siRNAs) to precisely target adipocytes, silencing the expression of TGF-β1 and COX-2 genes, both of which play critical roles in tissue inflammation, fibrosis, and the regulation of localized adipose tissue.
This dual-targeting approach is delivered via histidine-lysine nanoparticles, which stabilize the siRNA, ensuring accurate gene silencing and enhanced cellular uptake, the Company reports.
Unlike current therapies, SGY-101’s innovative mechanism addresses the overproduction of TGF-β1 and COX-2 genes in areas of excess adipose tissue formation, potentially reducing unwanted adipose tissue and improving skin aesthetics.
SGY-101 has been studied in more than 100 clinical trial participants for various skin conditions and has demonstrated an excellent safety profile. In early studies, SGY-101 was well tolerated at all concentrations and volumes studied and demonstrated no material safety issues.
Soon-to-be-published preclinical animal studies and Phase I clinical study evaluating the safety and tolerability of SGY-101 in adult subjects undergoing abdominoplasty showed the following key findings:
- Well-Tolerated: SGY-101 was well-tolerated at all doses, concentrations, and volumes administered.
- Excellent Safety Profile: The treatment demonstrated an excellent safety profile with minimal local skin reactions.
- Rare Adverse Reactions: Observed treatment-associated adverse reactions were rare and resolved without intervention.
- Efficacy in Adipocyte Destruction: Histologic analysis by an independent pathologist on excised tissue samples confirmed SGY-101’s activity in adipocyte destruction, occurring in a dose-response manner.
“The results for this Phase I clinical study are very encouraging for the potential use of SGY-101 for focal fat reduction,” says Mark S. Nestor, MD, PhD, Voluntary Professor at the University of Miami, Miller School of Medicine, Department of Dermatology and Cutaneous Surgery, and Department of Surgery, Division of Plastic Surgery in Miami, FL, in a news release. “This study generated compelling results for both the safety and efficacy of SGY-101 for fat reduction and remodeling. I am most excited about the extremely low incidence of localized skin reactions, which is the main concern for the current injectable fat reduction drug on the market.”
