Edesa Biotech Reports Topline Phase 2b Results for Dermatology Drug

Rhea-AI Summary

Edesa Biotech announced promising topline results from a Phase 2b clinical trial evaluating the 1.0% EB01 cream for moderate-to-severe allergic contact dermatitis (ACD). The trial, involving 200 subjects, showed that the 1.0% formulation achieved a statistically significant 60% average improvement in symptoms compared to 39% for the placebo (p=0.02) at day 29. Additionally, 53% of patients treated with EB01 reached 'clear' or 'almost clear' skin, versus 29% in the placebo group (p=0.04). No serious treatment-related adverse events were reported. Edesa plans to meet with the FDA for an End of Phase 2 discussion following a complete analysis expected mid-2023.

Positive

• 1.0% EB01 cream showed a 60% improvement in allergic contact dermatitis symptoms (CDSI) at day 29 (p=0.02).
• 53% of EB01-treated patients achieved 'clear' or 'almost clear' skin by day 29 (p=0.04).
• No serious treatment-related adverse events were reported, indicating a favorable safety profile.
• The 1.0% formulation, being the lowest effective dose, could lead to significantly lower production costs.

Negative

• The 2.0% and 0.2% formulations did not show significant improvements over placebo.
• -

• Study successfully identified lowest effective dose
• 1.0% formulation reached primary endpoint with statistical significance
• Company preparing for End of Phase 2 meeting with FDA following full analysis

TORONTO, ON / ACCESSWIRE / January 17, 2023 / Edesa Biotech, Inc. (NASDAQ:EDSA), a clinical-stage biopharmaceutical company focused on inflammatory and immune-related diseases, today announced preliminary, topline results from a Phase 2b clinical study evaluating multiple concentrations of the company's drug candidate, EB01, as a monotherapy for moderate-to-severe chronic Allergic Contact Dermatitis (ACD).

The double-blind, placebo-controlled trial evaluated the safety and efficacy of EB01 in approximately 200 subjects, who were treated for 28 days with either EB01 cream (2.0%, 1.0% or 0.2%) or a placebo/vehicle cream. The primary efficacy outcome measurement was the mean percent improvement in symptoms from baseline at day 29 on the Contact Dermatitis Severity Index (CDSI). A key secondary efficacy measurement was the success rate of subjects achieving a score of "clear" or "almost clear" with at least a 2-point improvement from baseline after treatment at day 29 on the Investigator's Static Global Assessment (ISGA) scale.

Edesa reported that 1.0% EB01 cream demonstrated statistically significant improvement over placebo. For the primary endpoint, patients with 1.0% EB01-treated lesions demonstrated a 60% average improvement in symptoms from baseline at day 29 on the CDSI versus 39% for placebo/vehicle (p=0.02). The effect was also observed at 15 days (44% for 1.0% EB01 vs 29% for placebo; p=0.05) and continued at follow-up (64% for 1.0% EB01 vs. 44% for placebo; p=0.04). For the ISGA secondary efficacy endpoint, 53% of patients with 1.0% EB01-treated lesions achieved a score of "clear" or "almost clear" with at least a 2-point improvement from baseline after treatment at day 29 (p=0.04). Only 29% of patients in the placebo group reached the same endpoint. No serious treatment-related adverse events were reported across all concentrations. The 2.0% and 0.2% formulations did not show significant differences compared to placebo (for detailed topline results, please see tables below).

"We are pleased that the study findings demonstrated that the 1.0% EB01 cream helped patients with moderate-to-severe disease significantly reduce their symptoms and achieve clear or almost clear skin in more than half the cases. A significant improvement was evident as early as two weeks from initiation of treatment," said Par Nijhawan, MD, Chief Executive Officer of Edesa. "The favorable topline results from this arm of the study underscore the potential of the drug's powerful anti-inflammatory effect and our belief that EB01 could become a standard of care treatment option for patients living with chronic allergic contact dermatitis."

Dr. Nijhawan noted that while the company anticipated that the highest concentration would also outperform placebo, the favorable topline results from the 1.0% concentration represented the lowest efficacious dose (which was a key part of the study design) and could have a number of benefits going forward, including significantly lower costs of goods.

Edesa is preparing for an End of Phase 2 meeting with FDA following full analysis. The company expects to complete the analysis of the Phase 2b data by midyear.

