Faron Pharma Regulatory News (FARN)

Faron Pharmaceuticals Oy

("Faron" or the "Company")

First Patient Recruited in Phase II RAAA Study

First patient recruited in the Traumakine® INFORAAA trial for the prevention of Multi-Organ Failure and patient mortality after surgical repair of a Ruptured Abdominal Aortic Aneurysm (RAAA)

TURKU - FINLAND, 20 February 2017 - Faron Pharmaceuticals Ltd ("Faron") (LON: FARN), the clinical stage biopharmaceutical company, is pleased to announce the enrolment of the first patient in the Phase II INFORAAA clinical trial of Traumakine® for the treatment of Multi-Organ Failure (MOF) and mortality prevention of surgically operated Ruptured Abdominal Aorta Aneurysm (RAAA) patients. The high mortality rate of RAAA, which accounts for 4-5 deaths per 100,000 population (Karthikesalingam et al., 2014), requires new treatments to prevent post-operative reperfusion injury leading to the death of RAAA patients, which exhibits a 30-50% mortality rate post-operatively. RAAA accounts for 13-14/100,000 hospital admissions annually (Anjum et al., 2012), and is the second indication for Traumakine targeted by Faron.

Open surgical aortic repair to treat RAAA patients is associated with a Systemic Inflammatory Response Syndrome (SIRS) affecting vital organs, especially the heart, lungs, kidneys, and intestines. The death of approximately 80% of the operated RAAA patients is caused by MOF, similar to patients with Acute Respiratory Distress Syndrome (ARDS). Traumakine (FP-1201-lyo) is currently in a European Phase III clinical trial for the treatment of ARDS, with encouraging Phase I/II data. The Directors consider that data seen to date supports the rationale for extending the use of Traumakine in similar conditions to potentially treat single, and multiple, organ failures. For example, during the Traumakine phase I/II study, there was a reduced need for haemodialysis (an indication of improved kidney function) among the ARDS patients on Traumakine.

Dr Markku Jalkanen, CEO of Faron, said: "We are delighted to start the trial with the first patient enrolled in the Phase II INFORAAA trial for the reduction of post-operative RAAA patient mortality. The main cause of death for these patients is MOF following a post-operative reperfusion injury of ischemic organs including kidneys, liver, brain and intestines. We believe that Traumakine shows significant efficacy for the recovery of operated RAAA patients. Furthermore, there is a possibility that a positive outcome of both the INFORAAA and INTEREST trials could result in the INFORAAA trial fulfilling Phase III trial requirements. The clinical data of RAAA patients treated with FP-1201-lyo during the INFORAAA trial could also provide us with valuable information on the recovery of ischemic single organ injuries and planning further trials to treat these injuries."

The Phase II INFORAAA trial (EudraCT 014-000899-025) evaluates the efficacy and safety of FP-1201-lyo compared to placebo for the prevention of MOF following open surgery for RAAA. The trial is a double-blind, randomised (2:1), parallel group study and the same dosing is used as in the on-going INTEREST Phase III trial for the treatment of ARDS patients, who also experience MOF. Both FP-1201-lyo and placebo are administered intravenously once a day for six consecutive days post-operation in addition to intensive care. The primary end point of the INFORAAA trial is to evaluate mortality after 30 days of the first dose administration and the trial also has several secondary and explorative end points, which are related to the nature of these patients. The trial is initiated with 8 sites in Finland and is planned to be expanded to Baltic States and UK.

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 20,000 US and European patients per annum eligible for treatment.

Cited references:

Karthikesalingam A, Holt PJ, Vidal-Diez A, Ozdemir BA, PoloNiecki JD, Hinchliffe RJ and Thompson MM (2014) Mortality from ruptured abdominal aortic aneurysms: Clinical lessons from a comparison of outcomes in England and the USA. Lancet 383: 963-69.

Anjum A, Allmen von R, Greenhalgh R and Powell JT (2012) Explaining the decrease in mortality from abdominal aortic aneurysm rupture. British J. Surgery 99: 637-45.

The information contained within this announcement is deemed to constitute inside information as stipulated under the Market Abuse Regulation (EU) No. 596/2014. Upon the publication of this announcement, this inside information is now considered to be in the public domain.

For more information please contact:

Hume Brophy, PR (UK)

Conor Griffin, Alexia Faure, Alex Protsenko

Phone: +44 207 862 6381

E-mail: faron@humebrophy.com 

Consilium Strategic Communications

Mary-Jane Elliott, Chris Welsh, Lindsey Neville

Tel: +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

Cairn Financial Advisers LLP, Nominated Adviser

Emma Earl, Tony Rawlinson, Rebecca Anderson

Phone: +44 207 213 0880

Panmure Gordon (UK) Limited, Joint Broker

Freddy Crossley, Duncan Monteith (Corporate Finance)

Tom Salvesen (Corporate Broking)

Phone: +44 207 886 2500

Whitman Howard Limited, Nominated Broker (UK)

Ranald McGregor-Smith, Francis North

Phone: +44 207 659 1234

About Faron Pharmaceuticals Ltd

Faron 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, cancer immunotherapy and vascular damage. The pipeline is built on Faron's scientific knowledge and control of the endothelial barrier, the membrane of cells lining blood and lymphatic vessels to separate blood content from tissues. The Company's lead candidate Traumakine is in development for the treatment of Acute Respiratory Distress Syndrome ("ARDS"), a rare, severe, life-threatening medical condition characterised by widespread inflammation in the lungs. Traumakine is currently in pan-European (INTEREST) and Japanese pivotal Phase III studies, and is commencing a European Phase II trial for the Rupture of Abdominal Aorta Aneurysm ("RAAA"). Additionally, Faron is developing Clevegen® a ground breaking pre-clinical anti-Clever-1 antibody. Clevegen has the ability to convert the immune environment around a tumour from being immune suppressive to immune stimulating. This novel macrophage-directed immuno-oncology approach is called Tumour Immunity Enabling Technology ("TIET") and can be used alone or in combination with other immune checkpoint molecules for the treatment of cancer patients. New application opportunities related to TIET cover chronic infections and inefficient vaccination. Based in Turku, Finland, Faron Pharmaceuticals is listed on AIM under the ticker 'FARN'. Further information is available at www.faronpharmaceuticals.com