Faron Pharmaceuticals Oy (LON:FARN) is enjoying momentum with its project pipeline as its COVID-19 candidate Traumakine has just received the green light to enter the final stage of trials in the US.
The Finnish drugmaker will test it on people who have been hospitalised but do not yet need ventilation and have not received corticosteroids.
The aim is to prevent systemic inflammatory response syndrome (SIRS) and acute respiratory distress syndrome (ARDS) – and by extension improve sufferers’ condition and reduce the death rate among patients.
In all, around 140 coronavirus sufferers will take part in Faron’s HIBISCUS study at five to ten sites in the US.
Traumakine, which is an interferon beta-1a, will be measured against a placebo, which has no medical impact on the patient.
The candidate has also attracted the interest of the US Department of Defense (DoD), which was revealed to be a surprise backer of the HIBISCUS study with a US$6.1mln cash injection.
Faron chief executive Dr Markku Jalkanen told Proactive the DoD is also interested in the drug to treat its soldiers when they suffer from combat wounds.
Hospitalised soldiers and COVID-19 patients have one thing in common: the potential to develop ‘cytokine storms’, which are inflammatory reactions that go out of control posing the risk of multiorgan failure and consequent death.
Traumakine was also part of the World Health Organisation's (WHO) Solidarity trial, however it was concluded that a subcutaneous formulation (when it’s injected under the skin), had little effect in halting coronavirus-related deaths.
Jalkanen told Proactive he was pleased, regardless of the outcome, because the WHO was able to confirm Faron’s theory that the drug was not effective in subcutaneous form.
Instead, it should work when delivered right into the vein (intravenous injection) so it can circulate across the body.
Faron’s other lead candidate, Clevegen, was recently discovered that it has even more potential that previously though.
Researchers assessed data from the phase I/II MATINS clinical trial of the treatment, which targets Clever-1, a receptor known to be expressed on immunosuppressive macrophages (cells that engulf and destroy other cells).
Firstly, it was found that the candidate showed early efficacy signs on cholangiocarcinoma, also known as bile duct cancer, alongside other four cohorts previously announced - cutaneous melanoma, colorectal cancer, hepatocellular cancer and ovarian cancer.
Secondly, it was found that a higher dosage of the drug could potentially work better on patients, so Faron is now studying how to increase it from every three weeks to every fortnight or week and a half.
This was revealed after the latest scientific observations shone some light on how Clever-1 works in suppressing the patient’s immune system.
While it waits for further data on the new discovery, Faron is discussing with potential partners but Jalkanen said a deal “has to reflect the real value of the Clevegen approach” and he’s not interested in clinching one “unless it brings real value”.
“It would be totally foolish to enter new partnerships unless they really would recognise the future upside of the product,” he added.
Meanwhile, the AIM-listed firm is mulling over a US listing: it’s already building a unit in Boston to facilitate interaction with the US Food and Drug Administration, has appointed an advisor and is reaching out to investors in the country but nothing has been decided as of yet.
With further data expected on Traumakine and Clevegen and growing interest in the US, 2021 is set to be a year to remember for Faron.
Shares jumped 6% to 421.25p on Tuesday afternoon.