Summary of Topline Data
The following tables summarize the preliminary, topline data from the Phase 2b study of EB01 topical cream in patients with moderate-to-severe chronic ACD.

1.0% EB01 CREAM VS. PLACEBO/VEHICLE

Percent Reduction in Contact Dermatitis Severity Index (CDSI)*

		Treatment Group
Outcome		Placebo Vehicle (n= 84)				EB01 1.0% Cream (n=19)
Percent Change in CDSI from Baseline at Day 29
Mean (± SD)		-39.25 (34.49)				-59.94( 32.20)
95% CI for Mean		(-46.73,-31.76)				(-75.46,-44.42)
Median (IQR)		-38.75				-66.67
P-Value						0.02

Achievement of Endpoint for Investigator's Static Global Assessment (ISGA)**

		Treatment Group
Outcome		Placebo Vehicle (n= 84)			EB01 1.0% Cream (n=19)			P-Value
≥2 grade reduction to clear or almost clear in ISGA from baseline at Day 29, % (n)		28.6%	(24)		52.6%	(10)		0.04

2.0% EB01 CREAM VS. PLACEBO/VEHICLE

Percent Reduction in Contact Dermatitis Severity Index (CDSI)*

		Treatment Group
Outcome		Placebo Vehicle (n= 84)			EB01 2.0% Cream (n=81)
Percent Change in CDSI from Baseline at Day 29
Mean (± SD)		-39.25 (34.49)			-38.81 (33.28)
95% CI for Mean		(-46.73,-31.76)			(-46.16,-31.45)
Median (IQR)		-38.75			-36.35
P-Value					0.93

Achievement of Endpoint for Investigator's Static Global Assessment (ISGA)**

		Treatment Group
Outcome		Placebo Vehicle (n= 84)			EB01 2.0% Cream (n=81)			P-Value
≥2 grade reduction to clear or almost clear in ISGA from baseline at Day 29, % (n)		28.6%	(24)		24.7%	(20)			0.57

0.2% EB01 CREAM VS. PLACEBO/VEHICLE

Percent Reduction in Contact Dermatitis Severity Index (CDSI)*

		Treatment Group
Outcome		Placebo Vehicle (n= 84)			EB01 0.2% Cream (n=19)
Percent Change in CDSI from Baseline at Day 29
Mean (± SD)		-39.25 (34.49)			-40.59 (38.99)
95% CI for Mean		(-46.73,-31.76)			(-59.38,-21.79)
Median (IQR)		-38.75			-40
P-Value					0.88

Achievement of Endpoint for Investigator's Static Global Assessment (ISGA)**

		Treatment Group
Outcome		Placebo Vehicle (n= 84)			EB01 0.2% Cream (n=19)			P-Value
≥2 grade reduction to clear or almost clear in ISGA from baseline at Day 29, % (n)		28.6%	(24)		36.8%	(7)			0.48

TREATMENT EMERGENT ADVERSE EVENTS - ALL CONCENTRATIONS

Summary of Incidents of Treatment Emergent Adverse Events***

	Treatment Group
	Placebo/Vehicle (n= 84)				EB01 2.0% Cream (n=81)				EB01 1.0% Cream (n=19)				EB01 0.2% Cream (n=19)
Parameter	Number of Events		Subjects (%)		Number of Events		Subjects (%)		Number of Events		Subjects (%)		Number of Events		Subjects (%)
Overall	35		21(25%)		53		30(37%)		0		0(0%)		1		1(5%)
Severity, n (%)
Mild	23		15(18%)		35		21(26%)		0		0(0%)		1		1(5%)
Moderate	7		6(7%)		15		5(19%)		0		0(0%)		0		0(0%)
Severe	5		2(2%)		3		3(4%)		0		0(0%)		0		0(0%)
Seriousness, n (%)
No	34		21(25%)		53		30(37%)		0		0(0%)		1		1(5%)
Yes	1		1(1%)		0		0(0%)		0		0(0%)		0		0(0%)

* Intention to Treat (ITT) population; statistical analysis based on last observation carried forward (LOCF). Improvement was defined as a decrease in CDSI score, which is the sum of the severity scores of five clinical features (scaling, redness, itching, fissures and dryness) from 0 (none) to 3 (severe) for each feature, for a total score of 0 to 15.
** Intention to Treat (ITT) population; statistical analysis based on last observation carried forward (LOCF). The ISGA is a 5-point scale that provides a global clinical assessment of severity based on an ordinal scale, scored by an investigator or physician. A decrease in score relates to an improvement in signs and symptoms.
*** Excluding any events related to dermatitis or worsening of symptoms, which are captured in the CDSI and ISGA analysis.

