Arch Biopartners Receives No Objection Letter from Health Canada for PONTiAK Trial
Toronto, Canada, February 18, 2025 – Arch Biopartners Inc. (ARCH or the “Company”), a clinical stage biotechnology company, is thrilled to announce that the clinical team leading the upcoming investigator-led trial, titled “Prevention Of NephroToxin Induced Acute Kidney Injury with Cilastatin” (PONTiAK), has received a No Objection Letter (NOL) from Health Canada. This significant milestone allows the team to commence the trial, which is designed to evaluate the efficacy of Metablok, Arch’s NF-κB inhibitor, in preventing acute kidney injury (AKI) in patients undergoing cardiopulmonary bypass surgery.
What is Metablok and Acute Kidney Injury?
Metablok is a novel, synthetic, small-molecule inhibitor of NF-κB, which is a key mediator of inflammation. The drug has been shown to prevent inflammation and reduce organ damage in various preclinical models. Acute kidney injury (AKI), also known as acute renal failure, is a sudden and often reversible loss of kidney function. It can lead to a wide range of complications, including fluid and electrolyte imbalances, cardiovascular complications, and even death. AKI affects millions of people each year, especially those undergoing major surgeries or suffering from sepsis or other severe infections.
Impact on Individuals
For individuals undergoing cardiopulmonary bypass surgery, the risk of developing AKI is significant. In fact, up to 30% of patients undergoing this type of surgery experience some degree of kidney damage. Metablok’s ability to prevent AKI could lead to improved outcomes for these patients, reducing the need for dialysis and other costly treatments. Additionally, it could help reduce the risk of long-term complications, such as chronic kidney disease and cardiovascular problems.
Impact on the World
The global burden of AKI is substantial, with an estimated 13.3 million cases and 1.7 million deaths each year. The economic burden is also significant, with an estimated cost of $43.6 billion annually in the United States alone. Metablok’s potential to prevent AKI could have a profound impact on healthcare systems worldwide, reducing the need for costly treatments and improving patient outcomes. Furthermore, it could pave the way for the development of new therapies to treat and prevent other inflammatory conditions.
Conclusion
Arch Biopartners’ receipt of a No Objection Letter from Health Canada for the PONTiAK trial represents a significant step forward in the development of Metablok as a potential treatment for acute kidney injury. The drug’s ability to prevent inflammation and reduce organ damage could lead to improved outcomes for patients undergoing cardiopulmonary bypass surgery and reduce the global burden of AKI. As the trial gets underway, we will continue to monitor developments closely and provide updates as they become available.
- Arch Biopartners receives No Objection Letter from Health Canada for PONTiAK trial
- Metablok, a novel NF-κB inhibitor, has the potential to prevent acute kidney injury
- Cardiopulmonary bypass surgery patients are at high risk for AKI, affecting millions each year
- Improved patient outcomes and reduced healthcare costs are potential benefits of Metablok
