Date: 2017-12-11
Type of
information: Completion of patient enrollment
phase: 3
Announcement: completion of patient enrollment
Company: Faron Pharmaceuticals (Finland)
Product: FP-1201-lyo (the lyophilised form of Traumakine® (human recombinant interferon-beta 1a)
Action
mechanism:
- protein. FP-1201/Traumakine® is a human recombinant interferon-beta 1a. In acute lung injury (ALI) and acute respiratory distress syndrome (ARDS), the predominant patho-physiological result is increased vascular leakage, which has been shown to be due to the lack of adenosine, an end product of AMP degradation by 5’-nucleotidase (CD73). Adenosine acts to enhance endothelial barrier function via adenosine receptor activation. Therefore, any biological substance, which acts to increase adenosine level, will reduce vascular leakage and be of benefit in ALI/ARDS patients. Such substances are type I interferons, and especially the interferon-beta (IFN-beta). IFN-beta has been shown to up-regulate 5’-nucleotidase (also known as a CD73 molecule and expressed abundantly by normal endothelial cells) and prevent ALI in animal models (Kiss et al. (2007) Eur. J. Immunol. 37:3334). 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.
Disease: acute respiratory distress syndrome (ARDS)
Therapeutic
area: Lung diseases - Respiratory diseases - Rare diseases
Country: Belgium, Finland, France, Germany, Italy, Spain, UK
Trial
details:
- This phase III double-blind, randomised, parallel-group study will compare of the efficacy and safety of FP-1201-lyo and placebo in the treatment of patients with moderate or severe acute respiratory distress syndrome. In this study effectiveness and safety of FP-1201-lyo (recombinant human interferon beta-1a) is compared to placebo. Investigation is conducted with patients who have acute respiratory distress syndrome (ARDS). The new drug is expected to reduce the time which a patient need to be on the ventilator and improve patient's chances of survival. (NCT02622724)
Latest
news:
- • On December 11, 2017, Faron Pharmaceuticals 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.
- Faron 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, 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%).
-
• On August 4, 2017, Faron Pharmaceuticals provided an update on the INTEREST Phase III study treating patients with moderate to severe Acute Respiratory Distress Syndrome (ARDS) with Traumakine®, following a meeting of the trial's Independent Data Monitoring Committee (IDMC) on 1 August 2017. At this fifth and advanced meeting, the IDMC has recommended that the trial should continue as planned with no changes, consistent with the previous four IDMC recommendations. Faron anticipates that recruitment of the targeted 300 patients will complete during the fourth quarter of 2017.
- As the INTEREST Phase III study nears completion, Faron plans to initiate an expanded access program for Traumakine to start once the trial is closed to new patients. This will allow compassionate use of Traumakine in eligible named patients at European ICU hospitals, who may benefit from Traumakine treatment ahead of the product's potential regulatory approval.
- • On May 8, 2017, Faron Pharmaceuticals announced 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 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.
- • On December 29, 2015, Faron Pharmaceuticals announced the enrolment of the first patient in the Phase III INTEREST clinical programme for Traumakine® for the treatment of acute respiratory distress syndrome. In the earlier completed phase 1-2 trial in respect of Traumakine® the drug candidate was associated with an 81% reduction in the odds of 28-day mortality. 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.
- 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.
Is
general: Yes
