Faron Pharmaceuticals (LON:FARN) said 2015 was a “transformational year” for the business as it posted its financial and operational review of the period.
November saw the Finland-based life sciences firm list on the London Exchange, raising €14.2mln.
This along with €5.1mln pre-IPO funding has provided the business with enough cash to fund phase III clinical trials of its lead drug, Traumakine.
Faron has repurposed beta interferon (normally used to slow the progression of multiple sclerosis) to tackle condition called acute respiratory distress syndrome, or ARDS for short.
The company dosed its first patient in December and phase III study will take place over 55 hospitals in Europe.
Faron also teamed up with Maruishi Pharmaceutical Co to carry out phase II trials on Traumakine in Japan and data so far has been “encouraging”.
ARDS can affect people of any age and usually develops as a complication of an existing serious illness such as flu, pneumonia, sepsis or even severe trauma.
It is so serious that the mortality rate is between 30-45% and there is no recognised pharmaceutical treatment.
A study of 100 patients that received significant coverage in the Lancet medical journal revealed the Faron drug, called Traumakine reduced the death rate by 81%.
In the control group (so, those people who didn’t receive Traumakine) 32% died from ARDS.
That compares with an 8% in mortality rate in the tranche of patients that received the new treatment.
On the back of those results, Faron decided it would press ahead with a larger phase III trial to fully assess and stress test Traumakine’s efficacy.
ARDS is rare and there is no drug treatment for it.
This means Traumakine may be given orphan status, which provides a fast track to registration where there is an unmet medical need. Faron already has an orphan for Traumakine in Europe.
That said, Europe-wide there are 170,000 cases. In the US ARDS affects around 200,000 people annually.
The maths is simple. Analysts say if a six-day course Tramaukine is be priced at say 4,500 euros, which is around 1,000 euros more than it costs for a one-day stay in an intensive care unit, then the market in Europe alone is worth 765mln euros.
Add in the US – with potential sales of around 900mln euros a year – and suddenly you have drug with blockbuster potential (ie revenues of more than US$1bn, or 885mln euros a year).
It is hoped that Traumakine can provide a major saving to hard-pressed hospitals by cutting the number of days an ARDS patient spends in the ICU in half to just 14.
Remember each day in one of these high dependency units costs around 3,500 euros per day.
If Traumakine comes anywhere close to repeating the results published in the Lancet in phase III, Faron will have a truly extraordinary drug on its hands.
The other treatment in the company’s pipeline is Clevegen, which is designed uses the body’s own immune system to tackle cancer.
In December Faron received €1.5mln from a Finnish funding agency to bankroll pre-clinical development of this potential game-changing treatment.
It has collaborations with the Turku PET Centre, one of the largest positron emission tomography centres in Europe, and Swiss-based Selexis, which it hopes will help with the development of the cancer treatment.
The prelims, meanwhile, revealed Faron made an operating loss of €6.2mln for the 12 months to December 31 and was sitting on cash of €11.1mln.
Commenting on the progress last year, boss Dr Markku Jalkanen said it had been “transformational” period. “We are looking forward to making significant progress with these innovations to develop new treatments for these true unmet medical needs," he added.