MicroCures Awarded Grant for Therapeutic Platform for Accelerated Tissue Repair

MicroCures has been awarded a Phase 2 Small Business Innovation Research (SBIR) grant from the National Institutes of Health (NIH). The two-year, $1.5 million award will support ongoing development of the company’s lead product candidate, siFi2. siFi2, a small interfering RNA (siRNA) therapeutic that can be applied topically, is designed to enhance recovery after trauma. This Phase 2 grant continues the company’s successful Phase 1 SBIR contract which demonstrated significantly improved repair of burn wounds following treatment with siFi2 in animal models.

MicroCures’ technology is based on foundational scientific research at Albert Einstein College of Medicine regarding the fundamental role that cell movement plays as a driver of the body’s innate capacity to repair tissue, nerves, and organs. The company has shown that complex and dynamic networks of microtubules within cells crucially control cell migration, and that this cell movement can be reliably modulated to achieve a range of therapeutic benefits. Based on these findings, the company has established a first-of-its-kind proprietary platform to create siRNA-based therapeutics capable of precisely controlling the speed and direction of cell movement by selectively silencing microtubule regulatory proteins (MRPs).

The company has developed a broad pipeline of therapeutic programs with an initial focus in the area of tissue, nerve and organ repair. Unlike regenerative medicine approaches that rely upon engineered materials or systemic growth factor/stem cell therapeutics, MicroCures’ technology directs and enhances the body’s inherent healing processes through local, temporary modulation of cell motility. The company’s lead drug candidate, siFi2, is a topical siRNA-based treatment designed to silence the activity of Fidgetin-Like 2 (FL2), a fundamental MRP, within an area of wounded tissue. In doing so, the therapy temporarily triggers accelerated movement of cells essential for repair into an injury area. Importantly, based on its topical administration, siFi2 can be applied early in the treatment process as a supplement to current standard of care.

"We are grateful for NIH’s continued support of our work through this multi-year Phase 2 SBIR grant. This non-dilutive financial support allows us to continue building a robust portfolio of preclinical data in animal models that demonstrate the therapeutic potential of siFi2 to significantly improve and accelerate healing of burn wounds," said David Sharp, Ph.D., co-founder and chief science officer of MicroCures. "This funding will help advance our research as we work towards first-in-human clinical trial in 2020."

The initial Phase 1 SBIR grant from NIH funded preclinical research by MicroCures which demonstrated that treatment with siFi2 accelerated re-epithelization, improved collagen deposit and maturation, and improved quality of healing in a porcine full thickness burn model. Specific findings showed that following eight weeks of treatment, 39% of siFi2-treated wounds were closed as compared to only 11% for control subjects and 0% for placebo. Additionally, siFi2-treated subjects demonstrated a significantly improved rate of healing as measured by epithelial surface measurements as compared to placebo (p = 0.0106) and control (p = 0.0012).

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