Cutasil is an siRNA therapeutic that improves skin wound healing with minimized scar formation.

Sirnaomics won its fifth NIH Small Business Innovation Research (SBIR) grant, with the latest award intended to develop the company’s small interfering RNA (siRNA) therapeutic product STP705 (Cutasil®), designed to improve skin wound healing with minimized scar formation.

The firm says the new SBIR funding, of an undisclosed amount, will further enhance the company’s effort to perfect its nanoparticle-based siRNA delivery systems and speed up what it said were “intensive” IND-enabling studies in both the U.S. and China.

Cutasil is one of four siRNA therapeutic product candidates developed through three generations of nanoparticle-based siRNA delivery systems—self-assembled nanoparticles, ligand-directed nanoparticles, and infrared-activated nanoparticles. The other three products are STP601 for treatment of ocular AMD/diabetic retinopathy, STP702 for treatment of respiratory influenza viral infection, and STP909 for treatment of HPV infection/cervical cancer. In addition, Sirnaomics said it is developing drug candidates for several other therapeutic indications. 

Founded in 2007, Sirnaomics hopes to be the first drug developer internationally to launch a marketed siRNA pharmaceutical drug that will accelerate the rate of wound closure while reducing the scar that typically forms in adult skin, decreasing the strength of the repair.

Sirnaomics said its research to date has demonstrated that accelerated wound closure with a topically applied siRNA mixture results in wound repair and a return of normal skin morphology without a scar and with return of follicles—a therapeutic benefit superior to existing standard treatment.

“This product will have utility in treatment of wounds incurred on the battlefield, wounds from burns, or wounds from surgical intervention and may have utility in treatment of diabetic wounds—many of which require limb amputation as a cure. This product can be positioned within the armed forces for battlefield medical use, within hospitals for traumatic wounds and eventually into clinics and plastic surgery offices to improve healing in elective surgery,” Sirnaomics said in the statement.

Sirnaomics has estimated the market for reduction of scarring on skin at about $4 billion a year, with some 42 million surgery-patients in the U.S. each year potentially benefiting from the pharmaceuticals that can improve wound healing and minimize scar formation. According to the company, there are 70 million surgical procedures annually in the U.S., and another 41.8 million each year in Europe involving skin wounds.

Cutasil, packaged in HK polymer nanoparticles, targets both transforming growth factor beta (TGFβ1) and Cox-2, an enzyme responsible for inflammation and pain. Cutasil has been tested in mouse and swine skin excision wound models, where it was seen to have accelerated wound closure, minimized scar formation, and decreased pain with anti-fungi activity.

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