Edesa Biotech Achieves Enrollment Milestone in Dermatitis Study

Rhea-AI Summary

Edesa Biotech (NASDAQ:EDSA) has surpassed 50% patient enrollment for the Phase 2b clinical study of its drug candidate, EB01, targeting chronic allergic contact dermatitis. This study evaluates EB01's safety and efficacy in 46 subjects. Previous trials have shown statistically significant symptom improvement. CEO Dr. Par Nijhawan expressed optimism about the recruitment rate during the pandemic and plans for a blinded interim analysis post-first cohort. The annual economic impact of contact dermatitis in the U.S. is estimated at $2 billion, with over 2.5 million people affected.

Positive

• Surpassed 50% enrollment for Phase 2b study of EB01.
• Previous studies of EB01 showed statistically significant improvements in symptoms.
• Encouraging patient recruitment rate despite pandemic challenges.
• Plans for interim analysis could enhance study efficiency.

Negative

• None.

TORONTO, ON / ACCESSWIRE / November 3, 2020 / Edesa Biotech, Inc. (NASDAQ:EDSA), a clinical-stage biopharmaceutical company, today announced that it has completed enrollment of more than 50% of the patients planned for the first cohort of a Phase 2b clinical study evaluating the company's drug candidate as a monotherapy for chronic allergic contact dermatitis.

The adaptive, double-blind study is evaluating the safety and efficacy of EB01 cream in approximately 46 subjects in the first cohort. EB01 is an investigational medicine that contains a non-steroidal anti-inflammatory compound known as an sPLA2 inhibitor. In two previous clinical studies EB01 has demonstrated statistically significant improvement of multiple symptoms in ACD patients.

Dr. Par Nijhawan, Chief Executive Officer of Edesa, said that the company plans to perform a blinded interim analysis following the completion of the first cohort. This adaptive protocol design is intended to make the study more flexible and efficient, and will determine the total number of patients for the second part of the study.

"The patient recruitment rate for our EB01 Phase 2b study in the context of the pandemic is very encouraging. We have now passed the halfway mark for the first cohort and look forward to the trial continuing to progress toward the interim analysis," said Dr. Nijhawan. "We are grateful to the physicians, research staff and participating patients for enabling us to reach this important milestone and encouraged by the interest expressed by the dermatology community for the non-steroidal novel mechanism employed by EB01."

Contact dermatitis, which can be either irritant contact dermatitis or ACD, is one of the most common occupational health illnesses in the United States. The disease has been estimated to cost up to $2 billion annually as a result of lost work, reduced productivity, medical care and disability payments. Edesa estimates that there are more than 2.5 million people in the U.S. with allergic contact dermatitis, with academic literature pointing to a potentially larger undiagnosed population. More than one million patients are estimated to have chronic ACD. To the company's knowledge there are currently no treatment options specifically labelled for ACD.

Additional details about the Phase 2b trial of EB01 (NCT03680131) can be found at www.clinicaltrials.gov.

About Edesa Biotech, Inc.

Edesa Biotech, Inc. (Nasdaq: EDSA) is a clinical-stage biopharmaceutical company focused on developing innovative treatments for inflammatory and immune-related diseases with clear unmet medical needs. Edesa's lead product candidate, EB01, is a novel non-steroidal anti-inflammatory molecule (sPLA2 inhibitor) for the treatment of chronic allergic contact dermatitis which has demonstrated statistically significant improvements in multiple clinical studies. The company is developing late-stage monoclonal antibodies that block certain immune signaling proteins, known as TLR4 and CXCL10. These molecules are associated with a broad range of diseases, including the inflammation associated infectious diseases. Due to the global health emergency, Edesa has prioritized the development of EB05 as a potential treatment for hospitalized COVID-19 patients. The company is based in Markham, Ontario, Canada, with a U.S. subsidiary located in Southern California. Sign up for news alerts.

Edesa Forward-Looking Statements
This press release may contain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements may be identified by the use of words such as "anticipate," "believe," "plan," "estimate," "expect," "intend," "may," "will," "would," "could," "should," "might," "potential," or "continue" and variations or similar expressions, including statements related to: the company's plans regarding its Phase 2b clinical study. Readers should not unduly rely on these forward-looking statements, which are not a guarantee of future performance. There can be no assurance that forward-looking statements will prove to be accurate, as all such forward-looking statements involve known and unknown risks, uncertainties and other factors which may cause actual results or future events to differ materially from the forward-looking statements. Such risks include: the ability of Edesa to obtain regulatory approval for or successfully commercialize any of its product candidates, the risk that access to sufficient capital to fund Edesa's operations may not be available or may be available on terms that are not commercially favorable to Edesa, the risk that Edesa's product candidates may not be effective against the diseases tested in its clinical trials, the risk that Edesa fails to comply with the terms of license agreements with third parties and as a result loses the right to use key intellectual property in its business, Edesa's ability to protect its intellectual property, the timing and success of submission, acceptance and approval of regulatory filings, and the impacts of public health crises, such as COVID-19. Many of these factors that will determine actual results are beyond the company's ability to control or predict. For a discussion of further risks and uncertainties related to Edesa's business, please refer to Edesa's public company reports filed with the U.S. Securities and Exchange Commission and the British Columbia Securities Commission. All forward-looking statements are made as of the date hereof and are subject to change. Except as required by law, Edesa assumes no obligation to update such statements.

Contacts
Gary Koppenjan
Edesa Biotech, Inc.
(805) 488-2800 ext. 150
investors@edesabiotech.com

SOURCE: Edesa Biotech

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FAQ

What is the current status of Edesa Biotech's Phase 2b study for EB01?

Edesa Biotech has completed over 50% patient enrollment for the Phase 2b study evaluating EB01 for chronic allergic contact dermatitis.

What symptoms has EB01 shown to improve according to previous studies?

EB01 has demonstrated statistically significant improvement in multiple symptoms associated with allergic contact dermatitis.

How many patients are involved in the Phase 2b study of EB01?

The Phase 2b study involves approximately 46 subjects in its first cohort.

What is the expected economic impact of contact dermatitis in the U.S.?

Contact dermatitis is estimated to cost up to $2 billion annually due to lost work and medical expenses.

Is there a treatment specifically labeled for allergic contact dermatitis currently?

To date, there are no treatment options specifically labeled for allergic contact dermatitis.