Faron Pharmaceuticals Oy
(“Faron” or the “Company”)
Update on INTEREST Phase III Study for Traumakine® in ARDS from IDMC
TURKU – FINLAND, 08 May, 2017 - Faron Pharmaceuticals Ltd (“Faron”) (LON: FARN), the clinical stage biopharmaceutical company, announces that it has received an expected report dated 4th May 2017 from the Independent Data Monitoring Committee (IDMC) on the INTEREST Phase III study for the treatment of patients with moderate to severe Acute Respiratory Distress Syndrome (ARDS) with its lead product Traumakine.
At this fourth meeting the IDMC has recommended to Faron that the trial should continue as planned with no changes, consistent with the recommendation received from IDMC as a result of three previous meetings. The IDMC also informed Faron that they will provide the next advanced recommendation after reviewing the data at 240 recruited patients. The Company expects this to take place during the third quarter of 2017.
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 with around 300,000 annual cases in Europe and US.
The INTEREST trial is a Phase III double-blind, randomised, parallel-group comparison of efficacy and safety of Traumakine (FP-1201-lyo) and placebo in the treatment of patients with moderate to severe ARDS. The study, designed to include up to 300 patients, is currently being conducted in 60 hospital intensive care units (ICU) in Belgium, Finland, France, Germany, Italy, Spain and UK. The primary efficacy endpoint in the INTEREST trial is the all-cause mortality rate at day 28, the only accepted primary end point for marketing approval by EMA. The INTEREST trial protocol is targeting a 50% reduction in all cause mortality at day 28 between placebo and treatment arm (from 30% to 15%).
Dr Markku Jalkanen, Chief Executive Officer of Faron Pharmaceuticals, commented: “We were again very delighted to learn that the IDMC gave us another recommendation to continue the INTEREST study as planned. We are looking forward to their next recommendation in Q3 2017, which we hope to confirm our plans for the future of the product and for ARDS patients.”
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.
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For more information, please contact:
Faron Pharmaceuticals Oy
Dr Markku Jalkanen, Chief Executive Officer
Consilium Strategic Communications
Mary-Jane Elliott, Chris Welsh, Lindsey Neville
Phone: +44 (0)20 3709 5700
Westwicke Partners, IR (US)
Phone: 01 339 970 2843
Cairn Financial Advisers LLP, Nominated Adviser
Emma Earl, Tony Rawlinson
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 (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. 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.faronpharmaceuticals.com
Caution regarding forward looking statements
Certain statements in this announcement, are, or may be deemed to be, forward looking statements. Forward looking statements are identiﬁed by their use of terms and phrases such as ''believe'', ''could'', "should", “expect”, ''envisage'', ''estimate'', ''intend'', ''may'', ''plan'', ''potentially'', ''will'' or the negative of those, variations or comparable expressions, including references to assumptions. These forward looking statements are not based on historical facts but rather on the Directors' current expectations and assumptions regarding the Company's future growth, results of operations, performance, future capital and other expenditures (including the amount, nature and sources of funding thereof), competitive advantages, business prospects and opportunities. Such forward looking statements reﬂect the Directors' current beliefs and assumptions and are based on information currently available to the Directors.
A number of factors could cause actual results to differ materially from the results discussed in the forward looking statements including risks associated with vulnerability to general economic and business conditions, competition, environmental and other regulatory changes, actions by governmental authorities, the availability of capital markets, reliance on key personnel, uninsured and underinsured losses and other factors, many of which are beyond the control of the Company. Although any forward looking statements contained in this announcement are based upon what the Directors believe to be reasonable assumptions, the Company cannot assure investors that actual results will be consistent with such forward looking statements. Accordingly, readers are cautioned not to place undue reliance on forward looking statements. Subject to any continuing obligations under applicable law or any relevant AIM Rule requirements, in providing this information the Company does not undertake any obligation to publicly update or revise any of the forward looking statements or to advise of any change in events, conditions or circumstances on which any such statement is based.
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