Faron Pharmaceuticals Oy
(“Faron” or the “Company”)
TURKU – FINLAND, 29 December 2015 – Faron Pharmaceuticals Ltd (”Faron”) (LON: FARN), the clinical stage biopharmaceutical company, is pleased to announce the enrolment of the first patient in the Phase III INTEREST clinical programme for Traumakine® for the treatment of acute respiratory distress syndrome (“ARDS”).
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 sepsis, pneumonia or significant trauma. In the earlier completed Phase I/II trial in respect of Traumakine® the drug candidate was associated with an 81% reduction in the odds of 28-day mortality. Traumakine® has been granted Orphan Drug Designation in Europe which allows a period of 10 years of market exclusivity following marketing approval by the EMA.
The recruitment of the first patient, so soon after the Company’s recent IPO, is consistent with the anticipated timeline of 12 to 18 months required to complete recruitment for the pivotal Phase III trial for Traumakine®. The Phase III trial is being led by Professor Geoff Bellingan from University College London Hospital and Professor Marco Ranieri from the University of Rome.
Dr Markku Jalkanen, CEO of Faron said: ”Following our successful IPO, we very much welcome the commencement of patient recruitment for the pivotal Phase III trial for this awful condition, ARDS which has significant unmet medical needs. Our previous exceptional results with an 81% reduction in odds of 28-day mortality of ARDS patients have excited our clinical network, which we expect will facilitate completion of patient recruitment within the anticipated time frame of 12-18 months. We believe that Traumakine® presents a significant opportunity for those suffering from ARDS, the hospitals which treat them and the societies covering the recovery of ARDS patients.”
The Phase III clinical trial INTEREST is a double-blinded, randomised, parallel-group comparison of efficacy and safety of FP-1201-lyo (the lyophilised form of Traumakine®) and placebo in the treatment of patients with moderate to severe ARDS. The INTEREST trial will be conducted through 55 hospitals in Belgium, Finland, France, Germany, Italy, Spain and UK with the target of recruiting 300 ARDS patients in total.
In addition to the orphan drug designation of Traumakine® in Europe, the Company has applied for the same orphan status in the U.S. and will update Shareholders in due course when the outcome of the Company’s application is known.
For more information contact:
Faron Pharmaceuticals Oy
Phone +358 (50) 577 4807
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Emma Earl, Tony Rawlinson and Rebecca Anderson
Phone: +44 207 148 7900
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Niall Devins, Francis North
Phone: +44 207 659 1234
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Mary Clark, Eva Haas, Hollie Vile
Phone: +44 203 440 5654
Faron is a drug discovery and development company focused on creating novel treatments for medical conditions with significant unmet needs. The Company is based in Turku, Finland. The Company currently has a pipeline of products focusing on acute organ traumas, cancer immunotherapy and vascular damage. The Company’s lead candidate Traumakine®, has been developed to treat acute respiratory distress syndrome (“ARDS”), a rare, severe, life threatening medical condition for which there is currently no approved pharmaceutical treatment. Traumakine® is now in a pan-European pivotal Phase III study (INTEREST). Besides Traumakine®, Faron's pipeline consists of early stage assets including a pre-clinical anti-Clever-1 antibody named Clevegen. Clevegen is focused on converting the immune environment around a tumour from being immune suppressive to immune stimulating. Further information is available at www.faronpharmaceuticals.com.
ARDS is a severe, life-threatening medical condition characterised by widespread inflammation in the lungs and sudden failure of the respiratory system. ARDS causes inflammation of the alveoli in the lungs, which are unable to perform the normal oxygenation of blood. It is characterised by rapid breathing, difficulty getting enough air into the lungs and low blood oxygen levels. Common causes of ARDS are sepsis, pneumonia, aspiration of fumes, food or stomach contents going into the lung or significant trauma. The condition was first described in 1967 and gained wide attention during the Vietnam War when it was nicknamed “white lung” as X-rays presented the lungs of the patients as white.
ARDS is the leading cause of respiratory failure in intensive care unit patients requiring mechanical ventilation and oxygen therapy. Despite progress in critical care medicine ARDS is currently associated with a mortality rate of 30% to 45% depending on the severity of the condition. Although ARDS mortality has decreased in the last decade due to improvements in supportive care and in the treatment of the underlying conditions, it still remains high.
Currently, patients suffering from ARDS are generally treated with lung-protective mechanical ventilation. This treatment is accompanied by ancillary support such as positioning, fluid management, and food restrictions. Extra corporeal support may also be provided depending on the severity of the condition. Complications, which can also arise whilst a patient is being treated for ARDS, include the development of infections, pneumothorax, lung scarring and blood clots, which can develop into a pulmonary embolism. Patients who recover from ARDS may suffer other consequences of ARDS after being discharged from the intensive care unit. A recovering patient’s quality of life may be adversely affected by permanent damage to the lungs, respiratory problems, scar tissue, muscle weakness and depression, all of which can have an adverse effect on the patient’s quality of life.
Faron completed a Phase I/II trial in respect of Traumakine® in 2011 where treatment with Traumakine® was associated with an 81 % reduction in the odds of 28 day mortality in patients with ARDS. These data were published in The Lancet Respiratory Medicine, a leading medical journal (Bellingan et al. 2014) 1.
The scientific rationale for Traumakine treatment is based on the proprietary use of room temperature stable formulation of interferon-beta-1a (FP-1201-lyo) for the restoration of the endothelial barrier function in ARDS patients. In Phase I/II trials interferon-beta was found to be safe and well tolerated in ARDS patients and the optimal tolerated dose was established. The selected pharmacodynamic marker for interferon-beta bioactivity showed clear dose response and the treatment target molecule CD73 levels were induced during the dosing period.
The Traumakine® research consortium (www.traumakine.eu) led by Faron has received €6 million funding from the European Union Seventh Framework Programme (FP7) targeting European marketing application as a final milestone of the programme.
1. Bellingan, G., Maksimow, M., Howell D.C., Stoltz, M., Beale, R., Beatty, M., Walsh, T., Binning, A., Davidson, A., Kuper, M., Shah, S., Cooper, J., Waris, M., Yegutkin, G.G., Jalkanen, J., Salmi, M., Piippo, I., Jalkanen, M., Montgomery, H., Jalkanen, S.: “The effect of intravenous interferon-beta-1a (FP-1201) on lung CD73 expression and on acute respiratory distress syndrome mortality: an open-label study”. Lancet Respiratory Medicine 2014.