Sirnaomics and Partner Submit IND to CFDA
Sirnaomics, Inc. and its affiliate Suzhou Sirnaomics Pharmaceutics, Co. Ltd., together with its partner Guangzhou Xiangxue Pharmaceutical, Co. Ltd., (SZSE: 300147), have formally submitted an Investigational New Drug (IND) Application to the China Food and Drug Administration (CFDA) for STP705, an anti-fibrosis RNA interference (RNAi) therapeutic for prevention and treatment of human skin hypertrophic scars. STP705 consists of two small interfering RNA (siRNA) sequences (targeting two genes critically involved in fibrogenesis) packaged in a proprietary polymer nanoparticle (PNP) formulation for delivery. The anti-fibrogenic activity of STP705 has been validated in human hypertrophic scar implant models and in mouse and pig skin excisional wound and burn models.
Fibrogenic diseases including liver, lung and kidney fibrosis, as well as skin hypertrophic scarring, are diseases with limited therapeutic options. The therapeutic potential of STP705 in skin hypertrophic scar prevention and treatment addresses a large market need for skin scar treatment. Each year, approximately 42 million surgical procedures are performed in the US (The Nemetz Group in 2009) resulting in about 62 million scars (CDC). Furthermore, many patients experience hypertrophic scarring and keloids after surgery – with higher percentages observed in emerging countries. It is estimated that 93 million people in the US are living with scars, and about 169 million scars can be characterized as hypertrophic or keloid (Frost & Sullivan).
Sirnaomics is a leading biopharmaceutical company focused on the discovery and development of RNAi therapeutics. Based on its proprietary technologies using multi-targeted siRNA cocktail design and nanoparticle-enhanced therapeutic delivery, Sirnaomics has developed a rich pipeline of siRNA therapeutic product candidates, including STP705, STP702 for respiratory viral infection, STP909 for HPV/Cervical Cancer, STP302 for Colon Cancer and has active research programs in other therapeutic arenas.
Sirnaomics has signed a partnership with Guangzhou Xiangxue Pharmaceuticals in 2011 with a primary goal to advance STP705 into the clinic.
“The IND submission by Sirnaomics with our partner and its formal acceptance by CFDA mark a major advancement of our endeavor to develop siRNA drugs in China.” said the Founder and President of the company, Dr. Patrick Y. Lu.” The clinical studies with first-in-class innovative siRNA therapeutic STP705 will provide us with a confirmation of a unique drug design and formulation and will validate our novel approach to preventing and treating hypertrophic scars during routine surgical procedures”. STP705 is the first siRNA therapeutic candidate subject of IND filing as a type 1.1 [innovative] new drug in China.
“Although the regulatory hurdles to develop novel therapeutics in China are much more challenging than what we expected, we are committed to move forward with a clinical study of STP705 in China.” commented Dr. Marc Lemaitre, Sirnaomics, Inc. CEO. “Further, with a parallel IND filing for STP705 to the US FDA in preparation, we envision starting Phase I clinical study in both countries soon”.
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 develop novel therapeutics to alleviate human suffering and advance patient care in areas of high unmet medical need. The guiding principles of the company are: Innovation, Global Vision with a Patient Centered focus. Members of the senior management team have a great deal of combined experience in the biopharmaceutical industry, financial, clinical and business management in both the USA and China. The company is supported by funding from institutional investors and corporate partnerships. Sirnaomics has developed a strong portfolio of intellectual property with an enriched product pipeline. The therapeutic areas of focus include oncology and anti-fibrotic therapeutics. Learn more at www.sirnaomics.com.