Sirnaomics, Inc. (www.sirnaomics.com), a leading biopharmaceutical company in discovery and development of RNAi therapeutics, announces today that the company had initiated a Clinical Phase IIa Study for its leading siRNA therapeutic candidate, STP705 (Cotsiranib®), for evaluation of the safety and efficacy of STP705 in human subjects with hypertrophic scar.
Sirnaomics lead product candidate, STP705, is an anti-fibrosis siRNA (small interfering RNA) therapeutic taking advantage of a dual-targeted inhibitory property and polypeptide nanoparticle (PNP)-enhanced delivery to directly diminish both fibrotic activity and inflammatory activity. These attributes will allow application in many disease states. This initial clinical study is designed to measure the safety, tolerability, and efficacy for treatment of Skin Hypertrophic Scars caused as a result of abnormal healing following surgical procedures. Currently, there are no pharmaceutical products for hypertrophic scarring approved by US Food and Drug Administration or European Medicines Agency.
"This first-in-man study of STP705 in USA will provide safety and efficacy evidence of Sirnaomics’ unique siRNA drug design and the PNP formulation for a novel antifibrotic therapeutic approach”, said the Founder and CEO of the company, Dr. Patrick Y. Lu, “The knowledge and experience from the intradermal injection of this siRNA therapeutic should pave a path towards utilizing this drug candidate systemically for other fibrotic disease treatments, addressing broader unmet clinical needs.”
“We are very excited to enter the clinic with STP705 in our first indication of hypertrophic scar. This IND approval serves as validation for our robust preclinical programs. We expect this rigorous clinical study design will enable us to gain great insights into the impact of STP705 on both fibrosis and inflammation and this information will enable us to greatly expand our platform and product pipeline for future disease indications”. The company’s chief medical officer, Michael Molyneaux, MD, and MBA, further emphasized.
About the planned Clinical Study
The study is a Phase IIa Randomized, Double-Blind Placebo Controlled Study to Evaluate the Safety and Efficacy of Various Doses of STP705 administered as intradermal injection in subjects with Hypertrophic Scar. Secondary Outcome measures will examine both patient and physician reported Scar outcomes with the use of validated Scar assessment tools.
About Hypertrophic Scar
Hypertrophic scar formation is a major clinical problem in the developing and industrialized
world. Burn injuries, traumatic injuries, and surgical procedures can give rise to exuberant
scarring that results in permanent functional loss and the stigma of disfigurement. Hypertrophic scars form as a result of aberrations in physiologic wound healing and may arise following any insult to the deep dermis. By causing pain, pruritus and contractures, excessive scarring significantly affects the patient’s quality of life, both physically and psychologically.
Pathophysiology of hypertrophic scars involves a prolonged inflammatory and proliferative phase of wound healing after injury. Among various cytokines promoting hypertrophic scar formation, TGF-β1 is known as a key regulator of the aberrant fibrogenic response, while COX-2 is a potent proinflammatory and proliferative mediator.
STP705 is composed of two siRNA oligonucleotides, targeting TGF-β1 and COX-2 mRNAs respectively, and formulated in nanoparticles with Histidine-Lysine Co-Polymer (HKP) peptide. Each individual siRNA was demonstrated to inhibit the expression of their target mRNAs and combining the two siRNA’s produces a synergistic effect that diminishes pro-fibrogenic factors. Molecular analyses of the effects of administering the combination demonstrated that the inhibition of these targets had effects on downstream gene products associated with fibrosis including: α-SMA, Col1A1, and Col3A1. Additional data suggests that reductions in TGF-β1 and COX-2 led to a proapoptotic effects in fibroblasts. These observations suggest that STP705 has the potential for broad application in many inflammatory and fibrotic driven disease states. The route of administration for STP705 for Scar Reduction will be via intradermal injection.
About Sirnaomics, Inc.
Sirnaomics, Inc., a leading privately held biopharmaceutical company for discovery and development of RNAi therapeutics, is a Delaware corporation headquartered in Gaithersburg, Maryland, USA, with subsidiaries in Suzhou and Guangzhou, China. The company’s mission is to alleviate human suffering and advance patient care in areas of high unmet medical need. Members of the senior management team have extensive experience in the biopharmaceutical, financial, clinical and business management arenas in both the USA and China and the company is supported with funding from private investors, corporate partnerships and government grants. Sirnaomics has developed a strong portfolio of intellectual property with an enriched product pipeline. The therapeutic areas of interest include anti-fibrotic and anti-inflammatory disease states as well as cancer amongst others.
Dr. Michael Molyneaux, MD, MBA
Chief Medical Officer
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