Edesa Biotech (EDSA) cleared by FDA to add sub-study to its ongoing Phase 2/Phase 3 clinical study of its investigational drug, EB05, for ARDS
- Tech stocks push S&P 500 to record close, buoy Nasdaq
- U.S. Calls for Pause of J&J (JNJ) Vaccine After Clotting Cases, Including One Death
- Coinbase (COIN) direct listing IPO reference price set at $250
- Biggest SPAC Deal Ever: Grab To Go Public in a $40 Billion Merger With Altimeter (AGC), Backed by Fidelity and BlackRock
- Oil rises after robust China data but J&J vaccine pause weighs
Get instant alerts when news breaks on your stocks. Claim your 1-week free trial to StreetInsider Premium here.
Edesa Biotech, Inc. (NASDAQ: EDSA), a clinical-stage biopharmaceutical company, has received regulatory approval from the U.S. Food and Drug Administration (FDA) and Health Canada to add a sub-study to its ongoing Phase 2/Phase 3 clinical study of its investigational drug, EB05, for the treatment of Acute Respiratory Distress Syndrome (ARDS) - the leading cause of death in COVID-19 patients. The sub-study will evaluate the drug as a potential rescue therapy for critically severe COVID-19 cases.
Dr. Par Nijhawan, Chief Executive Officer of Edesa, said that physicians involved in the company's ARDS study identified a number of COVID-19 patients who they believed could benefit from the experimental treatment, but were too ill to be considered for the main study. "This sub-study will allow us to potentially expand the use of EB05 to critically ill patients suffering from profound, medically refractory COVID-19 respiratory failure," Dr. Nijhawan said.
Edesa's sub-study is expected to enroll up to 100 ICU patients with severe COVID-19 symptoms, including patients who have been ventilated for more than five days or are receiving extracorporeal membrane oxygenation (ECMO) therapy. The sub-study does not impact the design or results of Edesa's ongoing international Phase 2/3 study.
EB05 is an experimental monoclonal antibody that Edesa believes could regulate the overactive immune response associated with ARDS. Specifically, the drug inhibits toll-like receptor 4 (TLR4) signaling - an important mediator of inflammation responsible for acute lung injury that has been shown to be activated by SARS-CoV2, SARS-CoV1 and Influenza viruses. The goal of the experimental treatment is to suppress inflammation, fluid accumulation and lung injury, thereby reducing the number of patients admitted to Intensive Care Units (ICU) and intubation/ventilation procedures, and ultimately saving lives.
Edesa's Phase 2/3 study is an adaptive, multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of EB05 in adult hospitalized COVID-19 patients. Up to 316 patients will be enrolled in the Phase 2 part of the trial in Canada, the United States and Colombia. Patients will be infused intravenously with a single dose of EB05 or placebo. Should the antibody treatment demonstrate promising results at the Phase 2 readout, the company plans to continue with a pivotal Phase 3 study.
Edesa's Vice President of Research and Development, Blair Gordon, PhD. said that data from the international sites will be aggregated and analyzed together. The sub-study, which is identical to the main study except for the patient enrollment criteria, will be analyzed separately. "The consistency of the study design across geographic regions and patient groups will allow us to efficiently evaluate the utility of the EB05 across a broad spectrum of hospitalized patients."
Hospitals and physicians interested in participating in the Phase 2/3 study of EB05 should contact email@example.com or visit www.clinicaltrials.gov (Identifier: NCT04401475).
Serious News for Serious Traders! Try StreetInsider.com Premium Free!
You May Also Be Interested In
- FDA grants accelerated approval to sacituzumab govitecan for advanced urothelial cancer
- Novavax (NVAX) announces Gale E. Smith, Ph.D. promoted to Senior Vice President, Greg Covino to step down as CFO
- Johnson & Johnson (JNJ) Vaccine Pause Expected to be Matter of Days, Says FDA
Create E-mail Alert Related CategoriesCorporate News, FDA, Management Comments
Sign up for StreetInsider Free!
Receive full access to all new and archived articles, unlimited portfolio tracking, e-mail alerts, custom newswires and RSS feeds - and more!