A preliminary observational study in Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) patients has been completed, which demonstrated that ME/CFS is associated with specific disturbances in metabolism. On the basis of this result, PharmaQest proposes that interventions designed to modulate specific metabolic pathways may be beneficial for the treatment of ME/CFS. The Company plans to raise capital to conduct a proof of concept efficacy study in ME/CFS patients.
ME/CFS is a term used to describe a heterogeneous disorder primarily characterised by persistent debilitating fatigue, both mental and physical, which often involves additional symptoms such as muscle pain and post-exertional malaise. ME/CFS is also associated with early death from cancer, heart failure and suicide. In the USA, the disorder is often referred to as Chronic Fatigue Immune Deficiency Syndrome (CFIDS). The underlying causes of this disease are currently unknown, but appear to involve mitochondrial dysfunction. A prior viral infection is also correlated with many cases of ME/CFS.
The prevalence of ME/CFS is approximately 0.4%, affecting predominantly young adults, with a higher incidence in females. ME/CFS affects more than one million people in the United States, and approximately 240,000 people in the UK. There is currently no marketed product that specifically treats the symptoms of ME/CFS. PharmaQest has filed a provisional patent for the ME/CFS project.
PharmaQest plans to conduct a proof-of-concept, placebo-controlled clinical study with ME/CFS patients in order to establish efficacy for the proposed treatment. No placebo-controlled study of this type has been conducted in ME/CFS patients.