Sagesse Bio Accelerates Development of SGY-101 into clinical development for Targeted Fat Reduction in Aesthetic Medicine and Medical Dermatology

Sagesse Bio partners with industry leaders to advance SGY-101, a novel siRNA therapeutic for focal fat reduction and tissue remodeling, into clinical trials

Early clinical trials show SGY-101 was well-tolerated at all doses, concentrations, and volumes, demonstrating an excellent safety profile with minimal local skin reactions

DALLAS, TX / ACCESSWIRE / August 15, 2024 / Sagesse Bio, an early-stage pharmaceutical company in aesthetic medicine and medical dermatology with a focus on body contouring and focal fat reduction announces its plans to rapidly develop its lead asset SGY-101 with backing from Gore Range Capital LLC (Gore Range Capital), a leading healthcare investment firm and Sirnaomics LTD (Sirnaomics), a leader in RNAi technology. Gore Range Capital will contribute its expertise in the skin health industry and Sirnaomics will lend its cutting-edge RNAi technology to help accelerate the development of novel solutions to reduce or remodel undesirable pockets of fat.

Unlike many fast-growing consumer industries, medical aesthetics has proved highly resilient to economic downturns. The industry has been growing rapidly for the past twenty years, and long-term prospects remain strong, with projections indicating near double-digit growth rates through 2027. This sustained growth is fueled by strong consumer demand, demographic trends, continuous technological innovation, and significant investment activity.

Mr. Humberto C. Antunes, an internationally recognized executive in the skin health industry, is a co-founder of Sagesse Bio and a partner at Gore Range Capital. He previously served as the Chairman and CEO of Galderma. Mr. Antunes remarks, "The global Aesthetic Medicine market, currently valued at nearly US $20 billion, is expected to grow at a rate of 6%, with certain segments experiencing high single-digit or even low double-digit growth. This market estimate does not include new technologies focused on fat modulation or reduction. Given that commercially available focal fat reduction solutions do not fully meet the needs of patients and physicians, there remains significant untapped potential."

Sagesse Bio is excited to advance SGY-101 to the clinical stage-a potentially groundbreaking siRNA-based therapeutic designed to target focal fat reduction and tissue remodeling. 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.

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 providing superior outcomes by reducing unwanted adipose tissue and improving skin aesthetics. Besides, the science behind siRNA presents a more refined solution than currently available therapies. This pioneering treatment has the potential to revolutionize non-invasive body sculpting by effectively remodeling adipose tissue with targeted RNA interference technology, offering a novel and promising solution for medical aesthetics.

SGY-101 has been studied in over 100 clinical trial participants for various cutaneous skin conditions and has demonstrated an excellent safety profile, underscoring its potential as a safe and effective therapeutic option. In early studies, SGY-101 was well tolerated at all concentrations and volumes studied and demonstrated no material safety issues based on reporting of AEs, LSRs, and changes from baseline in vital signs, safety labs, and ECGs.

Recent 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 revealed very promising results. The study revealed 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 (LSRs).

• 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.

Dr. Mark S. Nestor, M.D., Ph.D., 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, shared his enthusiasm for the study's results. "The results for this Phase I clinical study are very encouraging for the potential use of SGY-101 for focal fat reduction. 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."

Frederick Beddingfield, M.D., Ph.D., who will serve as the Chairman of the Board stated, "Sagesse has a unique opportunity to take an injectable drug with a known safety record in over 100 subjects in clinical trials and quickly move into the clinic, studying focal fat destruction, and facial and body contouring, areas of high unmet need and of great interest to patients."

Dr Beddingfield is an internationally renowned dermatologist and expert in biopharma and the aesthetics industry, having led the development of global leading brands such as BOTOX®, JUVEDERM®, LATISSE® and KYBELLA®. He previously served as Chief Medical Officer of Allergan Medical and Kythera. At Kythera he developed and gained global approvals for KYBELLA® for submental fat reduction and the company was acquired by Allergan for $2.1B. He also served as Chief Executive Officer of Sienna Bio and Kira Pharmaceuticals. Currently, he serves on the board of directors of Cytrellis Biosystems, is on the Board of Trustees of Advancing Innovation in Dermatology and is a Voluntary Associate Clinical Professor of Medicine/Dermatology and clinical instructor and lecturer at the UCLA School of Medicine.

As the demand for noninvasive treatment modalities in medical aesthetics continues to grow, SGY-101 represents a significant advancement in meeting this high unmet need. Sagesse Bio is committed to furthering the development of SGY-101 and exploring its potential to transform the landscape of aesthetic medicine and medical dermatology.

About Sagesse Bio

Sagesse Bio is an early-stage pharmaceutical company utilizing RNAi technology to accelerate the clinical development of novel solutions to reduce or remodel undesirable pockets of fat. The company's lead compound, SGY-101, is IND-enabled and currently in Phase II clinical trials for other indications. Sagesse Bio aims to become the leading provider of therapeutic solutions for targeted fat reduction in both aesthetic medicine and medical dermatology.

Learn more at: Sagesse Bio

About Gore Range Capital

Gore Range Capital is a venture capital firm investing in early-stage healthcare businesses with a focus on skin health. Formed in 2015, Gore Range Capital blends the hands-on approach of operationally focused private equity with the early-stage guidance needed in venture capital. Gore Range Capital offers not just capital, but operational, clinical, and scientific expertise. The firm works closely with portfolio companies and industry leaders to bring skin health innovations to market, leveraging its team of experienced healthcare investors, renowned advisors, industry leaders, and domain-expert practitioners to provide strategic, financial and scientific expertise to its investments.

Learn more at: www.gorerangecapital.com

About Sirnaomics

Sirnaomics is a biopharmaceutical company focused on the discovery and development of innovative RNA therapeutics for indications with unmet medical needs and large market opportunities. Sirnaomics is the first clinical-stage RNA therapeutics company with a strong presence in both Asia and the United States. Based on its proprietary delivery technologies, including a polypeptide nanoparticle RNAi platform and GalNAc RNAi platform, GalAhead™, Sirnaomics has established an enriched drug candidate pipeline. The company has also had multiple successes with oncology applications through its clinical programs.

Learn more at: www.sirnaomics.com

Forward-Looking Statements

This press release contains forward-looking statements concerning the development and commercialization of Sagesse Bio's products, the potential benefits and attributes of such products, and the company's expectations regarding its prospects. Forward-looking statements are subject to risks, assumptions, and uncertainties that could cause actual future events or results to differ materially from such statements. These statements are made as of the date of this press release. Actual results may vary. Sagesse Bio undertakes no obligation to update any forward-looking statements for any reason.

Contact Information

Investors:
Jon Meneese
President and Chief Executive Officer
jmeneese@sagessebio.com

SOURCE: Sagesse Bio