Grant: Project Grant

This commercialization project addresses the unmet medical need to diagnose and treat preterm birth (PTB, birth <37 weeks) and to commercialize relevant new products. PTB is the #1 health problem of pregnancy. There are no reliable products available to diagnose or treat it. New breakthrough discoveries provide the first-ever opportunity to combine a PTB diagnostic and therapeutic within one new company, Maternica. The Olson lab developed a new test, the leukocyte migration assay, or LMA, that predicts delivery within 7 days with 96% accuracy. The Chemtob lab developed an anti-inflammatory therapeutic that blocks the action of interleukin-1, rytvela. They share a common mechanism; hence the LMA is the perfect tool to indicate the need to treat with rytvela for PTB risk and improved fetal outcome. Our primary objective is to complete the pre-clinical and regulatory requirements to advance our commercialization program towards FDA/Health Canada 510 K (device) and Investigational New Drug (IND) approval of LMA and rytvela for clinical prediction and prevention of PTB. We will test the LMA and rytvela together in a non-human primate (monkey) model and how responsive the LMA and rytvela are to each other. We will also test promising analogs to rytvela to confirm that the present formulation is the most efficacious, expand our intellectual property profile and provide backups. Once we clear these hurdles, new investors for clinical trial phases will be attracted. In the first 1.5 years we will complete our pre-clinical testing of the products, and in the second 1.5 years will prepare the data and presentation materials for discussions with FDA/Health Canada. Then Maternica will proceed to the necessary clinical trials. Maternica will seek permission for orphan drug designation and a breakthrough designation for accelerated approval. Experienced CEO, P Douville, and CBO, D Richter, will guide these developments.