Faron Pharmaceuticals: Phase II INFORAAA study update

Interim analysis supports continuation of study 

TURKU - FINLAND, 26 June 2019 - Faron Pharmaceuticals Oy (AIM: FARN), the clinical stage biopharmaceutical company, today announces interim results from the Phase II INFORAAA study, which examined the effect of Traumakine on mortality (predominantly for Multi-Organ Failure, MOF) and pharmacodynamic biomarkers of surgically operated Ruptured Abdominal Aorta Aneurysm (RAAA) patients.

Traumakine treatment during the INFORAAA trial was identical to the INTEREST trial with treatment once a day for six days following surgical operation. The ratio of the treatment arm versus placebo was two to one and mortality was assessed for a period of 30 days after surgery. RAAA patients suffer two cycles of a potential ischemic injury to the vascular endothelium: the first caused by the rupture of the aorta and the resulting hemodynamic and circulatory collapse, which is then followed by the cross-clamping and un-clamping of the aorta leading to reperfusion injury. These mechanisms contribute to hypoxia-induced inflammation and multi organ failure, which is the main cause of death within the first 5-10 days. The expected mortality is normally between 30-50% of all operated patients.

A total of 35 patients were included in the interim read out, 25 of which were treated with Traumakine and 10 of which received placebo. Biomarker (MxA and CD73) responses indicated a good interferon response. Unexpectedly, concomitant corticosterone was recorded both in the active (28%) and placebo (30%) treatment arm. Measurement of CD73 serum concentrations indicated that this concomitant corticosteroid use abolished a CD73 response, as observed earlier in all three previous studies (two independent phase III and the YODA study). Patients without Traumakine-induced CD73 values were more likely to die than those with induction. Unfortunately, while the removal of corticosteroid-treated patients from statistical analysis reduced group sizes and made statistical mortality analysis meaningless, a trend toward reduction of mortality was seen in the Traumakine-treated patients who did not receive corticosteroids. Mortality in various groups varied from 15-20%, except in those patients without induced CD73 concentrations - mortality in that group was high with 6 out of 7 (85.7%) not surviving.

Based on the study's predefined decision criteria and statistical analysis of mortality in the active and placebo treatment arms the study may proceed. The Company will evaluate these data, together with previously announced data from the YODA trial and post-hoc INTEREST data to finalise its plans for future Traumakine development and will make further announcements in due course.

Dr Markku Jalkanen, Chief Executive Officer of Faron, said: "The INFORAAA interim data is very important to us as it again shows the protective effects of CD73 activation without the presence of steroids. It is still too early to estimate the efficacy of Traumakine in this setting because of the limited number of evaluable patients without concomitant steroids, however the interim analysis supports the continuation of the study according to current powering. It was disappointing to learn about this magnitude of steroid use in this patient population as RAAA is considered as a traumatic condition and to have only limited inflammatory impact on disease development." 

This announcement contains inside information for the purposes of Article 7 of Regulation (EU) No 596/2014 ("MAR").

For more information please contact:

Faron Pharmaceuticals Oy

Dr Markku Jalkanen, Chief Executive Officer

investor.relations@faron.com

Panmure Gordon (UK) Limited, Nomad and Broker

Emma Earl, Freddy Crossley (Corporate Finance)

James Stearns (Corporate Broking)

Phone: +44 207 886 2500

Consilium Strategic Communications

Mary-Jane Elliott, David Daley, Lindsey Neville

Phone: +44 (0)20 3709 5700

E-mail: faron@consilium-comms.com

Westwicke Partners, IR (US)

Chris Brinzey

Phone: 01 339 970 2843

E-Mail: chris.brinzey@westwicke.com

About Ruptured Abdominal Aortic Aneurysm (RAAA)

Ruptured Abdominal Aortic Aneurysm (RAAA) is a surgical emergency with an overall mortality of 70 to 80%. It requires immediate surgery and aortic repair. Approximately half of the deaths of RAAA patients is due to not reaching the hospital in time, and despite immediate surgery and intensive care treatment, the second half dies in hospital within 30 days post-operatively, mostly due to multi-organ failure. The cause of high post-operative mortality is mainly due to prolonged hypotension/hypoxia from the ruptured aorta and the aftermath of restoring blood flow: reperfusion, vascular leakage and failure of vital organs. Currently there are an estimated 40,000 US and European patients per annum eligible for the treatment, making this an orphan indication.

About Faron Pharmaceuticals Ltd

Faron (AIM:FARN) is a clinical stage biopharmaceutical company developing novel treatments for medical conditions with significant unmet needs. The Company currently has a pipeline focusing on acute organ traumas, vascular damage and cancer immunotherapy. The Company's first candidate Traumakine, to prevent vascular leakage and organ failures, has completed a Phase III clinical trial in Acute Respiratory Distress Syndrome (ARDS). An additional European Phase II Traumakine trial is underway for the Rupture of Abdominal Aorta Aneurysm ("RAAA"). Faron's second candidate Clevegen is a ground breaking early clinical anti-Clever-1 antibody. Clevegen has the ability to switch immune suppression to immune activation in various conditions, with potential across oncology, infectious disease and vaccine development. This novel macrophage-directed immuno-oncology switch called Turn-on-your-Immunity or Turn-It may be used alone or in combination with other immune checkpoint molecules for the treatment of cancer patients. Faron is based in Turku, Finland. Further information is available at www.faron.com

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