Clinical Pipeline

Novel Approaches to Acute and Chronic Conditions

Edesa is exploring new ways to treat inflammatory and autoimmune diseases, including innovative alternatives to topical steroids, which can have serious side-effects.

Clinical Pipeline Status

As of April 2020

Our current clinical studies are designed to further evaluate safety and efficacy. Since many of these drug candidates come to us with well characterized efficacy and safety data, we avoid much of the lengthy  process of preclinical R&D studies and advance to meaningful data readouts more quickly.

Dermatological Diseases

Allergic Contact Dermatitis

Platform
sPLA2 Inhibitor

Product Candidate
EB01

Product Information
EB01 is a novel sPLA2 inhibitor for the topical treatment of chronic Allergic Contact Dermatitis (ACD). EB01 employs a novel mechanism of action and in two clinical studies has demonstrated statistically significant improvement of multiple symptoms in contact dermatitis patients.

Disease State
Contact dermatitis is one of the most common occupational health illnesses in the United States, and has been estimated to cost approximately $2 billion annually. We estimate that there are more than 13.2 million people in the United States with contact dermatitis, with between 20% and 60% of all cases of contact dermatitis diagnosed as ACD. We believe EB01 will primarily benefit those who have chronic ACD.

Development Status
Edesa is in the early stages of conducting a double-blind, dose-ranging vehicle-controlled adaptive design clinical trial to evaluate the safety and efficacy of EB01 in a population with moderate to severe allergic contact dermatitis

Vitiligo
Platform
Immunotherapy – Monoclonal antibody

Disease State
Vitiligo is a life-altering autoimmune disease that results in the depigmenting of the skin. People who have vitiligo develop white patches of skin due to the destruction of special cells called melanocytes which produce the skin pigment melanin. The cause of vitiligo is not known but evidence strongly suggests that vitiligo is an autoimmune disorder in which the body’s immune system mistakenly targets and injures these cells. Vitiligo can affect any area of skin, but it commonly occurs on the face, neck and hands. According to the World Health Organization, vitiligo affects approximately 1% of the world’s population. It is a lifelong condition.

Despite high prevalence, vitiligo remains one of the most untouched areas in modern medical treatments and there has been little research compared to other immune disorders. Currently there are few treatment options available for patients with limited efficacy.

Development Status
We are working with the National Research Council of Canada (NRC) to develop novel immunotherapies for vitiligo as well as other indications. NRC scientists will produce multiple monoclonal antibodies for Edesa to identify a lead candidate to take into IND-enabling studies.

Additional Dermatological Indications

Platform
sPLA2 Inhibitor and Others

Development Status
Edesa also intends to expand the utility of its sPLA2 inhibitor technology across multiple indications.

Gastrointestinal Diseases

Hemorrhoids

Current Platform
sPLA2 Inhibitor

Product Candidate
EB02

Product Information
EB02 is a novel sPLA2 inhibitor for the treatment of hemorrhoids. 

Disease State
Hemorrhoids affect ~12.5 million adults in the US. Each year 3 million prescriptions are written in the U.S. for hemorrhoids, in addition to 22 million over the counter units. Current treatments entered the market prior to 1962 and provide only temporary relief from symptoms.

Development Status
Edesa is planning to evaluate EB02 in a proof-of-concept study to aid in the design of subsequent clinical studies needed for approval.

Anal Fissures and Additional GI Indications

Platform
Not disclosed

Product Candidate
EB04

Disease State

Anal fissure affect 2-3% of adults in the US. Treatments start with diet modification, stool softeners and steroids, and may include surgery.

Development Status
In-licensed. We are also in discussions to expand our portfolio with assets to treat other serious gastrointestinal conditions.

Infectious Diseases

Acute Respiratory Distress Syndrome

Current Platform
Monoclonal antibodies (mAbs)

Product Candidates
EB05 and EB06

Product Information
EB05 and EB06 are mAbs targeting TLR4 and the chemokine CXCL10, respectively.

Disease State

Acute respiratory distress syndrome (ARDS) is a life-threatening form of respiratory failure, and the leading cause of death among COVID-19 patients. Prior to COVID-19, ARDS accounted for 10% of intensive care unit admissions, representing more than 3 million patients globally each year. ARDS has historically affected approximately 200,000 patients each year in the United States, resulting in nearly 75,000 deaths annually.

Development Status
Due to the global health crisis, Edesa is planning to prioritize the evaluation of EB05 and EB06 as potential treatments for moderate to severe cases of COVID-19.

sPLA2 Inhibitors

We believe that targeting the sPLA2 enzyme family with enzyme inhibitors will have a superior therapeutic effect because the inflammatory process will be inhibited at its inception rather than after inflammation has occurred.

TLR4 and CXCL10 Inhibitors

Countering Hyper-Immune Responses

Our novel monoclonal antibodies suppress certain immune signaling proteins, known as TLR4 and CXCL10. These molecules are associated with a broad range of diseases, including the inflammation associated with infectious diseases like COVID-19.

Patient Enrollment

To view a listing of clinical trials open to patient enrollment that include Edesa’s investigational medicines, please visit the U.S. National Library of Medicine