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Evelo Biosciences Reports Positive EDP1815 Interim Clinical Data in Phase 1b Clinical Trial
Aug. 06, 2019 09:30AM PST
Biotech Investing
Evelo Biosciences (NASDAQ:EVLO) has announced positive interim clinical data from the first cohort of patients in its ongoing Phase 1b clinical trial of EDP1815 in patients with mild-to-moderate psoriasis. As quoted in the press release: 12 patients with mild to moderate psoriasis were randomized 2:1 to receive daily, oral administration of 550mg (1x dose) of …
Evelo Biosciences (NASDAQ:EVLO) has announced positive interim clinical data from the first cohort of patients in its ongoing Phase 1b clinical trial of EDP1815 in patients with mild-to-moderate psoriasis.
As quoted in the press release:
12 patients with mild to moderate psoriasis were randomized 2:1 to receive daily, oral administration of 550mg (1x dose) of EDP1815, or placebo, for 28 days. The primary endpoint was safety and tolerability. Secondary and exploratory endpoints included lesion severity score (LSS), a measure of clinical activity, cellular histological biomarkers and blood immune cell biomarkers taken from biopsies and blood samples, respectively, at the start and end of the 28-day dosing period.
Patients dosed daily for 28 days with 550mg of the enteric capsule formulation of EDP1815 showed a statistically significant (p<0.05) reduction in mean LSS at 28 days of 2 points, compared to a mean increase of 0.25 points in patients who received placebo. Data from patients dosed with EDP1815 showed a reduction in LSS over the dosing period ranging from 0 to 67 percent. LSS, a secondary endpoint, is a component of the Psoriasis Area and Severity Index (PASI) score and measures redness, thickness, and scaling of an individual psoriatic lesion across the dosing period and is a sensitive clinical measure for patients with mild to moderate disease.
Analysis of the change over the dosing period of the basal epithelium mitotic count, a secondary endpoint and a cellular driver of psoriasis pathology, showed a mean reduction of 2.25 cells/mm2 in patients who received EDP1815 compared to no change in patients receiving placebo. Lower basal epithelium mitotic counts indicate a reduction of psoriasis pathology.
In an analysis of blood immune cell cytokine production following stimulation with lipopolysaccharide, an exploratory endpoint, the EDP1815 dosed patient group showed a reduction in cytokine production indicative of a systemic anti-inflammatory response, compared to no reduction in the placebo group.
Evelo plans to advance EDP1815 into Phase 2 in early 2020. This trial will investigate daily dosing of EDP1815 in mild to moderate psoriasis patients over 24 weeks. Multiple doses and formulations of EDP1815 will be investigated.