Related Article: Edesa Receives Approval to Proceed with U.S. Clinical Study
TORONTO, ON / ACCESSWIRE / July 25, 2019 / Edesa Biotech, Inc. (NASDAQ: EDSA), a clinical-stage biopharmaceutical company, reported today that the company has completed the manufacturing of its lead drug candidate EB01, a novel sPLA2 inhibitor that Edesa is developing as a potential treatment for chronic allergic contact dermatitis (ACD). Edesa is currently evaluating investigational centers in the U.S. and expects to proceed with enrolling the first patient into its Phase 2b clinical trial in the current quarter.
“We have completed the manufacturing of our active pharmaceutical ingredient and have the drug product for the first cohort ready to distribute to our investigational centers in the U.S.,” said Michael Brooks, President of Edesa. “During our site evaluation visits, we have been encouraged by the high level of interest from physicians familiar with the limited treatment options for chronic suffers of ACD.”
The company’s Phase 2b adaptive designed study of EB01 in chronic ACD will primarily evaluate safety and efficacy. Secondary and exploratory measures will evaluate symptom reduction, quality of life and dose-relationships among various strengths of EB01 cream.
“Based on encouraging results from two previous clinical studies, we believe our novel therapy has the potential to be an effective and safe treatment for patients with ACD. Our upcoming Phase 2b study of EB01 supports our goal to develop therapies for patients with serious unmet medical needs, particularly in inflammatory conditions where current treatments have serious limitations or side effects.”
– Dr. Par Nijhawan, Chief Executive Officer of Edesa
The company recently announced the receipt of an FDA “safe to proceed” letter, which formally approved the company’s Phase 2b clinical protocol and authorized Edesa to begin its clinical investigation.
About Allergic Contact Dermatitis (ACD)
Contact dermatitis, which can be either irritant contact dermatitis or ACD, is one of the most common occupational health illnesses in the United States and has been estimated to cost $2 billion annually as a result of lost work, reduced productivity, medical care, and disability payments. Edesa Biotech estimates that there are more than 13.2 million people in the U.S. with contact dermatitis, with between 20% and 60% of all cases diagnosed as ACD. Approximately 1.2 million patients have chronic ACD. There are no treatment options specifically indicated for ACD and physicians must utilize agents approved for other dermatology conditions, such as topical corticosteroids, which are able to manage disease symptoms in less than half of patients and have well-known side-effects.
About Edesa Biotech, Inc.
Edesa Biotech, Inc. (Nasdaq: EDSA) is a clinical-stage biopharmaceutical company focused on efficiently developing innovative treatments that address significant 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. Edesa’s investigational new drug (IND) application for EB01 was accepted by the FDA in November 2018. Edesa also intends to expand the utility of its sPLA2 inhibitor technology, which forms the basis for EB01, across multiple indications and expand its portfolio with assets that can drive long-term growth opportunities. The company is based in Toronto, Canada, with U.S. offices in Southern California.
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 expectation that it will enroll the first patient into its Phase 2b clinical trial in the current quarter and the company’s goal to rapidly develop therapies for patients with serious unmet medical needs, particularly in inflammatory conditions where current treatments have serious limitations or side effects. 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 and the timing and success of submission, acceptance and approval of regulatory filings. 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.