MSI-1436 is a Novo Biosciences lead drug candidate. It is a readily synthesized, natural aminosterol that inhibits protein tyrosine phosphatase 1B (PTP1B) with high in vivo selectivity. PTP1B deactivates multiple cell signaling pathways that function normally to trigger regeneration.
Our studies show that by inhibiting PTP1B, MSI-1436 dramatically stimulates repair and regeneration of multiple tissues damaged by injury in zebrafish and mice. With the support of Direct to Phase II Small Business Innovation Research (SBIR) funding from the National Institutes of Health, Novo Biosciences is pursuing the development of MSI-1436 for treatment of heart damage caused by acute heart attack. MSI-1436 is also being tested for treatment of chronic heart injury, Duchenne muscular dystrophy, skeletal muscle injury and spinal cord damage.
MSI-1436 has been greatly derisked compared to many drug candidates. It has undergone extensive toxicity testing and was approved by the FDA for clinical trials in 2007 and 2015 as a potential treatment for obesity, type 2 diabetes and breast cancer. Doses of MSI-1436 that stimulate regeneration in animal models are 50 times lower than those that are well tolerated by patients.