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Summit Therapeutics edging towards huge 'inflection point'

Published: 13:28 17 Nov 2015 GMT

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Summit is nearing the start of key phase 2 trials
Biotech Summit Therapeutics (LON:SUMM is edging closer to a huge 'inflection point', which could potentially transform its fortunes.
That's the view of chief executive Glyn Edwards, referring to data, which will follow the start of what he called a "crunch" phase 2 study for the firm's SMT C1100 drug for Duchenne muscular dystrophy (DMD) - the fatal muscle wasting disease mainly affecting boys.
 
This key trial is expected to start before the end of this calendar year and first data is expected in the middle of 2016.
 
The candidate has already shown "spectacular" results in animal models, in modifying the disease, and the firm hopes these will be replicated in these first human trials – so they are highly significant.
 
"It's an exciting period that has the potential to transform the future of the company," said Edwards, who explained that the study will be an open label one, enrolling up to 40 patients aged between 5 and 10 at sites in Europe and in the US.
 
The 48 week trial will look at biopsy samples from the boys looking at muscle strength and involve testing how far they can walk in six minutes.
 
Alongside this, the company continues to evaluate the timing and design for a larger, placebo-controlled trial of SMT C1100.
 
Indeed, the coming year promises to be a 'data rich' period as has been the case so far in 2015 for Summit, and the share price has reflected this progress, rising to around the 117p mark currently, having stood at just 7.41p in the summer of 2014.
 
Also expected in the group's fourth quarter (November to January) is top line data from ongoing phase 2 studies of the firm's other programme - an antibiotic for hospital super-bug C- diff - SMT19969.
 
Recent data presented by the firm supported the potential of this product to treat infection and reduce cases of it reoccurring - significant since up to 30% of patients after an initial episode risk catching it again.
 
Edwards said investors should look out for recurrence rates in the firm's phase 2 data.
 
"Our drug is the first of a new type of antibiotic that is exquisitely selective. It's very potent against the C-diff bacteria that cause the disease but what it doesn't do is cause any collateral damage to the good bacteria that you want to still is in the gut. That means that we expect we'll have a much lower recurrence rate," he said.
 
The medical need for both Summit's programmes is not in question. DMD is classified as an orphan drug and there is currently no treatment available. There are 50,000 sufferers in the developed world and sufferers rarely live beyond their twenties.
 
Summit's candidate is designed to regulate the level of utrophin, a protein naturally present in the body, in the hope utrophin may be able to make up for the lack of dystrophin in boys with DMD since both appear to have very similar functions.
 
The continued expression of utrophin has been shown to have a positive effect on the performance of muscles, and modulating it has the potential to slow down or even stop the progression of the disease.
 
Meanwhile, in 2012, there were 1,646 deaths from C-diff in England and Wales, and in the US, it is estimated that C-diff- related acute care costs of total of US$4.8 billion each year.
 
The infection, seen often in hospitals, can result in serious disease complications including bowel perforationand sepsis, and prove fatal in the most severe cases.
 
According to official stats, CDI is responsible for 14,000 deaths per year in the USA.
 
House broker N+1 Singer is optimistic about Summit's prospects.
 
It forecasts revenues to begin in the 2017 year, at £21.5mln leading to an adjusted pre-tax profit of £2.7mln and adjusted earnings per share of 7.7p.
 
The broker particularly looks forward to data from the SMT19969 this fourth quarter, not least as the drug has shown superior potency in a pre-clinical setting to approved antibiotics -  vancomycin and metronidazole -  and comparable potency to fidaxomicin.
 
So these are exciting times for Summit and investors.

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