Grant: Project Grant

Opioids are needed to treat severe pain caused by inflammation or tumours, yet they are limited by their debilitating side effects and potential to cause addiction, which continues to devastate countless lives. We developed a novel analgesic drug that is only active at the site of inflamed tissues and tumours, where pain originates, because it targets their acidic environment. Elsewhere in the body (e.g., brain, gut, lungs), where there is no inflammation, the drug is inactive because there are normal physiological acid levels. Consequently, our drug not only lacks the addictive potential of conventional opioids, but also their side effects, including nausea, mental confusion, decreased breathing, and severe constipation. Unfortunately, the opioid crisis has discouraged investors from investing in pain research. In addition, some studies have shown that rodent findings don't always hold up in human studies. Investors understandably want greater assurance that the drug will work in humans before investing in expensive toxicology studies and clinical trials. To address these concerns, we will work with Health Canada-compliant companies to manufacture a drug product for studies in non-human primates (NHPs), setting the stage for future human studies. We have 3 key aims: 1) manufacture a drug product for our NHP studies that is compliant for future human toxicology, pharmacology, and clinical trial studies; 2) use this product to demonstrate drug efficacy, lack of addictive potential, and side effects in an NHP model, thereby de-risking the drug for human studies; and 3) develop a regulatory pathway with Health Canada to accelerate studies in humans. Research with drugs in NHPs has been shown to most closely approximate their effects in humans. Thus, showing efficacy, lack of addiction potential, and side effects in this model would boost investors' confidence in our drug and improve the funding success, thereby enabling us to proceed to human clinical trials.