Faron Pharma Regulatory News (FARN)

Faron Pharmaceuticals Ltd

("Faron" or the "Company")

Study update: Traumakine® Phase II/III INFORAAA trial for Multi-Organ Failure receives recommendation from IDMC

First recommendation received from the IDMC to continue study as planned

TURKU - FINLAND, 19 December 2017 - Faron Pharmaceuticals Ltd ("Faron") (AIM: FARN), the clinical stage biopharmaceutical company, announces that it has received the first recommendation from the Independent Data Monitoring Committee (IDMC) of the INFORAAA study to continue the trial as planned using Faron's wholly owned lead product, Traumakine®. The study currently has six open sites in Finland, two in Lithuania and one in Estonia. The first sites in the UK will open in the beginning of 2018. The INFORAAA study aims to treat a total of 160 post-operative Ruptured Abdominal Aorta Aneurysm (RAAA) patients and the interim results are expected in H2 2018.

The Phase II/III INFORAAA clinical trial of Traumakine for the treatment of Multi-Organ Failure (MOF) and mortality prevention in surgically operated RAAA patients is based on a similar treatment regimen to the regimen used in patients in the Company's recently completed Phase III INTEREST trial for Acute Respiratory Distress Syndrome (ARDS). 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, the principal cause leading to the death of RAAA patients, who demonstrate a 30-50% mortality rate post-operatively. RAAA accounts for 13-14/100,000 hospital admissions annually (Anjum et al., 2012), and is Faron's second indication for Traumakine in clinical evaluation.

Patients with RAAA frequently experience Systemic Inflammatory Response Syndrome (SIRS), despite successful open surgical repair, which can especially affect 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). The Directors of Faron consider that data seen to date support the rationale for extending the use of Traumakine in similar conditions to potentially treat single, and multiple, organ failures. Data demonstrated during the Traumakine Phase I/II study showed a reduced need for haemodialysis (an indication of improved kidney function) among the ARDS patients dosed with Traumakine.

Separately, in Faron's Phase III INTEREST trial of Traumakine, the Company recently completed recruiting patients being studied for the treatment of moderate to severe ARDS. Top-line data from the INTEREST trial is due in H1 2018. In September 2017 Faron received advice from US FDA to proceed directly to BLA submission following completion of EU and Japanese Phase III studies. In October 2017, Faron received notification from the United Kingdom's Medicines and Healthcare Products Regulatory Agency (MHRA) that Traumakine was granted Promising Innovative Medicines (PIM) designation. There is currently no approved pharmaceutical treatment for ARDS.

Dr Markku Jalkanen, CEO of Faron, said: "This is another piece of good news for Faron during a highly successful year and we are now focused on demonstrating that our wholly-owned lead product, Traumakine, has applicability in RAAA patients as well as in the ARDS indication. RAAA patients go through a serious surgical procedure which currently often results in major organ failure. This study is designed to demonstrate that major organs including the kidney, liver and GI-tract could recover if patients are dosed with Traumakine. 2018 is well set to be a pivotal year for Faron given our Phase III INTEREST read out in H1 and we look forward to the coming months with great confidence."

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 are 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.

For more information please contact:

Faron Pharmaceuticals Ltd

Dr Markku Jalkanen, Chief Executive Officer

investor.relations@faron.com 

Consilium Strategic Communications

Mary-Jane Elliott, Chris Welsh, Philippa Gardner, 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

Panmure Gordon (UK) Limited, Nomad and Broker

Freddy Crossley (Corporate Finance)

Tom Salvesen (Corporate Broking)

Phone: +44 207 886 2500

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 lead candidate Traumakine, to prevent vascular leakage and organ failures, is currently the only treatment for Acute Respiratory Distress Syndrome (ARDS) undergoing Phase III clinical trials and in 2017 received advice from US FDA to proceed directly to BLA submission following completion of EU and Japanese Phase III studies. There is currently no approved pharmaceutical treatment for 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 pre-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 Tumour Immunity Enabling Technology ("TIET") 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