paridiprubart (EB07) / Edesa Biotech, LightChain Bioscience - LARVOL DELTA

A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of EB05 + SOC vs. Placebo + SOC in Adult Hospitalized Patients With COVID-19 (clinicaltrials.gov) - P2/3 | N=278 | Terminated | Sponsor: Edesa Biotech Inc. | N=644 ➔ 278 | Suspended ➔ Terminated; Edesa has made the decision to terminate this study solely for business reasons. The study termination was not related to any safety concerns.

Enrollment change • Trial termination • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Edesa Biotech, Inc…reported favorable exploratory data for paridiprubart, its first-in-class anti-TLR4 monoclonal antibody, in patients with acute kidney injury (AKI) and respiratory distress. (GlobeNewswire) - "Paridiprubart + SOC reduced adjusted 28-day mortality to 33% (95% CI: 28%–39%) from 49% (95% CI: 41%–57%) with placebo + SOC, a 32% relative reduction in the risk of death (nominal p<0.005)...Using the same multivariate logistic regression methodology, paridiprubart + SOC reduced the adjusted incidence of MAKE30 at Day 30 to 41% (95% CI: 36%–46%) from 53% (95% CI: 47%–60%) with placebo + SOC, a 23% relative reduction in MAKE30 incidence (nominal p<0.005). MAKE30 is a composite endpoint comprising all-cause mortality, initiation of renal replacement therapy, or persistent renal dysfunction through Day 30...Paridiprubart was well tolerated in the AKI subpopulation."

Retrospective data • Acute Kidney Injury • Acute Respiratory Distress Syndrome • Immunology

Exploratory analysis of paridiprubart, an anti-TLR4 antibody, in patients with acute kidney injury and respiratory distress (ERA 2026) - "Given that current SOC for AKI remains predominantly supportive, these findings highlight the potential therapeutic value of targeting TLR4-mediated inflammation in this population. Paridiprubart may represent a promising novel treatment option for patients with respiratory distress complicated by AKI, warranting further investigation into its mechanism, optimal patient selection, and potential role across broader AKI etiologies."

Clinical • Acute Kidney Injury • Infectious Disease • Inflammation • Nephrology • Novel Coronavirus Disease • Renal Disease • Respiratory Diseases • TLR4

A Phase 3, Multicenter, Double-blind, Placebo Controlled Study of an Anti-TLR4 Antibody, Paridiprubart, in Adult Patients With Respiratory Distress on Invasive Mechanical Ventilation (ATS 2026) - No abstract available

Clinical • P3 data • Acute Respiratory Distress Syndrome • Pulmonary Disease • Respiratory Diseases • TLR4

JUST BREATHE, Breathing Life Into Innovative Therapies for ARDS (Master Record) (clinicaltrials.gov) - P2 | N=600 | Recruiting | Sponsor: PPD Development, LP | Trial completion date: Feb 2028 ➔ Sep 2028 | Trial primary completion date: Nov 2027 ➔ Jul 2028

Trial completion date • Trial primary completion date • Acute Respiratory Distress Syndrome • Pulmonary Disease • Respiratory Diseases

JUST BREATHE, Breathing Life Into Innovative Therapies for ARDS- Cohort B: Paridiprubart (clinicaltrials.gov) - P2 | N=200 | Recruiting | Sponsor: PPD Development, LP | Trial completion date: Feb 2028 ➔ Sep 2028 | Trial primary completion date: Nov 2027 ➔ Jul 2028

Trial completion date • Trial primary completion date • Acute Respiratory Distress Syndrome • Pulmonary Disease • Respiratory Diseases

JUST BREATHE, Breathing Life Into Innovative Therapies for ARDS (Master Record) (clinicaltrials.gov) - P2 | N=600 | Recruiting | Sponsor: PPD Development, LP | Initiation date: Feb 2025 ➔ Jun 2025

Trial initiation date • Acute Respiratory Distress Syndrome • Pulmonary Disease • Respiratory Diseases

Edesa Biotech Reports Fiscal 2nd Quarter 2025 Results (GlobeNewswire) - "Total operating expenses decreased by $0.6 million to $1.6 million for the three months ended March 31, 2025 compared to $2.2 million for the three months ended March 31, 2024: Research and development expenses decreased by $0.7 million to $0.5 million for the three months ended March 31, 2025 compared to $1.2 million for the same period last year primarily due to decreased external research expenses related to manufacturing the company’s investigational drug, paridiprubart..."

