MetaBlok is a new drug candidate and potential treatment for inflammation, sepsis and cancer metastasis.
Management of Arch believes Metablok has the potential to be a major breakthrough in the treatment of diseases where inflammation plays a major role, as well as in sepsis and cancer metastasis. Arch is currently pursuing further clinical development of Metablok and expects to make additional disclosures as milestones toward a human trial are completed over the next few months.
MetaBlok was invented by Arch scientists Dr. Stephen Robbins, Dr. Donna Senger, Dr. Jennifer Rahn and their University of Calgary colleague, Dr. Paul Kubes. The inventors have assigned the Metablok intellectual property to the Company.
U.S. Patent Issuance for Metablok
In October 2016, the U.S. Patent and Trademark Office (USPTO) issued U.S. Patent 9,464,114 titled, “Peptides that Block Leukocyte Recruitment and Methods of Use”. This is the first patent issued protecting the composition and method of use for Metablok.
Inflammation Based Disease
Inflammation is a localized physical condition that involves the activation of the immune system in response to infection, tissue injury, or autoimmunity. Inflammation is involved in the pathogenesis of many diseases and contributes to organ dysfunction and failure, such as certain types of acute kidney injury.
Sepsis represents a large unmet medical need in the world today. Sepsis alone occurs in 1 to 2% of all hospitalizations in the US. It affects at least 700,000 individuals per year.
Sepsis is a serious illness caused by the body’s immune response to an infection. White blood cells, or leukocytes, defend the body against toxins and infection. If the immune system activates too many white blood cells to fight the infection, there is a risk of widespread, life threatening inflammation termed “Sepsis”.
Sepsis is known to cause organ damage. Blood clotting during sepsis inhibits blood flow to organs and thus reduces their intake of nutrients and oxygen. In severe cases, one or more organs fail. In the worst cases, infection leads to a dangerous drop in blood pressure, called septic shock. This can quickly lead to the failure of several organs such as lungs, kidneys and liver, causing death.
Permanent organ damage can occur in patients who survive sepsis. Under current standard of care, mortality rates are over 20% for sepsis and over 50% for septic shock.
Cancer is a life threatening disease because of its ability to spread from its original tumour site to other tissues and organs in the body. This process of metastasis occurs through the bloodstream or lymphatic system.
Metastasis is of great importance since most of the cancer deaths are caused by spread of the primary cancer to other sites in the body. Recent evidence shows that 60% to 70% of patients have started the metastatic process by the time of diagnosis. Additionally, patients that do not have tumor spread at diagnosis are at risk for metastatic disease. New therapeutic treatments that protect patients against metastasis would be a major breakthrough in the treatment of cancer.
Human Trial and Drug Application Plans for Metablok
In pre-clinical studies, Arch scientists have demonstrated Metablok’s ability to prevent acute kidney injury by blocking the inflammatory response triggered by kidney ischemia/reperfusion. Currently, there are no specific or effective treatments to prevent acute kidney injury.
In November 2017, the Company engaged Nucro Technics in Scarborough, Ontario. Nucro-Technics performed initial toxicology, including a maximum tolerable dose and pharmacokinetic studies for Metablok, to support a pre- Investigational New Drug (IND) meeting with the U.S. Food and Drug Administration (FDA) planned for late Q1 or early Q2 in 2018.
Following the pre-IND meeting with the FDA, Arch intends to submit the IND application to enable a Phase I human clinical trial. Once approved, the Phase I trial will be designed to evaluate Metablok’s safety and pharmacokinetic profile in advance of future clinical trials to test its efficacy in treating or preventing acute kidney injury caused by inflammation.
Arch is currently arranging toxicology, chemistry, manufacturing and clinical planning to support the IND application to the FDA by approximately the end of the third quarter of 2018.