Edesa Biotech Completes Enrollment for Interim Clinical Study Milestone
Edesa Biotech (NASDAQ:EDSA) recently announced the completion of enrollment for the first cohort in its Phase 2b clinical study of EB01, targeting chronic Allergic Contact Dermatitis (ACD). A total of 46 subjects were randomized and treated with either EB01 or a placebo. EB01, an sPLA2 inhibitor, aims to reduce inflammation without steroid-related safety concerns. The company will conduct a blinded interim analysis post a 28-day treatment period. Edesa is optimistic about the drug's potential, and if the interim results are favorable, the final study phase will proceed.
- Completion of enrollment of 46 subjects for Phase 2b clinical study of EB01.
- EB01 demonstrated statistically significant improvement in previous studies for ACD symptoms.
- Potential to advance quickly into the final study phase if interim analysis meets success thresholds.
- None.
TORONTO, ON / ACCESSWIRE / March 9, 2021 / Edesa Biotech, Inc. (NASDAQ:EDSA), a clinical-stage biopharmaceutical company focused on inflammatory and immune-related diseases, today announced that it has completed enrollment of the first cohort of a Phase 2b clinical study evaluating the company's drug candidate EB01 as a monotherapy for chronic Allergic Contact Dermatitis (ACD), a potentially debilitating condition and occupational illness.
Edesa reported that all 46 subjects in the first cohort have been randomized and dosed with either Edesa's EB01 topical treatment or a placebo cream. EB01 contains a non-steroidal anti-inflammatory compound known as an sPLA2 inhibitor. Since EB01 is designed to inhibit the inflammatory process at its inception rather than after inflammation has occurred, the company believes that the drug could potentially exert a powerful anti-inflammatory effect without the safety concerns of steroids.
Once all the subjects in the first cohort complete the 28-day treatment, Edesa plans to initiate a blinded interim analysis. The interim results will determine the number of patients for the final part of the Phase 2b study based on probability thresholds previously approved by the Food and Drug Administration. In two previous clinical studies EB01 has demonstrated statistically significant improvement of multiple symptoms in ACD patients.
Dr. Par Nijhawan, MD, Chief Executive Officer of Edesa, said that the company is grateful to the patients, physicians and research staff for their participation and diligent work despite the challenges presented by the pandemic.
"We are encouraged by the strong interest in the program. Should the blinded analysis confirm that the probability of success meets or exceeds the predetermined thresholds, we plan to move rapidly into the final part of the study," said Dr. Nijhawan. He noted that enrollment activities for the second half of the Phase 2b study would continue during the interim analysis period.
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
Physicians interested in participating in the study should contact info@edesabiotech.com or visit www.clinicaltrials.gov (Identifier: NCT03680131).
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. The company's two lead product candidates, EB05 and EB01, are in later stage clinical studies. EB05 is a monoclonal antibody therapy that we are developing as a treatment for Acute Respiratory Distress Syndrome (ARDS). ARDS is a life-threatening form of respiratory failure, and the leading cause of death among COVID-19 patients. Edesa is also developing an sPLA2 inhibitor, designated as EB01, as a topical treatment for chronic allergic contact dermatitis (ACD), a common, potentially debilitating condition and occupational illness. EB01 employs a novel, non-steroidal mechanism of action and in two clinical studies has demonstrated statistically significant improvement of multiple symptoms in ACD 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, including its plans to initiate a blinded interim analysis, and the company's belief that EB01 could potentially exert a powerful anti-inflammatory effect without the safety concerns of steroids. 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.
CONTACT:
Gary Koppenjan
Edesa Biotech, Inc.
(805) 488-2800 ext. 150
investors@edesabiotech.com
SOURCE: Edesa Biotech
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FAQ
What is the objective of Edesa's Phase 2b study for EB01?
How many subjects were enrolled in the EB01 clinical study?
What are the expected outcomes from the interim analysis of the study?
What is the significance of EB01 for ACD patients?
When will Edesa commence the final part of the Phase 2b study?
