A phase III trial of the drug in patients with the lung inflammation condition ARDS proved a major disappointment, with Traumakine proving no more effective than a placebo.
But further analysis of the data showed a “substantial reduction” in mortality in a certain subgroup of ARDS patients – those with a C/T mutation, which is carried by one-in-three Europeans.
A second phase III study is now planned, subject to approval from regulators and external funding.
“We have made a number of important discoveries whilst analysing the Traumakine INTEREST data during 2018 which have allowed us to not only believe that there is definitely a future for Traumakine in the treatment of ARDS, but also determine the next steps in its development, including the design of the phase III CALIBER study,” said chief executive Markku Jalkanen.
Clevegen showing ‘early promise’ in clinical trial
Faron’s main focus in recent months has been on Clevegen, its cancer immunotherapy which is currently undergoing a phase I/II study.
Cancer cells are notoriously good at evading detection by the immune system, but Clevegen has been designed to recognise the tumour cells and break their protective shell.
Investigators have been encouraged by the “promising early observations”, and the plan is to start enrolling more patients with late-stage colorectal cancer.
‘Pivotal year ahead’
“We were also pleased to start dosing the first patients with Clevegen in the MATINS trial, on schedule, and I am greatly encouraged by the promising early observations and data we have seen,” said CEO Jalkanen.
“I remain very optimistic about the future of Clevegen and the potential clinical benefit it may provide to late stage cancer patients.”
He added: “I believe 2019 will be a pivotal year for Faron during which we will continue to expedite Clevegen's development through clinical trials; seek approval from the FDA and the EMA on the CALIBER trial design for Traumakine whilst also advancing partnering discussions for both product candidates.”
Money in the bank
From a financial standpoint, Faron recorded a loss of €20.1mln last year (2017: loss of €21.1mln).
The company ended the period with €4.1mln (2017: €9.3mln), although this number was boosted by a €15.0mln fundraise in February and a €2.9mln placing a month later.
That cash has been set aside to support preparations for the commercialisation of Traumakine and to advance the clinical development of Clevegen in several indications.
Faron shares dropped 7.5% to 65.3p on Tuesday.
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