Commercial • Idiopathic Pulmonary Fibrosis • Scleroderma

JUST BREATHE, Breathing Life Into Innovative Therapies for ARDS- Cohort B: Paridiprubart (clinicaltrials.gov) - P2 | N=200 | Recruiting | Sponsor: PPD DEVELOPMENT, LP | Not yet recruiting ➔ Recruiting

Enrollment open • Acute Respiratory Distress Syndrome • Pulmonary Disease • Respiratory Diseases

JUST BREATHE, Breathing Life Into Innovative Therapies for ARDS (Master Record) (clinicaltrials.gov) - P2 | N=600 | Recruiting | Sponsor: PPD DEVELOPMENT, LP | Not yet recruiting ➔ Recruiting

Enrollment open • Acute Respiratory Distress Syndrome • Pulmonary Disease • Respiratory Diseases

JUST BREATHE, Breathing Life Into Innovative Therapies for ARDS (Master Record) (clinicaltrials.gov) - P2 | N=600 | Not yet recruiting | Sponsor: PPD DEVELOPMENT, LP

New P2 trial • Acute Respiratory Distress Syndrome • Pulmonary Disease • Respiratory Diseases

JUST BREATHE, Breathing Life Into Innovative Therapies for ARDS- Cohort B: Paridiprubart (clinicaltrials.gov) - P2 | N=200 | Not yet recruiting | Sponsor: PPD DEVELOPMENT, LP

New P2 trial • Acute Respiratory Distress Syndrome • Pulmonary Disease • Respiratory Diseases

A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of EB05 + SOC Vs. Placebo + SOC in Adult Hospitalized Patients with COVID-19 (clinicaltrials.gov) - P2/3 | N=644 | Suspended | Sponsor: Edesa Biotech Inc. | Recruiting ➔ Suspended

Trial suspension • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Edesa Biotech Reports Fiscal 3rd Quarter 2024 Results (GlobeNewswire) - "Research and development expenses decreased by $0.1 million to $0.9 million for the three months ended June 30, 2024 compared to $1.0 million for the same period last year primarily due to decreased external research expenses related to the company’s ongoing Phase 3 ARDS study and its completed dermatitis study, which were partially offset by an increase in expenses related to manufacturing of the company’s investigational drug, paridiprubart."

Commercial • Acute Respiratory Distress Syndrome • Idiopathic Pulmonary Fibrosis • Immunology • Respiratory Diseases • Scleroderma • Systemic Sclerosis

A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of EB05 + SOC vs. Placebo + SOC in Adult Hospitalized Patients With COVID-19 (clinicaltrials.gov) - P2/3 | N=644 | Recruiting | Sponsor: Edesa Biotech Inc. | Phase classification: P2 ➔ P2/3 | N=396 ➔ 644 | Trial completion date: Apr 2021 ➔ Dec 2024 | Trial primary completion date: Apr 2021 ➔ Dec 2024

Enrollment change • Phase classification • Trial completion date • Trial primary completion date • Infectious Disease • Novel Coronavirus Disease

"@EdesaBiotech starting Phase 3 EB05 trials for Severe COVID any day now" (,@JoeB_204)

P3 data • Novel Coronavirus Disease

Edesa Biotech to Study Its Investigational Drug as Potential Rescue Therapy (Yahoo Finance) - "Edesa Biotech, Inc....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...The sub-study will evaluate the drug as a potential rescue therapy for critically severe COVID-19 cases....Edesa's sub-study is expected to enroll up to 100 ICU patients with severe COVID-19 symptoms....Should the antibody treatment demonstrate promising results at the Phase 2 readout, the company plans to continue with a pivotal Phase 3 study."

