Emergo Therapeutics is focused on developing drugs to modulate inflammatory cytokines and improve the functioning of the immune system in various potential indications, starting with infectious diseases. Emergo believes that inflammation caused by mast cells, a group of cells integral to innate immunity, is responsible for some of the most damaging symptoms and outcomes of seemingly unrelated diseases. A vast majority of these conditions are not treated with mast cell therapies, even though overwhelming evidence shows this would be therapeutically beneficial. Emergo’s therapeutic interventions are focused on reducing the production of inflammatory cytokines from mast cells.
Emergo’s lead program is the development of norketotifen for the treatment of uncomplicated influenza and influenza‑like illness. Norketotifen is the principal active metabolite of ketotifen, a known antagonist of the histamine H1 receptor and mast stabilizer. Ketotifen has been approved in over 95 countries worldwide, including the US and Europe, for the treatment of asthma and/or allergic conditions in children and adults. Norketotifen, however, has not been approved anywhere for any indication.
The mast cell stabilizing properties of norketotifen form the scientific rationale for its use in the treatment of influenza and influenza-like illness by Emergo. There is extensive agreement that the symptoms and pathology of influenza and many other respiratory viral infections are due to an excess release of pro-inflammatory cytokines. This has been clearly demonstrated in human studies where healthy subjects who were exposed to influenza A and went on to become symptomatic showed characteristic cytokine expression patterns. The link between cytokine expression and mast cells was further demonstrated in mouse infection models where mice lacking mast cells were found to be resistant to lung pathology and physiological impacts of influenza infection. These studies also show that mast cells are activated by all strains of influenza virus tested, making them a primary source of circulating cytokines during influenza infection.
Emergo has already completed all the scientific and commercial due diligence to reassure investors of the market potential for norketotifen in this lead indication. Animal pharmacology studies demonstrating the promise for norketotifen in the treatment of influenza and influenza-like illness and animal toxicology studies have also been completed to prepare for the use of norketotifen in humans. Clinical trials will be initiated in late 2018 with the view of demonstrating the potential for this therapy in a proof of concept Phase 2 study by 2020. If successful, this lead program would then be partnered with a capable larger pharmaceutical company that would complete the clinical trials and take this drug to market.
In addition to the lead program, Emergo will look for additional compounds to develop for a number of other conditions linked to mast cell dysregulation such as tumor lysis syndrome, diabetes and obesity, chronic fatigue syndrome, acute respiratory distress syndrome and others.