Leveraging a team of highly experienced individuals to facilitate unmet clinical needs
ReFormation Pharmaceuticals Corp is a Pharmaceutical company headquartered in Toronto, Canada with Research and Development operations at the University of Oxford. ReFormation focuses on an innovative approach to repair vital organs by targeting an endogenous trigger of repair (HMGB1).
Cardiovascular disease is the leading cause of mortality in the Western World.2
720,000 Americans will suffer from an MI this year and approximately 50% will have a recurrent event.3
While most patients now survive the initial heart attack, many go on to develop heart failure as the damaged muscle heals with scar tissue.
Healthcare expenditure for heart failure in the USA exceeds $30 billion and is expected to increase to $70 billion by 2030, yet 5 year survival is only ~60%, worse than most cancers.4
There is currently no approved treatment for improving heart regeneration following MI (a heart attack).5
ReFormation’s preliminary data shows that a single injection of HMGB1 leads to more than 50% improvement in heart function and similar reduction in damaged tissue in a mouse model.
The average time for a person to reach hospital in the USA following a heart attack is 3 hours and many heart attacks occur after presentation to hospital. Our preliminary data show that HMGB1 promotes regeneration if given up to 4 hours after injury.
Therefore, there is compelling evidence that HMGB1 should be developed for treating people after a heart attack and that this represents a huge commercial opportunity for ReFormation.
Type 1 diabetes affects approximately 1 in 300 people under the age of 18 years in the USA and accounts for 10% of all causes of diabetes.7
Current treatment relies on administration of insulin and fails to address the underlying problems.
Whilst there are multiple on-going trials for products that would reduce the autoimmune damage, there is currently no treatment to promote beta cell regeneration.
In collaboration with a team at the University of Oxford, ReFormation have initiated studies in a mouse model of type 1 diabetes to assess the regenerative potential of HMGB1 on pancreatic beta cells.
If successful, ReFormation will elucidate the mechanism of action of action of HMGB1 in collaboration with a team from the University of Cambridge using mice where the beta stem cells have been labelled with a fluorescent marker.
Parkinson’s disease is the second most common neurodegenerative disorder, and will affect nearly 1 million people in the USA by 2020 and is estimated to increase to 1.24 million individuals by 2030.8
Current treatment relies on replacing the chemical (l-DOPA) that is secreted by the brain cells lost in patients with Parkinson’s disease. However, this is largely supportive and patients continue to deteriorate.9
A group at Vanderbilt University in Nashville have formed a sister company, Unify Pharmaceuticals, which have compelling data in monkeys that a novel antioxidant compound has remarkable efficacy in reducing the damage to the neurones.
We will assess the efficacy of combination therapy with HMGB1. If effective, this will provide proof of concept data to allow us to progress to clinical trials in patients.
Following proof of efficacy in Parkinson’s disease, we will be well placed to investigate the regenerative effects of HMGB1 for Alzheimer’s disease.
Non-alcoholic fatty disease affects ~25% of the US population.
Approximately 60% of patients with non-alcoholic fatty liver disease (NAFLD) go on to develop non-alcoholic steatohepatitis (NASH) and 25% of these develop liver cirrhosis, equating to 1.5-2% of the total population.10
Many of the major pharma companies are investing large sums of money to develop new treatments for a condition that is now considered a global epidemic.
ReFormation will develop combination therapies by promoting liver regeneration using HMGB1 whilst at the same time reducing damage.
Combination therapy with HMGB1 should lead to enhanced liver regeneration, whilst limiting damage with other modalities.