Positive Results for Phase 2 Study of EB05 in Critically Ill COVID-19 Patients
On September 20, 2021, Edesa Biotech, Inc. (NASDAQ:EDSA) announced positive results from the Phase 2 portion of the ongoing Phase 2/3 clinical trial of EB05 in critically ill COVID-19 patients. A total of approximately 360 patients, age 24-93, were included in the reviewed data set from clinical trial sites in the U.S., Canada, and Columbia. Patients received a single intravenous infusion of EB05 or placebo in addition to standard of care (dexamethasone and IL-6 inhibitors).
The independent Data and Safety Monitoring Board (DSMB) identified an important treatment effect during the initial analysis of the Phase 2 portion of the study regarding 28-day mortality and requested that the study be preemptively unblinded. The Phase 2 portion of the study was originally designed to guide the patient stratification and statistical powering for the Phase 3 trial, however the DSMB noted that “a clinically important efficacy signal” was detected along with the fact that the study “met its objective”. In addition, the DSMB recommended that the study continue into a Phase 3 confirmatory trial.
In regards to the 28-day mortality data, patients treated with EB05 along with standard of care had a death rate of 14.3% (2/14) compared to 36.8% (7/19) for patients in the placebo plus standard of care arm. These were all critically ill patients on ECMO (extracorporeal membrane oxygenation) therapy. EB05 plus standard of care resulted in a 68.5% reduction in the risk of dying when compared to placebo plus standard of care at 28 days (HR: 3.17 placebo vs. EB05; 95% CI: 0.66-15.35; P=0.15) when using the Cox’s Proportional Hazard Model. In addition, the DSMB identified another patient group with robust signals for mortality reduction at 28 days and the company will be reviewing that data as well as the full data set.
The adverse event profile for EB05 shows that it was generally well tolerated and consistent with the observed safety profile to date.
Based on the Phase 2 results, Edesa will be focusing the Phase 3 trial on patient populations that showed the strongest efficacy signals and have the highest probability of rapidly completing enrollment. Amendments will be filed with regulators in the U.S., Canada, and Columbia to update the Phase 3 protocol with the targeted enrollment. In addition, the company will approach regulators in the U.S. and Canada about the potential for expedited regulatory review.
The data from the Phase 2 trial of EB05 in critically ill COVID patients is really exciting, as there have been few if any breakthroughs in treatments for this patient population. It is particularly encouraging that a signal was seen in a trial that was merely designed to determine the optimal patient population to treat in the Phase 3 study. We are eager to hear about the final Phase 3 trial protocol as well as timelines for when the data from that trial may be available. In addition, we look forward to the company’s analysis of the full Phase 2 data set, which should include details on the other 28-day mortality reduction signal seen by the DSMB. Based on the Phase 2 results we have increased our probability of success for EB05 to 60%, which has increased our valuation from $16 to $20 per share.
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