First patient recruited in Japanese Ph III trial

RNS Number : 2342N

Faron Pharmaceuticals Oy

24 October 2016

 

Faron Pharmaceuticals Oy

("Faron" or the "Company")

First Traumakine® Phase III patient in Japan recruited for the treatment of acute respiratory distress syndrome

and

Update on Pan-European Phase III Traumakine trial

TURKU - FINLAND, 24 October 2016 - Faron Pharmaceuticals Ltd ("Faron") (LON: FARN), the clinical stage biopharmaceutical company, is pleased to announce that its Japanese licensing partner Maruishi Pharmaceutical Co., Ltd. ("Maruishi") has recruited the first patient in the Japanese Phase III pivotal clinical trial for the treatment of acute respiratory distress syndrome ("ARDS") with FP-1201-lyo (also known as Traumakine®).

Faron has also recently received the second IDMC (Independent Data Monitoring Committee) recommendation to continue the INTEREST pan-European Phase III trial with Traumakine without any modifications.

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. An earlier Phase I/II trial conducted in the UK and published in The Lancet Respiratory Medicine, (Bellingan et al. 2014: 2: 98-107), showed a decline in the odds of all-cause mortality at day 28 of 81%. A Japanese Phase II trial was completed with comparable mortality results and no observed severe adverse events as announced in January 2016.

The Japanese Phase III clinical trial (JapicCTI-163320) is a double-blinded, randomised, parallel-group comparison of efficacy and safety of FP-1201-lyo against placebo in the treatment of maximum 120 patients with moderate to severe ARDS. The initiation of the Japanese study means that the Pan-European and Japanese Phase III trials combined aim to treat maximum 420 moderate to severe ARDS patients with results expected to become available in 2017-2018.

Dr Markku Jalkanen, CEO of Faron said: "We are delighted that patient recruitment for the Japanese Phase III trial has commenced as this trial will significantly increase the total number of patients in Traumakine pivotal studies. It was also encouraging to receive the second IDMC recommendation for the INTEREST pan-European Phase III trial continuation demonstrating the studies are progressing in line with protocol expectations and design."

The information contained within this announcement constitutes inside information stipulated under the Market Abuse Regulation (EU) No. 596/2014.

For more information please contact:

Faron Pharmaceuticals Ltd

Katja Wallenlind

Phone [phone]
E-mail: [e-mail]

Hume Brophy, PR

Mary Clark, Eva Haas, Hollie Vile

Phone: [phone]

E-mail: [e-mail]

Cairn Financial Advisers LLP, Nominated Adviser

Emma Earl, Tony Rawlinson, Rebecca Anderson

Phone: [phone]

Panmure Gordon (UK) Limited, Joint Broker

Freddy Crossley, Duncan Monteith (Corporate Finance)

Tom Salvesen (Corporate Broking)

Phone: [phone]

Whitman Howard Limited, Nominated Broker

Ranald McGregor-Smith, Francis North

Phone: [phone]

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. 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

 

END

 

 

RESLFFEIITLVFIR