About Allergic Contact Dermatitis
Contact dermatitis, which can be either irritant contact dermatitis or ACD (sometimes called allergic contact eczema), 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 in the U.S. as a result of lost work, reduced productivity, medical care and disability payments. The condition is caused by an allergen interacting with skin, usually on the hands and face. Inflammation can vary from irritation and redness to open sores, and in many chronic cases, the causative allergen is unknown or difficult to avoid. Approximately 3,000 substances are recognized as contact allergens.

About Edesa Biotech
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. Sign up for news alerts . Connect with us on Twitter and LinkedIn .

Contact Dermatitis Clinical Program
EB01, a non-steroidal anti-inflammatory compound that inhibits secretory phospholipase 2 (sPLA2) as a treatment for the symptoms of chronic allergic contact dermatitis (ACD)

EB01 is a topical vanishing cream that exerts its anti-inflammatory activity through the inhibition of sPLA2 pro-inflammatory enzymes. The sPLA2 enzyme family plays a key role in initiating inflammation associated with numerous diseases. By targeting sPLA2 with enzyme inhibitors - at the inception of inflammation rather than after inflammation has occurred - Edesa believes that drugs based on this technology could provide a powerful anti-inflammatory therapeutic strategy for treating diverse inflammatory/allergic conditions. EB01 has demonstrated efficacy for the treatment of ACD in two previous clinical trials, and has demonstrated anti-inflammatory activity in a variety of in vitro and in vivo preclinical pharmacology models.

ARDS Clinical Program
EB05, a novel monoclonal antibody targeting Toll-like Receptor 4 (TLR4) as a critical care therapy for Acute Respiratory Distress Syndrome (ARDS) - Phase 3: Enrolling

EB05 inhibits signaling through TLR4 - a key pattern recognition receptor involved in the activation of the innate immune system. Excessive TLR4 pathway activation can be pathological and has been linked to various inflammatory conditions, including viral-mediated acute lung injury.

EB05 has extensive preclinical and clinical experience, including evaluations in more than 600 hospitalized Covid-19 subjects. In an international Phase 2 study, a single dose of EB05 demonstrated compelling preliminary evidence of the drug's ability to reduce mortality in target patient populations. Among the results, critically ill hospitalized Covid-19 patients given EB05 plus standard of care treatment had an 84% reduction in the risk of dying when compared to placebo plus standard of care at 28 days.

Cautionary Note Regarding Clinical Studies
Topline results are preliminary in nature, and further analysis may result in additional, different or inconsistent findings to those described in this press release. As such, these topline or interim results should not be considered the complete, final or definitive results of the Phase 2b study.

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 belief that the favorable topline results from the 1% arm of the study underscore the potential of the drug's powerful anti-inflammatory effect and that EB01 could become a standard of care treatment option for patients living with chronic allergic contact dermatitis; the company's belief that the 1% dose could have a number of benefits going forward, including significantly lower costs of goods; the company's plans to have an End of Phase 2 meeting with FDA following full analysis; the expectation to complete the analysis of the Phase 2b data by midyear; the company's belief that anti-inflammatory technology used in EB01 could provide a powerful anti-inflammatory therapeutic strategy for treating diverse inflammatory/allergic conditions; and the company's timing and plans regarding its clinical studies. 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, Inc.

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FAQ

What were the results of the Phase 2b clinical study for Edesa's EB01?

The 1.0% EB01 cream demonstrated a 60% average improvement in symptoms at day 29 compared to 39% for the placebo.

What is the next step for Edesa Biotech regarding EB01?

Edesa is preparing for an End of Phase 2 meeting with the FDA expected after mid-2023.

How many subjects participated in the Phase 2b trial of EB01?

Approximately 200 subjects were treated during the double-blind, placebo-controlled trial.

What safety profile was observed in the EB01 clinical trial?

No serious treatment-related adverse events were reported across all formulations.

What percentage of patients treated with EB01 achieved clear skin?

53% of patients treated with the 1.0% EB01 cream achieved a score of 'clear' or 'almost clear'.