Faron Pharmaceuticals Ltd
("Faron" or the "Company")
TURKU - FINLAND, 8 May 2018 - Faron Pharmaceuticals Ltd ("Faron") (AIM: FARN), the clinical stage biopharmaceutical company, today announces top line data from its pan-European Phase III INTEREST trial. The INTEREST study did not meet the Day 28 (D28) primary efficacy composite endpoint of ventilator free days and survival with Traumakine treatment.
Treatment with Traumakine did not result in an increased number of ventilator free survival days or a reduced mortality rate when compared to placebo.
Safety was continually monitored throughout the study and there were no clinical concerns following the repeated administration of Traumakine.
Dr Markku Jalkanen, CEO of Faron, said: "We are incredibly disappointed and surprised by these results. We need to further analyse the data in order to understand how this study differs from our previous positive results with ARDS patients, both in terms of Traumakine's efficacy, and in the unusually low mortality rate observed in the placebo arm. We look forward to the results of the Japanese study in Q3 2018 and will be considering how we can advance Traumakine in clinical development.
"We will continue our plans to advance our next asset, Clevegen, our second candidate which is a ground breaking anti-Clever-1 antibody, into clinical development in solid cancers later this year.
"I would like to thank everyone who has been involved in the study including our investigators, study personnel, the team at Faron and, most of all, the patients and their families who participated in the study."
The INTEREST trial was a Phase III double-blind, randomised, parallel-group comparison to assess the efficacy and safety of Traumakine® (FP-1201-lyo) versus placebo in the treatment of patients with moderate to severe Acute Respiratory Distress Syndrome (ARDS). The study, which recruited 300 patients, was conducted in 64 hospital intensive care units (ICU) in Belgium, the Czech Republic, Finland, France, Germany, Italy, Spain and the UK.
ARDS is a severe orphan disease with a reported mortality rate of approximately 30-45%,,, for which there is currently no approved pharmacological treatment. It is characterised by widespread capillary leakage and inflammation in the lungs, most often as a result of pneumonia (e.g. following a pandemic influenza), sepsis, or significant trauma. Faron estimates there are around 300,000 plus annual cases in Europe and US alone.
This announcement contains inside information for the purposes of Article 7 of Regulation (EU) No 596/2014 ("MAR").
Faron Pharmaceuticals Ltd
Dr Markku Jalkanen, Chief Executive Officer
Consilium Strategic Communications
Mary-Jane Elliott, Philippa Gardner, Matthew Neal, Lindsey Neville
Phone: +44 (0)20 3709 5700
Westwicke Partners, IR (US)
Phone: 01 339 970 2843
Panmure Gordon (UK) Limited, Nomad and Broker
Freddy Crossley, Emma Earl, Ryan McCarthy
Phone: +44 207 886 2500
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, 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 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