Faron Pharmaceuticals Oy’s (LON:FARN) (NASDAQFIRSTNORTH:FARON) dual pipeline has taken a new direction during the coronavirus crisis.
Its candidate Traumakine is now part of a global trial for the treatment of Covid-19, but that does not mean that the other project, Clevegen, has been left behind.
In fact, the phase I/II MATINS study for Clevegen has recently been expanded.
The precision immunotherapy candidate was initially assessed for its efficacy for colorectal and ovarian tumours.
But following successful analysis on 30 people, the data monitoring committee (DMC) overseeing the trial has recommended the second stage be opened to all solid tumour groups on its list of targets.
The MATINS trial will now take in seven further strains of the disease.
Ten patients are expected to be treated in each of the next cohorts and the first colorectal group of the second stage has already been recruited.
“The DMC for the Clevegen MATINS trial actually endorsed the move on to these nine different cohorts as fast as possible,” chief executive Dr Markku Jalkanen told Proactive.
“The only way of moving it was for us to raise additional resources.”
That’s why in April, despite the widespread market crisis, Faron raised £12.18mln to use for Clevegen.
Faron, which has a double listing, issued 2.7mln Nordic placing shares at €4 per share, a discount of 7%, and UK placing shares at 348p per share, at a 12% discount.
Both were oversubscribed by new and existing shareholders, with The Fourth Swedish National Pension Fund upping its stake to 4.7% from 2.9%.
With the additional funds, Faron has enough cash to carry on for the next 12 months.
Some of the money will also be dedicated to the studies on Traumakine, an interferon beta-1a drug, in the treatment of Covid-19.
“The Traumakine trials are not cost-free for us but they are mostly funded from other sources,” Jalkanen pointed out.
Two coronavirus trials for Traumakine
The candidate has completed phase I/II of trials for the treatment of organ trauma and vascular damage, but is also involved in two studies focused on the coronavirus pandemic.
The first programme, announced on 1 April, is assessing its potential in treating severe pneumonia, including patients with Covid-19.
The Randomised, Embedded, Multifactorial Adaptive Platform Trial for Community-Acquired Pneumonia (REMAP-CAP) will study 6,800 patients across Asia-Pacific, Europe and North America, excluding the US.
The interferon beta-1a formulation will be delivered intravenously, which Faron reckons offers the best “delivery route” for critically ill patients.
It will also be compared in the study with other treatments, including hydrocortisone medications.
These steroid-based interventions, used in patients in respiratory distress, were seen as the potential root cause of a previously failed Faron phase III study of Traumakine.
Just weeks after the announcement on REMAP-CAP, Traumakine was also added to the World Health Organisation’s Solidarity trial.
Faron believes its interferon beta-1a drug may help protect against serious lung complications.
It is being administered in combination with the HIV drug lopinavir but, according to Jalkanen, “If it gets to the point where the leak is in the lungs then Traumakine, we believe, is the only drug that can help.”
The two will be compared with the current standard of care in order to assess efficacy, with early data being available as soon as this month.
Faron has donated supplies to treat 2,000 patients, although more people are included in the trial.
Licensing partners sought
The company continues to pursue partnering and licensing discussions for both Traumakine and Clevegen.
“Clevegen has shown very promising clinical response in MATINS Part I stage, which we believe will transform into significant opportunity when the study moves to the Part II-III expansion stages,” Jalkanen said.
“Traumakine, on the other hand, has a new corticosteroid-free setting through the global REMAP-CAP study, which we believe is one of the most important intensive care studies of the current pandemic environment.”
Since the beginning of the coronavirus crisis in the UK in mid-March, shares in the biotech have shot up 47% to 367p.