(Recruitment completed in Traumakine INTEREST Trial)
On 11 December 2017, Faron Pharmaceuticals Ltd released a news on its website as follows:
Recruitment completed in Traumakine INTEREST Trial
The upcoming read-out will collate intact 90 day morbidity/mortality data alongside 28 day mortality data as requested by the study IDMC
Phase III INTEREST top line results expected in H1 2018
TURKU – FINLAND, 11 December 2017 – Faron Pharmaceuticals Ltd (“Faron”) (AIM: FARN), the clinical stage biopharmaceutical company, announces that it has completed recruitment, on track, for its Phase III INTEREST trial of Traumakine® for the treatment of moderate to severe Acute Respiratory Distress Syndrome (ARDS).
In addition to the completion of recruitment, the Company reports that it has adopted recommendations from the INTEREST trial’s Independent Data Monitoring Committee (IDMC) and Steering Committee (SC) to present patient data showing blinded ARDS outcomes (mortality/morbidity) at 90 days (D90), in addition to the day 28 (D28) mortality endpoint. Outcomes at D90 are widely recognised to be as important clinically when judging the benefit of treatment alongside the D28 data. This recommendation was made following the FDA’s recent proposal for Faron to proceed directly to BLA filing for Traumakine in the US using data obtained from the European and Japanese trials. The Company expects therefore that the INTEREST top-line data from the trial will become available in H1 2018 following collation of the D90 data. Faron’s Japanese partner Maruishi also expects Japanese phase III results in 2018.
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, which has successfully recruited its target of 300 patients, is currently being conducted in more than 60 hospital intensive care units (ICU) in Belgium, Finland, France, Germany, Italy, Spain, UK and Czech Republic. The key efficacy endpoint in the INTEREST trial is the all-cause mortality rate at day 28. The INTEREST trial protocol is targeting a 50% reduction in all cause mortality at day 28 between placebo and treatment arm (from 30% down to 15%).
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 plus annual cases in Europe and US alone.
Dr Markku Jalkanen, CEO of Faron, said: “We are extremely pleased to have completed recruitment for the INTEREST study within our expected timelines and are grateful for all parties involved in reaching this milestone. Closing the recruitment marks another important step for Traumakine and Faron. Our focus is now on closing the data basis for read-out purposes and bringing this product to the market as expediously as possible in order to provide patients with this life threathening condition a treatment option where currently there is none.”
Professor Geoff Bellingan from the University College London Hospital and the Co-principal Investigator of the INTEREST trial, added: “All of us who have been involved with this study have shared the excitement of the INTEREST trial as it offers the potential to finally have an effective pharmacological treatment for ARDS patients. We fully support the advice from the IDMC and SC to hold reporting results until we have both D28 and D90 data as this offers the ideal non-biased means of protecting the data integrity for regulatory purposes. We are aware that the FDA, in particular, has appreciated the inclusion of D90 survival data alongside the D28 endpoints. Given the need for this treatment for our patients, we now look forward to completing the data verification and presenting top line results in the first half of 2018.”
For more information please visit: http://otp.investis.com/clients/uk/faron/rns/regulatory-story.aspx?newsid=956905&cid=2223