Technology

Novel Mechanism of Action

sPLA2 inhibitors represent a novel approach treating inflammation without the safety concerns of current therapies.

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Inhibiting the Inflammation Cascade

sPLA2 inhibitors are designed to inhibit the inflammatory process at its inception rather than after inflammation has occurred.

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Efficacy and Durability

In Phase 2a testing, contact dermatitis patients demonstrated 50+% improvement in mean score from baseline and statistically significant  improvement for each symptom vs. placebo. Clear durability demonstrated following treatment.

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Well Tolerated

No serious adverse effects or discontinuations due to adverse events.

EB01 inhibits sPLA2 from degrading phospholipids to produce arachidonic acid. Arachidonic acid is processed via the LOX-COX pathway to produce several pro-inflammatory signaling molecules.  EB01 exerts its anti-inflammatory activity upstream of currently approved NSAIDs, which target the LOX-COX pathway.

Initial Phase 2 Efficacy Study of EB01

For the treatment of allergic contact dermatitis

Mean Percent Improvement from Baseline in Total PVA Score

The bilateral study (n = 30) was conducted to assess 2.0% EB01 cream applied twice daily for 21 consecutive days in connection with the treatment of allergic contact dermatitis (ACD). To be included in the study, patients had to have bilateral ACD with a PVA** score of at least 10 on each side, with no more than a 1-point difference between lesions. At Day 21, EB01-treated lesions had a mean improvement from baseline of 58%, compared to 24% for those treated with placebo cream (p < 0.001).

Improvements were seen for each of the individual PVA parameters graded (dryness, scaling, redness, pruritus, and fissures), indicating that each aspect contributed to the overall effect of the treatment (as shown in Table 1 below). Efficacy of the 2.0% EB01 cream was maintained through Day 42 (21-days after ending treatment) with a 49% decrease in total PVA score for 2.0% EB01 cream-treated hands, compared to 15% in the vehicle-treated hands (p < 0.001).
Improvements were seen for each of the individual PVA parameters graded (dryness, scaling, redness, pruritus, and fissures), indicating that each aspect contributed to the overall effect of the treatment (as shown in table below). Efficacy of the 2.0% EB01 cream was maintained through Day 42 (21-days after ending treatment) with a 49% decrease in total PVA score for 2.0% EB01 cream-treated hands, compared to 15% in the vehicle-treated hands.

** The Physician’s visual assessment (PVA) is a composite endpoint, which grades each symptom of the disease (dryness, scaling, redness, pruritus, and fissures) scored from 0 (none) to 3 (severe), with a maximum severity score of 15. A diagnosis of ACD was confirmed by a positive patch test deemed to be clinically relevant by the investigator.

Percent Change from Baseline to Day 21
Comparison between treatment groups using Paired T-test/Wilcoxon Rank Sum Test (n = 30)

 

Endpoint EB01VehicleP-Value
Total Physicians Visual AssessmentMean % Change from Baseline-56%-24%<0.001
Scaling*Mean % Change from Baseline-48%-20%<0.001
Redness*Mean % Change from Baseline-47%-20<0.001
Pruritis*Mean % Change from Baseline-63%-25%<0.001
Fissures*Mean % Change from Baseline-81%-46%<0.001
Dryness*Mean % Change from Baseline-45%-15%<0.001

* Data are not normally distributed — P-Values result from Wilcoxon Rank Sum test.

Yissum Collaboration

Edesa collaborates with researchers at Hebrew University of Jerusalem and has a license agreement with the university’s tech transfer agent Yissum Research Development Company for our investigational medicines EB01 and EB02.