Trial status • Infectious Disease • Novel Coronavirus Disease

Edesa Biotech Expands COVID-19 Clinical Study to Colombia (Yahoo Finance) - "Edesa Biotech, Inc....has received approval from the Ministry of Health (INVIMA) in Colombia to expand the clinical trial of its investigational drug EB05 in hospitalized COVID-19 patients. The study was previously approved in the U.S. and Canada, where enrollment is ongoing. The company reported that it has enlisted the support of a local research organization and will begin activating hospital sites in Bogota, Medellín, Bucaramanga, and other major metropolitan centers."

Trial status • Infectious Disease • Novel Coronavirus Disease

A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of EB05 + SOC vs. Placebo + SOC in Adult Hospitalized Patients With COVID-19 (clinicaltrials.gov) - P2; N=396; Recruiting; Sponsor: Edesa Biotech Inc.; Not yet recruiting ➔ Recruiting; Phase classification: P2/3 ➔ P2; N=865 ➔ 396

Clinical • Enrollment change • Enrollment open • Phase classification • Infectious Disease • Novel Coronavirus Disease • CRP • IL6

Edesa Biotech (EDSA) Reports FDA Approval to Begin COVID-19 Study in the U.S. (Streetinsider.com) - "Edesa Biotech, Inc....has received clearance from the U.S. Food and Drug Administration (FDA) to begin the Phase 2 portion of its Phase 2/3 clinical study of its investigational drug, EB05, for the treatment of hospitalized COVID-19 patients....The company has begun the site initiation process at U.S. hospitals....'Our EB05 study has been deemed safe to proceed by the FDA, marking another milestone in our plans to begin patient enrollment'....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."

Trial initiation date • Novel Coronavirus Disease

A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of EB05 + SOC vs. Placebo + SOC in Adult Hospitalized Patients With Moderate to Severe COVID-19 Pneumonia (clinicaltrials.gov) - P2/3; N=865; Not yet recruiting; Sponsor: Edesa Biotech Inc.; Phase classification: P2 ➔ P2/3; N=510 ➔ 865; Trial completion date: Oct 2020 ➔ Apr 2021; Trial primary completion date: Sep 2020 ➔ Feb 2021

Clinical • Enrollment change • Phase classification • Trial completion date • Trial primary completion date • Infectious Disease • Novel Coronavirus Disease • Pneumonia • Respiratory Diseases • CRP • IL6

FDA Nod For JAZZ's Drug, BYSI's PROTECTIVE-2 Trial Meets Goals, EDSA To Begin COVID-19 Drug Trial (Nasdaq) - "Shares of Edesa Biotech Inc. (EDSA) soared as much as 247 percent in intraday reading on Monday, following expedited approval from Health Canada to begin a phase II/III clinical study of its investigational drug, EB05, in moderate to severe COVID-19 patients....EDSA touched a high of $10 in intraday trading before closing the day at $5.80, up 101.39%."

Canadian regulatory • Stock price • Infectious Disease • Novel Coronavirus Disease

Edesa Biotech receives regulatory approval to initiate Covid-19 study (Streetinsider.com) - "Edesa Biotech, Inc....has received expedited approval from Health Canada to begin a Phase 2/3 clinical study of its investigational drug, EB05....The company reported that it has EB05 drug product available now and is seeking government grants to accelerate the initiation and rollout of the study....Should the drug treatment demonstrate promising results at the Phase 2 readout, the protocol allows for enrollment to continue as a pivotal Phase 3 study."

New P3 trial • Trial initiation date • Infectious Disease • Novel Coronavirus Disease

A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of EB05 + SOC vs. Placebo + SOC in Adult Hospitalized Patients With Moderate to Severe COVID-19 Pneumonia (clinicaltrials.gov) - P2; N=510; Not yet recruiting; Sponsor: Edesa Biotech Inc.

Clinical • New P2 trial • Infectious Disease • Novel Coronavirus Disease • Pneumonia • Respiratory Diseases