“STP705 has demonstrated very robust results in pre-clinical animal efficacy studies and a very good safety profile. Based on the unique nature of RNAi technology, we have been able to target homologous RNA sequences across multiple species. The sequences and STP705 formulation that demonstrated very good safety and efficacy results in animal studies are expected to achieve similar compelling results in the human Hypertrophic Scar reduction studies,” said Dr. Michael Molyneaux, Chief Medical Officer of the company. “We expect to file IND to US FDA in early third quarter of 2016 and to initiate the phase 1 clinical study soon after the filing.”
“The PNP (polypeptide Nanoparticle) siRNA formulation of our leading drug candidate, STP705, had been extensively validated and shown to be very versatile with a simple straight forward manufacturing process,” said Dr. Marc Lemaitre, Sirnaomics’ Chief Operation Officer. “This nanoparticle formulation will allow for considerable optionality in treating and targeting many different types of human disease.”
About Fibrotic Diseases
Fibrotic disease encompass a wide array of clinical disease conditions from the systemic fibrotic diseases to organ-specific disorders including skin hypertrophic scar, liver, lung, kidney, and cardiac fibrosis. Although their causative mechanisms are quite diverse, these diseases share the common feature of prolong inflammation and uncontrolled accumulation of fibrous tissue macromolecules in affected organs leading to their dysfunction and ultimate failure.
Sirnaomics’ STP705 is an anti-fibrosis siRNA (small interfering RNA) therapeutic candidate, taking advantage of a dual-targeted inhibitory property and PNP-enhanced delivery to directly diminish the tissue fibrotic activity in various animal models, from skin hypertrophic scar to liver and lung fibrosis. A fully-developed manufacturing process and a well-established pre-clinical safety profile ensure STP705 for human clinical studies with a broad application potential.
Sirnaomics, Inc., a leading privately held biopharmaceutical company for discovery and development of RNAi therapeutics, is aDelaware corporation headquartered in Gaithersburg, Maryland, USA, with subsidiaries in Suzhou and Guangzhou, China. The company is pursuing the mission of advancing its proprietary technologies using pluripotent siRNA cocktail design and nanoparticle-enhanced therapeutic delivery to treat critical human diseases. Members of the senior management team bring over 100 years of combined experience in the biopharmaceutical, financial, clinical and business management in both USA andChina. Supported with funding from private investors, corporate partnerships and government grants, Sirnaomics has developed a strong portfolio of intellectual properties with an enriched product pipeline. The therapeutic areas of interest include anti-fibrotic medicine, cancer therapeutics, and others.