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Faron Pharmaceuticals Ends Traumakine Trial; Loss Narrows On Expenses

Mon, 23rd Sep 2019 11:37

(Alliance News) - Faron Pharmaceuticals Oy on Monday said its loss narrowed considerably in the first half of 2019, after it cut back on research & development spending and opted to end a clinical trial.

The firm has been developing two drugs: Clevegen, which is intended to treat cancer, and Traumakine, to treat acute respiratory distress syndrome.

While interim results from its phase 2 Inforaaa study, assessing Traumakine's effect on mortality for patients with surgically operated Ruptured Abdominal Aorta Aneurysm, showed a good response, the company has decided to close the trial due to "unexpected high use of concomitant corticosteroids" preventing implementation of the study protocol. Further studies are expected to be funded via a third party.

The biopharmaceutical company posted a pretax loss of EUR6.4 million for the six months ended June 30, less than half its EUR14.1 million loss the year before.

This was due to the drop in research and development expense to EUR5.0 million from EUR11.7 million. Also contributing to this was a reduction in general and administrative expenses to EUR1.4 million from EUR2.4 million.

Revenue was not significant in either year, nothing for the first half of 2019 and only EUR20,000 for the first half of 2018.

In late August, after the end of the first half, Faron raised around EUR2.5 million through an equity issue priced at EUR1.19 per share. This means the company is funded through into the first quarter of 2020.

Faron Chief Executive Markku Jalkanen said: "We have focused on two important matters during H1-2019, Matins study progress and the re-design of Traumakine's development pathway. I am delighted to report that both of these have advanced significantly. Our novel precision cancer immunotherapy, Clevegen, has been well tolerated in cancer patients with advanced solid tumours, all showing an immune switch that we predicted based on the preclinical data and expected mode of action of Clevegen.

"We have also observed a first partial responder showing a constant decline of tumour burden in tumour imaging and biochemical markers. The response in this patient, who suffers from colorectal cancer (MSI low type) and has failed on all previous treatments, is a promising indicator of Clevegen's potential."

However, Jalkanen added: "It has become clear that Traumakine's development requires a study design which would avoid concomitant corticosteroid use. Faron's solution is a design which would allow corticosteroid use within the standard of care arm but never in combination with Traumakine. As soon as the company receives feedback for this new design, we will finalise plans to allow us to progress third party funding discussions. The unmet medical need among these patients is significant and the widespread use of corticosteroids for ARDS and multi-organ failures requires serious re-consideration.

"I am pleased that, through the recent fundraise, the company is in a more secure financial position while we explore partnering activities for Clevegen and funding opportunities for Traumakine."

Shares in Faron were down 1.0% at 104.40 pence in London on Monday.

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