Only 48 out of 144 patients in the INTEREST Traumakine group showed adequate b-IFN-biomarker response and consequently reduced mortality. If Faron can define which are the characteristics of the responding patients, they may have the information that could have better defined the population for this Phase III INTEREST study. This again underlines that its challenging to move from Phase I/II in a small population to a Phase III study.
Gaea took the trial over from a global big 5 CROs, the first double-blind placebo-controlled phase III trial in acute respiratory distress syndrome (ARDS), a serious condition with a ~30-% mortality by day-28 under the best standard of care. With our knowledge of the issues in the acute and emergency care settings, we defined and set up an eligibility confirmation process. This was complex as diagnostic chest X- rays cannot be emailed from most centres. Our two senior intensive care medical monitors teamed up to be on call 24/7 to check every screened patient, to reduce ineligible patients, and talk through the issue with the enrolling site staff. ARDS is a syndrome, so diagnosis is difficult and borderline screened subjects may represent typical patients but are a major issue for protocols in the acute care setting with the critically ill. This was a first time in an intensive care trial. Gaea worked through the national variations in consent in the seven countries for incapacitated patients. Gaea set up and managed the IDMC.
We ran the trial, through regulatory and opening 65 sites in the seven countries, enrolling 95 percent of the subjects and assessed three more countries.
The trial failed to meet its primary endpoint versus placebo: “Treatment with Traumakine did not result in an increased number of ventilator free survival days or a reduced mortality rate when compared to placebo. The median number of ventilator free days at Day 28 was 10 days in patients treated with Traumakine, compared with 8.5 days. All-cause mortality after 28 days was 26.4% for the Traumakine group, compared with 23% for the placebo group”.
We look forward to using this rare and significant experience in IC to assist any sponsors with trials in the acute and intensive care settings.