Results from the Japanese Phase III study

RNS Number : 3231X

Faron Pharmaceuticals Oy

29 April 2019

 

Faron Pharmaceuticals Ltd

("Faron" or the "Company")

Results from the Japanese Phase III study with Traumakine in the treatment of ARDS

TURKU - FINLAND, 29 April 2019 - Faron Pharmaceuticals Ltd ("Faron") (AIM: FARN), the clinical stage biopharmaceutical company, today announces that its Japanese licensing partner Maruishi Pharmaceutical Co., Ltd. ("Maruishi") has provided clinical trial results on its Phase III Japanese Traumakine^® study for the treatment of acute respiratory distress syndrome ("ARDS").

The results of the trial are in line with Faron's expectations which were detailed in the Proposed Placing announcement on 26 March 2019. In particular:

• Treatment with Traumakine did not result in reduced mortality or increased number of ventilator free survival days when compared to placebo.
• Overall, the placebo and Traumakine treatment groups were well balanced in basic demographics, except that the Traumakine group had more sepsis and less pneumonia as the etiology of ARDS when compared to the placebo group.

According to the post-hoc analysis, the overall percentage of study subjects who received concomitant glucocorticoids was 77%, which was higher than that of the INTEREST study. The effect of glucocorticoids showed similar trends to that observed from the INTEREST study. Due to the limited trial size, further sub-group analysis is not meaningful.

Dr Markku Jalkanen, CEO of Faron, said: "As we had already observed in the INTEREST trial,  it appears likely that corticosteroid use  diminished the treatment benefit of Traumakine in ARDS patients in the Japanese Phase III study. Unfortunately, the use of steroids has become a standard in ARDS despite any evidence base and this requires critical reassessment, as the use of steroids appears to worsen outcomes in certain ARDS subgroups."

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

Dr Markku Jalkanen, Chief Executive Officer

[e-mail] 

Consilium Strategic Communications

Mary-Jane Elliott, David Daley, Lindsey Neville

Phone: [phone]

E-mail: [e-mail]

Westwicke Partners, IR (US)

Chris Brinzey

Phone: [phone]

E-Mail: [e-mail]

Panmure Gordon (UK) Limited, Nomad and Broker

Emma Earl, Freddy Crossley

Phone: [phone] 

¹ JAMA. 2016 Feb;315(8):788-800

² Intensive Care Med. 2011;37(12):1932

³ N Engl J Med. 2005;353(16):1685

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

About Maruishi Pharmaceutical Co., Ltd.

Maruishi, an Osaka-based, R&D-orientated company with over 130-year history, has a strong presence in the Japanese market as a specialty pharma developing, manufacturing, and marketing perioperative drugs and drugs used in the acute settings. Maruishi continues to be proactively engaged in R&D activities to contribute to the improvement of the quality of life (QOL) of patients.

 

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